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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD099125-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study tests the extent to which tailored outreach text messages that provide a cue to action and an intervention that enhances access to poverty-reducing resources, in combination with standard primary care literacy promotion, can improve child language and social- emotional skill acquisition among low-income Latino children.
The investigators propose a 3 arm randomized clinical trial to test strategies designed to enhance literacy promotion for low-income Latino families. The investigators will recruit 630 parent-child dyads from community health centers that serve low-income, Latino families. Parents will be randomly assigned to one of 3 arms (1) Reach Out and Read (ROR) an evidence-based literacy promotion intervention that is widely disseminated in primary care; (2) ROR plus tailored outreach text messages; (3) ROR plus tailored outreach text messages and enhanced access to poverty-reducing resources using a widely disseminated model that simplifies access and provides care coordination. In Aim 1, the investigators will test their hypotheses that (1) children in the ROR plus text message arm will have higher scores on validated assessments of language and social-emotional development compared to standard ROR alone and (2) children who receive both text messages and enhanced access to poverty-reducing resources will have higher scores compared to the other two arms. In Aim 2, the investigators will examine mechanisms that underlie the effects of the interventions. In Aim 3, the investigators will use mixed methods to conduct a process evaluation to understand how the interventions are implemented, identify barriers, facilitators, and modifications, and explore parents' experiences with the interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care including ROR | Active Comparator | Literacy promotion is a pediatric standard of care. Participants in this group will receive usual care that includes ROR, a primary care literacy promotion intervention. |
|
| ROR plus text messages | Experimental | In addition to ROR, participants will receive three text messages per week, plus one interactive follow-up message per month, for the study period with scheduled breaks. |
|
| ROR plus text messages plus connection to community resources | Experimental | In addition to ROR and text messages, participants will be referred to a county-based single point of entry system for referrals to community resources. This system simplifies access to poverty-reducing resources by creating a centralized access point, maintaining an updated data base of resources with existing capacity to support families, and providing case management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care including ROR | Behavioral | Usual care which includes ROR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Child Language Skills | Expressive One-Word Picture Vocabulary Test - Fourth Edition (EOWPVT-4) Spanish-Bilingual - Assesses expressive language skills in English and Spanish. This multiple-choice format test consists of 190 items presented in developmental sequence; age-related starting points and cut-off points ensure that only a subset of items is administered. Raw scores are converted into standard scores (M=100, SD=15). Higher scores denote stronger language skills, with possible standard scores ranging between 55 and 145. | 18-month follow-up |
| Child Communicative Skills | Caregiver report of non-verbal communication and early expressive language assessed using the MacArthur Bates Communicative Development Inventories. The Words & Gestures short form is an 89-word vocabulary checklist with separate columns for comprehension and production for children 8-18 months. The Words & Sentences versions contain a 100-word productive vocabulary checklist and a question about combining words for children 16-30 months. Scores are summed and higher scores denote stronger skills. | 9-month follow-up, 18-month follow-up |
| Child Social-emotional Skills | Child's social-emotional skills were assessed with the Devereux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), which has 2 caregiver-report forms: an infant form (1-18 months) that includes Attachment/Relationships and Initiative subscales, and a toddler form (18-36 months) that includes Attachment/Relationships, Initiative, and Self-Regulation subscales. Scores are standardized on a T-distribution (M=50; SD=10). The Total Protective Factors score is calculated by adding subscale T-scores. T-scores of 60+ indicate an area strength, and T-scores of 40- indicate an area need. | Baseline, 9-month follow-up, 18-month follow-up |
| Caregiver Cognitive Stimulation | The StimQ2 is a caregiver-reported measure of cognitive stimulation for children that includes domains on the home literacy environment (Reading scale) and responsiveness (Parental Verbal Responsiveness scale). The Reading scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the Reading scale range from 0 to 19. The Parental Verbal Responsiveness scale is composed of two subdimensions (Everyday Routines and Play and Pretend). Scores range from 0 to 15. Higher scores indicate more cognitive stimulation. The Reading scale was completed at baseline, the 9-month follow-up, and the 18-month follow-up. The Parent Verbal Responsiveness scale was completed at the 9-month follow-up and the18-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Attitudes About Reading | The Parent Reading Belief Inventory is a caregiver reported measure of attitudes about reading with children that included positive affect (scores range from 0 to 33). Higher scores indicate more favorable attitudes and greater knowledge. | 9-month follow-up, 18-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| ROR Receipt | Caregiver's report of receipt of literacy promotion components during their previous healthcare visit. | Baseline; 9-month follow up; 18-month follow up |
| Observed Parent-child Interactions |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel E Jimenez, MD, MS | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42400022 | Derived | Hemler JR, Jimenez ME, Crabtree BF, Mendelsohn AL, Devine KA, Pai S, Ramachandran U, Hudson SV, Mackie TI. A call for supplemental implementation strategy reporting guidelines to advance minority health: applying expanded specification and reporting recommendations to the Literacy Promotion for Latinos study. Implement Sci Commun. 2026 Jul 3. doi: 10.1186/s43058-026-00966-3. Online ahead of print. | |
| 38127845 | Derived | Zanzoul S, Strickland PO, Mendelsohn AL, Malke K, Bator A, Hemler J, Jimenez ME. Stress and Infant Media Exposure During COVID-19: A Study Among Latino Families. J Dev Behav Pediatr. 2024 Jan 1;45(1):e14-e20. doi: 10.1097/DBP.0000000000001231. Epub 2023 Dec 21. |
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Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement.
Data will become available after the study is completed and primary study findings are published in peer-reviewed journals.
Researchers from accredited institutions may request access to the data for non-profit research. Permission and access will be granted on an ad hoc basis. Only deidentified data will be made available.
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1,129 potential participants were assessed for eligibility, and of these, 467 were excluded, and 662 met inclusion criteria and were consented. Of these 662 participants, 630 were randomized. Of the other 32 who were not randomized, 17 declined to participate and 15 lost contact.
Participants were recruited from three health centers in central New Jersey between November 2020 and June 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual care including ROR | Literacy promotion is a pediatric standard of care. Participants in this group received usual care that includes ROR, a primary care literacy promotion intervention. Usual care including ROR: Usual care which includes ROR. |
| FG001 | ROR plus text messages | In addition to ROR, participants received three text messages per week, plus one interactive follow-up message per month, for the study period with scheduled breaks. Usual care including ROR: Usual care which includes ROR. Text messages: 3 text messages per week and one interactive text per month. |
| FG002 | ROR plus text messages plus connection to community resources | In addition to ROR and text messages, participants were referred to a county-based single point of entry system for referrals to community resources. This system simplifies access to poverty-reducing resources by creating a centralized access point, maintaining an updated data base of resources with existing capacity to support families, and providing case management. Usual care including ROR: Usual care which includes ROR. Text messages: 3 text messages per week and one interactive text per month. Connection to community resources: Referral to a non-profit that connects families with community resources and provides families with case management. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The overall number of baseline participants represents the number of caregiver/child dyads in each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Including ROR | Literacy promotion is a pediatric standard of care. Participants in this group will receive usual care that includes ROR, a primary care literacy promotion intervention. Usual care including ROR: Usual care which includes ROR. |
| BG001 | ROR Plus Text Messages |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of the caregiver in the caregiver/child dyad. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Child Language Skills | Expressive One-Word Picture Vocabulary Test - Fourth Edition (EOWPVT-4) Spanish-Bilingual - Assesses expressive language skills in English and Spanish. This multiple-choice format test consists of 190 items presented in developmental sequence; age-related starting points and cut-off points ensure that only a subset of items is administered. Raw scores are converted into standard scores (M=100, SD=15). Higher scores denote stronger language skills, with possible standard scores ranging between 55 and 145. | Participants include those who had baseline data and completed the EOWPVT at the 18-month follow-up. The EOWPVT was only administered at the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | 18-month follow-up |
|
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Deaths, serious adverse events, and other (non-serious adverse events) were not assessed for study participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual care including ROR | Literacy promotion is a pediatric standard of care. Participants in this group will receive usual care that includes ROR, a primary care literacy promotion intervention. Usual care including ROR: Usual care which includes ROR. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manuel Jimenez, MD, MS | Rutgers University | 732-235-9300 | jimenema@rwjms.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2025 | Sep 17, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2024 | Nov 27, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002652 | Child Behavior |
| D000067010 | Literacy |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003142 | Communication |
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| Text messages | Behavioral | 3 text messages per week and one interactive text per month. |
|
| Connection to community resources | Behavioral | Referral to a non-profit that connects families with community resources and provides families with case management. |
|
| Baseline, 9-month follow-up, 18-month follow-up |
| Dialogic Reading Behavior | The DialogPR is a caregiver report measure of shared reading quality. Score range from 0 to 30 with higher scores indicating more interactive reading. | 9-month follow-up |
| Caregiver Discipline Strategies | This questionnaire was modified from the National Survey of Early Childhood Health and asks two questions about verbal and physical discipline. Scores range from 0 to 6 and higher scores indicate harsher discipline strategies. | 18-month follow-up |
| Community Resource Participation |
Community resource participation was measured via the Survey of Income and Program Participation (SIPP), a series of questions that asks about caregiver and child participation in different types of community resources (e.g. food/nutrition support, income support, childcare assistance, etc.). Possible scores range from 0 to 17, with higher scores indicating more involvement in community resources. |
| Baseline, 9-month follow-up, 18-month follow-up |
| Caregiver-clinician Relationship | The Physician-Parent Communication Survey is a caregiver reported measure of the caregiver-clinician relationship. We analyzed the interest subscale. The interest subscale includes 6 items are scored from 1 to 8. Scores from each item are averaged; thus total possible scores range from 1-8, with higher scores indicating stronger relationships. | Baseline; 9-month follow-up, 18-month follow-up |
| Social Needs and Stress | Caregiver report of social needs and stressors was assessed via the Local Inventory of Needs and Knowledge (LINK) survey. Caregivers rate statements on social needs and stress from 0 to 4 with higher scores indicating greater needs and stress. Possible scores range from 0 to 16 with higher scores indicating greater needs and economic stress. | Baseline, 9-month follow-up, 18-month follow-up |
| Parent Stress | The Parental Stress Scale is an eighteen-item measure that assesses parental stress. Scores range from 18 to 90 with higher scores indicating greater stress. | Baseline, 9-month follow-up, 18-month follow-up |
| Child Media Use | The ScreenQ is a caregiver report measure of media use in children. Scores range from 0 to 26 with higher score indicating more media use. | Baseline, 9-month follow-up, 18-month follow-up |
Observation of parent-child interactions during shared reading and free play; observations will be coded based on DialogPR items
| 9-month follow up |
In addition to ROR, participants will receive three text messages per week, plus one interactive follow-up message per month, for the study period with scheduled breaks. Usual care including ROR: Usual care which includes ROR. Text messages: 3 text messages per week and one interactive text per month. |
| BG002 | ROR Plus Text Messages Plus Connection to Community Resources | In addition to ROR and text messages, participants will be referred to a county-based single point of entry system for referrals to community resources. This system simplifies access to poverty-reducing resources by creating a centralized access point, maintaining an updated data base of resources with existing capacity to support families, and providing case management. Usual care including ROR: Usual care which includes ROR. Text messages: 3 text messages per week and one interactive text per month. Connection to community resources: Referral to a non-profit that connects families with community resources and provides families with case management. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Age of the child in the caregiver/child dyad. | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Sex of the caregiver in the caregiver/child dyad. | Count of Participants | Participants |
|
| Sex: Female, Male | Sex of the child in the caregiver/child dyad. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | All participants self-identified as Latino/a/x as this was part of the inclusion criteria. | Count of Participants | Participants |
|
| Caregiver's Self-reported Rating of Ability to Speak English | Count of Participants | Participants |
|
| Caregiver's Highest Level of Education | Count of Participants | Participants |
|
| Caregiver Health Literacy Score | Health literacy score was assessed using the Short Assessment of Health Literacy (SAHL), and was administered in English or Spanish, based on the participant's language preference. The SAHL has 18 questions, with each question including (1) correctly reading a health-related word aloud, and (2) hearing 2 additional words, and choosing the one most closely related to the original health-related word. Total possible scores range from 0-18, with scores 14 and below indicating low health literacy. | Mean | Standard Deviation | units on a scale |
|
| Child Social-Emotional Skills | Child's social-emotional skills were assessed with the Devereux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), which has 2 caregiver-report forms: an infant form (1-18 months) that includes Attachment/Relationships and Initiative subscales, and a toddler form (18-36 months) that includes Attachment/Relationships, Initiative, and Self-Regulation subscales. Scores are standardized on a T-distribution (M=50; SD=10). The Total Protective Factors score is calculated by adding subscale T-scores. T-scores of 60+ indicate an area strength, and T-scores of 40- indicate an area need. | Mean | Standard Deviation | T-score |
|
| Reading Activities | Reading activities were assessed with the STIMQ2 reading scale, a parent-report measure. Subscales include Quantity, Diversity, and Quality. Total possible scores range from 0 to 19, with higher scores equating to higher quantity, diversity, and quality of shared reading. | Mean | Standard Deviation | units on a scale |
|
| Community Resource Participation | Community resource participation was measures via the Survey of Income and Program Participation (SIPP), a self-reported measure of participation in different types of community resources (e.g., food/nutrition support, income support, childcare assistance, etc.). Possible scores range from 0 to 17, with higher scores indicating more involvement in community resources. | Mean | Standard Deviation | units on a scale |
|
| Caregiver-Clinician Relationship | Caregiver-clinician relationship was assessed with the Modified Physician-Parent Communication Survey, Interest subscale. The interest subscale includes 6 items scored from 1 to 8. Item scores are then averaged. Total possible scores range from 1-8, with higher scores indicating stronger relationships. | Mean | Standard Deviation | units on a scale |
|
| Economic Stress | Economic stress was assessed using the Local Inventory of Needs and Knowledge (LINK). Questions are answered on a 5-point Likert scale of "strongly disagree" (0) to "strongly agree" (4). Possible scores range from 0 to 16 with higher scores indicating greater needs and economic stress. | Mean | Standard Deviation | units on a scale |
|
| Parent Stress | Caregiver stress was measured via the Parental Stress Scale (PSS), an 18-item scale. For each item, parents rate how much they agree or disagree using a 5-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (5). Total possible scores range from 18 to 90 with higher scores indicating more parental stress. | Mean | Standard Deviation | units on a scale |
|
| Child Media Use | Child media use was measured using the Modified ScreenQ-I/T 2.0 (Infant/Toddler) version. There are 15 items, with total possible scores ranging from 0 to 26. Higher scores indicate more child media use. | Mean | Standard Deviation | units on a scale |
|
| OG001 | ROR plus text messages | In addition to ROR, participants will receive three text messages per week, plus one interactive follow-up message per month, for the study period with scheduled breaks. Usual care including ROR: Usual care which includes ROR. Text messages: 3 text messages per week and one interactive text per month. |
| OG002 | ROR plus text messages plus connection to community resources | In addition to ROR and text messages, participants will be referred to a county-based single point of entry system for referrals to community resources. This system simplifies access to poverty-reducing resources by creating a centralized access point, maintaining an updated data base of resources with existing capacity to support families, and providing case management. Usual care including ROR: Usual care which includes ROR. Text messages: 3 text messages per week and one interactive text per month. Connection to community resources: Referral to a non-profit that connects families with community resources and provides families with case management. |
|
|
|
| Primary | Child Communicative Skills | Caregiver report of non-verbal communication and early expressive language assessed using the MacArthur Bates Communicative Development Inventories. The Words & Gestures short form is an 89-word vocabulary checklist with separate columns for comprehension and production for children 8-18 months. The Words & Sentences versions contain a 100-word productive vocabulary checklist and a question about combining words for children 16-30 months. Scores are summed and higher scores denote stronger skills. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the MacArthur Bates Communicative Development Inventories at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | 9-month follow-up, 18-month follow-up |
|
|
|
|
| Primary | Child Social-emotional Skills | Child's social-emotional skills were assessed with the Devereux Early Childhood Assessment for Infants and Toddlers (DECA-I/T), which has 2 caregiver-report forms: an infant form (1-18 months) that includes Attachment/Relationships and Initiative subscales, and a toddler form (18-36 months) that includes Attachment/Relationships, Initiative, and Self-Regulation subscales. Scores are standardized on a T-distribution (M=50; SD=10). The Total Protective Factors score is calculated by adding subscale T-scores. T-scores of 60+ indicate an area strength, and T-scores of 40- indicate an area need. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the DECA at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | T-score | Baseline, 9-month follow-up, 18-month follow-up |
|
|
|
|
| Primary | Caregiver Cognitive Stimulation | The StimQ2 is a caregiver-reported measure of cognitive stimulation for children that includes domains on the home literacy environment (Reading scale) and responsiveness (Parental Verbal Responsiveness scale). The Reading scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the Reading scale range from 0 to 19. The Parental Verbal Responsiveness scale is composed of two subdimensions (Everyday Routines and Play and Pretend). Scores range from 0 to 15. Higher scores indicate more cognitive stimulation. The Reading scale was completed at baseline, the 9-month follow-up, and the 18-month follow-up. The Parent Verbal Responsiveness scale was completed at the 9-month follow-up and the18-month follow-up. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the StimQ2 at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9-month follow-up, 18-month follow-up |
|
|
|
|
| Primary | Dialogic Reading Behavior | The DialogPR is a caregiver report measure of shared reading quality. Score range from 0 to 30 with higher scores indicating more interactive reading. | Analyses for the 9-month visit include participants who had baseline data and completed the DialogPR at the 9-month visit. | Posted | Mean | Standard Deviation | score on a scale | 9-month follow-up |
|
|
|
|
| Primary | Caregiver Discipline Strategies | This questionnaire was modified from the National Survey of Early Childhood Health and asks two questions about verbal and physical discipline. Scores range from 0 to 6 and higher scores indicate harsher discipline strategies. | Analyses include participants who had baseline data and completed the caregiver discipline strategy measure at the 18-month follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 18-month follow-up |
|
|
|
|
| Secondary | Caregiver Attitudes About Reading | The Parent Reading Belief Inventory is a caregiver reported measure of attitudes about reading with children that included positive affect (scores range from 0 to 33). Higher scores indicate more favorable attitudes and greater knowledge. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the Parent Reading Belief Inventory (positive affect scale) at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | 9-month follow-up, 18-month follow-up |
|
|
|
|
| Secondary | Community Resource Participation | Community resource participation was measured via the Survey of Income and Program Participation (SIPP), a series of questions that asks about caregiver and child participation in different types of community resources (e.g. food/nutrition support, income support, childcare assistance, etc.). Possible scores range from 0 to 17, with higher scores indicating more involvement in community resources. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the SIPP at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9-month follow-up, 18-month follow-up |
|
|
|
|
| Secondary | Caregiver-clinician Relationship | The Physician-Parent Communication Survey is a caregiver reported measure of the caregiver-clinician relationship. We analyzed the interest subscale. The interest subscale includes 6 items are scored from 1 to 8. Scores from each item are averaged; thus total possible scores range from 1-8, with higher scores indicating stronger relationships. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the Physician-Parent Communication Survey at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 9-month follow-up, 18-month follow-up |
|
|
|
|
| Secondary | Social Needs and Stress | Caregiver report of social needs and stressors was assessed via the Local Inventory of Needs and Knowledge (LINK) survey. Caregivers rate statements on social needs and stress from 0 to 4 with higher scores indicating greater needs and stress. Possible scores range from 0 to 16 with higher scores indicating greater needs and economic stress. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the LINK at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9-month follow-up, 18-month follow-up |
|
|
|
|
| Secondary | Parent Stress | The Parental Stress Scale is an eighteen-item measure that assesses parental stress. Scores range from 18 to 90 with higher scores indicating greater stress. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the Parental Stress Scale at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9-month follow-up, 18-month follow-up |
|
|
|
|
| Secondary | Child Media Use | The ScreenQ is a caregiver report measure of media use in children. Scores range from 0 to 26 with higher score indicating more media use. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the ScreenQ at the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9-month follow-up, 18-month follow-up |
|
|
|
|
| Other Pre-specified | ROR Receipt | Caregiver's report of receipt of literacy promotion components during their previous healthcare visit. | Analyses for the 9-month and 18-month follow-up visits include participants who had baseline data and completed the 9-month and/or 18-month follow-up visit(s), respectively. Participants who did not participate in the 9-month follow-up were still welcome to participate in the 18-month follow-up. | Posted | Count of Participants | Participants | Baseline; 9-month follow up; 18-month follow up |
|
|
|
| Other Pre-specified | Observed Parent-child Interactions | Observation of parent-child interactions during shared reading and free play; observations will be coded based on DialogPR items | Not Posted | 9-month follow up | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | ROR plus text messages | In addition to ROR, participants will receive three text messages per week, plus one interactive follow-up message per month, for the study period with scheduled breaks. Usual care including ROR: Usual care which includes ROR. Text messages: 3 text messages per week and one interactive text per month. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | ROR plus text messages plus connection to community resources | In addition to ROR and text messages, participants will be referred to a county-based single point of entry system for referrals to community resources. This system simplifies access to poverty-reducing resources by creating a centralized access point, maintaining an updated data base of resources with existing capacity to support families, and providing case management. Usual care including ROR: Usual care which includes ROR. Text messages: 3 text messages per week and one interactive text per month. Connection to community resources: Referral to a non-profit that connects families with community resources and provides families with case management. | 0 | 0 | 0 | 0 | 0 | 0 |
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| 18-month follow-up |
|
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We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for child communicative development was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.
| Analysis for 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.82 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for child communicative development was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects. |
| Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.001 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for child communicative development was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects. |
| Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.16 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for child communicative development was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects. |
| 9-month follow-up |
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| 18-month follow-up |
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We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the social emotional domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=2 outcomes within the social emotional). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for social emotional development was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.
| Analysis for 9-month follow-up, A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.04 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the social emotional domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=2 outcomes within the social emotional). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for social emotional development was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects. |
| Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.08 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the social emotional domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=2 outcomes within the social emotional). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for social emotional development was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects. |
| Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.03 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the social emotional domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=2 outcomes within the social emotional). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for social emotional development was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects. |
| 9-month follow-up (Reading) |
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| 18-month follow-up (Reading) |
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| 9-month follow-up (Parent Verbal Responsiveness) |
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| 18-month follow-up (Parent Verbal Responsiveness) |
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We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for reading activities was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.
| Analysis for the Reading Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.80 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for reading activities was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects. |
| Analysis for the Reading Scale at the18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.79 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for reading activities was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects. |
| Analysis for the Reading Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.96 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for reading activities was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects. |
| Analysis for the Parent Verbal Responsiveness Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.22 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for verbal responsiveness was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects. |
| Analysis for the Parent Verbal Responsiveness Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | <0.001 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for verbal responsiveness was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects. |
| Analysis for the Parent Verbal Responsiveness Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.96 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for verbal responsiveness was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects. |
| Analysis for the Parent Verbal Responsiveness Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.12 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for verbal responsiveness was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects. |
We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. Dialogic reading behavior was measured at a single timepoint (9 months), so no adjustment was necessary.
| A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.96 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. Dialogic reading behavior was measured at a single timepoint (9 months), so no adjustment was necessary. |
We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. Discipline strategies were measured at a single timepoint (18 months), so no adjustment was necessary.
| A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.96 | p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p < 0.05 was used as an a priori threshold for statistical significance. | Superiority | We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. Discipline strategies were measured at a single timepoint (18 months), so no adjustment was necessary. |
| 18-month follow-up |
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Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. |
| ANOVA |
| 0.06 |
The a priori threshold for statistical significance was p < .05. |
| Superiority |
| Analysis at the 18-month follow-up. \A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.81 | The a priori threshold for statistical significance was p < .05. | Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.08 | The a priori threshold for statistical significance was p < .05. | Superiority |
| 9-month follow-up |
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| 18-month follow-up |
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Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. |
| ANOVA |
| 0.91 |
The a priori threshold for statistical significance was p < .05. |
| Superiority |
| Analysis at the18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.39 | The a priori threshold for statistical significance was p < .05. | Superiority |
| Analysis at the 18-month follow-up. \A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.10 | The a priori threshold for statistical significance was p < .05. | Superiority |
| 9-month follow-up |
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| 18-month follow-up |
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Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. |
| ANOVA |
| 0.18 |
The a priori threshold for statistical significance was p < .05. |
| Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.18 | The a priori threshold for statistical significance was p < .05. | Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.45 | The a priori threshold for statistical significance was p < .05. | Superiority |
| 9-month follow-up |
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| 18-month follow-up |
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Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. |
| ANOVA |
| 0.68 |
The a priori threshold for statistical significance was p < .05. |
| Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.16 | The a priori threshold for statistical significance was p < .05. | Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.39 | The a priori threshold for statistical significance was p < .05. | Superiority |
| 9-month follow-up |
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| 18-month follow-up |
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Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. |
| ANOVA |
| 0.14 |
The a priori threshold for statistical significance was p < .05. |
| Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.007 | The a priori threshold for statistical significance was p < .05. | Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.34 | The a priori threshold for statistical significance was p < .05. | Superiority |
| 9-month follow-up |
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| 18-month follow-up |
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Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. |
| ANOVA |
| 0.07 |
The a priori threshold for statistical significance was p < .05. |
| Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2. | ANOVA | 0.41 | The a priori threshold for statistical significance was p < .05. | Superiority |
| Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3. | ANOVA | 0.03 | The a priori threshold for statistical significance was p < .05. | Superiority |
| Baseline 1 component |
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| Baseline 2 components |
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| Baseline 3 components |
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| 9-month follow-up 0 componenets |
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| 9-month follow up 1 component |
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| 9-month follow-up 2 components |
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| 9-month follow-up 3 components |
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| 18-month follow-up 0 components |
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| 18-month follow-up 1 component |
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| 18-month follow-up 2 components |
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| 18-month follow-up 3 components |
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