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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD086894-01A1 | 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 |
| Oregon Research Institute | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
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A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes
To address the life course needs of depressed mothers and their infants, brief, accessible, and integrated interventions that target both maternal depression and specific nurturing parent behaviors demonstrated to improve infant social-emotional communication outcomes are needed. In prior programmatic research, two separate web-based, remote coaching interventions for: (a) parent nurturing behaviors that improve infant outcomes (Baby-Net R34; R01) [13], and (b) maternal depression (Mom-Net R34; R01) [14] were developed. Compared to controls, the Baby-Net program demonstrated medium to large effects on observed nurturing parent behavior and on infant social-emotional competencies in the context of play [13] and in the context of book activities [15]. Mom-Net demonstrated low attrition and high levels of feasibility, program use, and satisfaction [14]. Compared to controls, Mom-Net participants demonstrated significant reductions in depression and improved preschool parenting behavior [14]. A substantial advantage of the mobile, remote coaching approach is that it overcomes multiple logistical barriers that often prevent low-income mothers from participating in community/home visiting treatment programs [2]. Thus, this prior research on web-based maternal depression and specific nurturing parenting behavior in infancy, provides a strong empirical basis for the Mom & Baby Net program. Investigators will rigorously test the merged Mom & Baby Net intervention effects with a total sample of 368 participants (184 mothers with depression and 184 infants) via a 2-arm, intent-to-treat, randomized controlled trial.
The start date of this grant-funded randomized controlled trial was September 1, 2016. Data collection is currently underway and scheduled to conclude in March 2022. Following IRB-approved pilot work, the randomized controlled trial was IRB- approved on November 17, 2017. Immediately following IRB approval, recruitment was initiated. Between February 15, 2018 and March 11, 2021, we successfully consented a total sample of 368 participants (184 women and 184 infants) into the randomized controlled trial. The sample is predominantly Black and socioeconomically disadvantaged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mom & Baby Net | Experimental | CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral |
|
| Depression & Developmental Awareness System | Active Comparator | Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mom & Baby Net | Behavioral | CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral |
| Measure | Description | Time Frame |
|---|---|---|
| PHQ9 | Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| Landry Parent Child Interaction Rating Scales - Mother Positive Behavior | Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: mother positive behavior (values = 4-20; higher scores = better outcomes); | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| Landry Parent Child Interaction Rating Scales - Mother Negative Behavior | Dichotomized rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: mother negative behavior (values = 0-1; higher scores = worse outcomes) | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior | Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: child positive/engagement behavior (values = 2-10; higher scores = better outcomes) | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend | Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Maintain/Extend (values = 0-100%; higher = better outcomes); |
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Inclusion Criteria:
Exclusion Criteria:
Stressors that mother specifies at the time of screening that would interfere with study participation such as: maternal homelessness, mental or physical health condition (diagnosed with schizophrenia or treatment/medication for hallucinations/delusions), current inpatient treatment for mental health or substance abuse. Infant exclusion criteria include factors that could render research participation stressful, such as intensive treatment for a genetic or health condition or not in permanent legal guardian custody
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Baggett, PhD | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30302 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34456828 | Background | Baggett KM, Davis B, Mosley EA, Miller K, Leve C, Feil EG. Depressed and Socioeconomically Disadvantaged Mothers' Progression Into a Randomized Controlled Mobile Mental Health and Parenting Intervention: A Descriptive Examination Prior to and During COVID-19. Front Psychol. 2021 Aug 12;12:719149. doi: 10.3389/fpsyg.2021.719149. eCollection 2021. | |
| 33276610 | Background | Baggett KM, Davis B, Sheeber LB, Ammerman RT, Mosley EA, Miller K, Feil EG. Minding the Gatekeepers: Referral and Recruitment of Postpartum Mothers with Depression into a Randomized Controlled Trial of a Mobile Internet Parenting Intervention to Improve Mood and Optimize Infant Social Communication Outcomes. Int J Environ Res Public Health. 2020 Dec 2;17(23):8978. doi: 10.3390/ijerph17238978. |
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Participant flow shows 368 total participants enrolled, which matches the Protocol section documenting 368 total participants enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Mom & Baby Net | CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral Mom & Baby Net: CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral |
| FG001 | Depression & Developmental Awareness System | Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) Depression & Developmental Awareness System: Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participant dyads (mothers and infants) who consented and completed pre-assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | Mom & Baby Net | CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral Mom & Baby Net: CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age for one participant dyad is unknown |
| 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 | PHQ9 | Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome | Discrepancy between Participant Flow and analyzed number is due to missing data for analysis | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
|
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
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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 | Mom & Baby Net Mothers | CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral Mom & Baby Net: CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Baggett | Georgia State University | 404-413-1571 | kbaggett@gsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Nov 15, 2018 | Jan 29, 2024 | Prot_ICF_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2016 | Jun 15, 2022 | SAP_001.pdf |
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Two arm, randomized controlled intent to treat trial
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Assessment coders and participants are naive to treatment condition
| Depression & Developmental Awareness System | Behavioral | Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) |
|
| Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive | Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Overall Positive (values = 0-100%; higher = better outcomes) | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| Indicator of Parent Child Interaction (IPCI) - Child Positive Social | Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Positive Social (values = 0-100%; higher = better outcomes); | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| Indicator of Parent Child Interaction (IPCI) - Child Engagement | Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Engagement (values = 0-100%; higher = better outcomes) | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| Knowledge of Infant Social-Emotional Development and Promotion | Rating scale used to assess understanding of the concepts of infant social-emotional behavior and its promotion by caregivers, assessing both definitional and applied concept knowledge; values = 0-28 higher scores = better outcomes | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
| 34406122 | Background | Baggett KM, Davis B, Sheeber L, Miller K, Leve C, Mosley EA, Landry SH, Feil EG. Optimizing Social-Emotional-Communication Development in Infants of Mothers With Depression: Protocol for a Randomized Controlled Trial of a Mobile Intervention Targeting Depression and Responsive Parenting. JMIR Res Protoc. 2021 Aug 18;10(8):e31072. doi: 10.2196/31072. |
| Passive Disengagement |
|
| BG001 | Depression & Developmental Awareness System | Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) Depression & Developmental Awareness System: Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Age for one participant dyad is unknown. Mother and infant age are reported separately - infant age is reported in years and not months since we are unable to indicate two units of measure. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | One participant did not report their infant's gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity for one mother/infant dyad was not reported | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race for some mothers and infants was not reported | Count of Participants | Participants |
|
| Region of Enrollment | Region of Enrollment for Mother participants | Analysis includes mother participants only | Number | participants |
|
| Region of Enrollment | Region of Enrollment for Infant participants | Analysis includes infant participants only | Number | participants |
|
| OG001 | Depression & Developmental Awareness System | Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) Depression & Developmental Awareness System: Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) |
|
|
|
| Primary | Landry Parent Child Interaction Rating Scales - Mother Positive Behavior | Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: mother positive behavior (values = 4-20; higher scores = better outcomes); | Numbers analyzed differ due to missing data | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
|
|
|
|
| Primary | Landry Parent Child Interaction Rating Scales - Mother Negative Behavior | Dichotomized rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: mother negative behavior (values = 0-1; higher scores = worse outcomes) | Numbers analyzed differ due to missing data | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
|
|
|
|
| Primary | Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior | Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include: child positive/engagement behavior (values = 2-10; higher scores = better outcomes) | Numbers analyzed differ due to missing data | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
|
|
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|
| Primary | Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend | Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Maintain/Extend (values = 0-100%; higher = better outcomes); | Number analyzed differs due to missing data | Posted | Mean | Standard Deviation | percentage of occurrence | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
|
|
|
|
| Primary | Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive | Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Overall Positive (values = 0-100%; higher = better outcomes) | Number analyzed differs due to missing data | Posted | Mean | Standard Deviation | percentage of occurrence | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
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| Primary | Indicator of Parent Child Interaction (IPCI) - Child Positive Social | Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Positive Social (values = 0-100%; higher = better outcomes); | Number analyzed differs due to missing data | Posted | Mean | Standard Deviation | percentage of occurrence | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
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| Primary | Indicator of Parent Child Interaction (IPCI) - Child Engagement | Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Engagement (values = 0-100%; higher = better outcomes) | Number analyzed differs due to missing data | Posted | Mean | Standard Deviation | percentage of occurrence | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
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|
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| Primary | Knowledge of Infant Social-Emotional Development and Promotion | Rating scale used to assess understanding of the concepts of infant social-emotional behavior and its promotion by caregivers, assessing both definitional and applied concept knowledge; values = 0-28 higher scores = better outcomes | Discrepancy between Participant Flow and analyzed number is due to missing data for analysis | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention) |
|
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Depression & Developmental Awareness System Mothers | Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) Depression & Developmental Awareness System: Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) | 0 | 92 | 0 | 92 | 0 | 92 |
| EG002 | Mom & Baby Net Infants | CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral Mom & Baby Net: CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral | 0 | 92 | 0 | 92 | 0 | 92 |
| EG003 | Depression & Developmental Awareness System Infants | Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) Depression & Developmental Awareness System: Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) | 0 | 92 | 0 | 92 | 0 | 92 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Post-Intervention |
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| Post-Intervention |
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| Post-Intervention |
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| Post-intervention |
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| Post-intervention |
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| Post-intervention |
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| Post-intervention |
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