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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD080851 | 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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Treating mothers' perinatal depressive and other mental health symptoms alone does not prevent impaired parenting quality and adverse infant outcomes. The goal of this research is to conduct a randomized controlled trial to evaluate the effectiveness of adding a research-based 10-week home visiting parenting program to evidence-based mental health treatment, to counter the pernicious effects of mothers' symptoms on parenting quality and infant development. Participants will be English and Spanish-speaking low-income mothers who began publicly funded mental/behavioral health treatment in pregnancy at their primary care community health centers.
Infants exposed to impaired parenting as a result of their mothers' major depression and other mental health disorders in the perinatal period are at risk for compromised social interaction and affective and behavioral regulation. Depression is the most frequently reported mental health condition during the perinatal period; about 9% of infants under one year have mothers who experience a major depressive episode. That rate nearly triples to 25% for infants of mothers below 200% of the federal poverty level. In addition to poverty, young maternal age, lack of social support, low education, and adverse childhood experiences are all risk factors for depression, anxiety, and other mental health conditions. Two strands of research point to the need for effective parenting support for mothers following treatment for mental health conditions in pregnancy. First, depressed mothers frequently fail to accurately notice, interpret, or respond sensitively to infant cues. Alarmingly, mothers' impaired parenting of their infants continues even after their depression has been successfully treated. Second, newborns of prenatally depressed women are physiologically dysregulated and hence more challenging to nurture. With the passage of the Affordable Care Act and Maternal, Infant, and Early Childhood Home Visiting, the federal government is supporting states to implement high-quality home visiting programs as part of a comprehensive early childhood system for vulnerable families experiencing the risk factors associated with maternal depression and other mental health symptoms. But two important limitations of home visiting have been identified: child development home visitors are not trained to deal meaningfully with maternal depression and other mental health conditions, and they are often not sufficiently trained to support infant-mother relationships. Our study has the potential to inform intervention programs nationwide by testing the effectiveness of adding a short, attachment-based, home-visiting parenting program to an existing, evidence-based mental health treatment program delivered via community primary care clinics serving pregnant and parenting women from vulnerable populations. The goal of this research is to conduct a randomized controlled trial to evaluate the effectiveness of Promoting First Relationships® for English and Spanish-speaking low-income mothers who were treated for depression or other mental health conditions beginning in pregnancy and as needed in the perinatal year. Treatment will be coordinated through the publicly funded, evidenced-based Mental Health Integration Program for High-Risk Pregnant and Parenting Women (MHIP Moms) in primary care community health centers that target safety-net populations in King County, Washington. Promoting First Relationships® is a research-based, 10-week home visiting program that uses video feedback and strengths-based consultation strategies to increase mothers' parenting competence and confidence. Bilingual community providers will deliver Promoting First Relationships® after a baseline assessment and random assignment at infant age three months. Post tests will occur at infant age six and twelve months. The primary specific aims are to test the effectiveness of PFR to improve parenting quality for low income, English and Spanish speaking mothers who began mental/behavioral health treatment during pregnancy, and to improve social and regulatory outcomes for their infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promoting First Relationships® (PFR) | Experimental | 10 week home visiting program |
|
| Parent Information Packet | No Intervention | A packet is mailed to the families, including handouts related to child development, health, and local resources. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promoting First Relationships® | Behavioral | PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parent Sensitivity in Teaching | Nursing Child Assessment Teaching Scale: coded from observation of mother interacting with the infant during teaching task. The parenting sensitivity score can range from 0 to 50; higher scores indicate greater sensitivity. | Baseline to infant age 12 months |
| Change in Parent Sensitivity in Play | Child-Adult Relationship Experimental-Index (CARE-Index): coded from observation of mother and infant in free play activity. Dyadic synchrony and maternal sensitivity scores can range from 0 to 14, with higher scores indicating more positive interactions. [Because maternal sensitivity and dyadic synchrony are correlated .98-.99, only dyadic synchrony will be reported.] | Baseline to infant age 12 months |
| Change in Maternal Confidence | Maternal Confidence Questionnaire (MCQ; Zahr, 1991): 14-item self report measure rated on a 5-point frequency scale. The mean score can range from 1 to 5, with higher scores indicating greater maternal confidence. | Baseline to infant age 12 months |
| Change in Parent Understanding of Toddlers | Raising a Baby Scale: 16-item self-report measure rated on a 4-point agree/disagree scale. The scores can range from 16 to 64, with higher scores indicating greater parental knowledge. | Baseline to infant age 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infant Interactive Quality | CARE-Index: coded from observation of mother and infant in free play activity. Child cooperation scores can range from 0 to 14, with higher scores indicating more positive interactions. (Because child cooperation and dyadic synchrony are correlated .95-.96, a different CARE-Index scale with lower correlations with dyadic synchrony (-.32 to .05), child difficultness, will be used). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan J Spieker, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195-7920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Barnard, K. E. (1994). What the Teaching Scale measures. In G. S. Sumner & A. Spietz (Eds.), NCAST: Caregiver/parent-child interaction teaching manual. University of Washington NCAST Publications. | ||
| Background | Kelly, J., & Korfmacher, J. (2008). Raising a baby. University of Washington NCAST Publications. | ||
| Background | Kelly, J., Sandoval, D., Zuckerman, T. G., & Buehlman, K. (2008). Promoting First Relationships: A program for service providers to help parents and other caregivers nurture young children's social and emotional development (2 ed.). University of Washington NCAST Programs. | ||
| 1891613 | Background | Zahr LK. The relationship between maternal confidence and mother-infant behaviors in premature infants. Res Nurs Health. 1991 Aug;14(4):279-86. doi: 10.1002/nur.4770140406. |
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599 cases were screened for eligibility. 353 were determined eligible and contacted about the study 101 declined (74 not interested; 20 unreachable; 7 could not be enrolled because at that time there was no space in the program). 252 were seen in the baseline visit and randomized.
Recruitment was conducted in collaboration with the Mental Health Integration Program (MHIP) and Maternity Support Services (MSS) of Public Health Seattle and King County, Washington. Five community health clinics offering MHIP agreed to assist in study recruitment. Eligible participants received mental health treatment during pregnancy, spoke English or Spanish, had an infant under three months, had a telephone, and were planning to remain in the study area until the child's first birthday.
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| ID | Title | Description |
|---|---|---|
| FG000 | Promoting First Relationships® (PFR) | 10 week home visiting program Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting. |
| FG001 | Parent Information Packet | A packet is mailed to the families, including handouts related to child development, health, and local resources. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Mother-infant dyads were recruited and randomized in pairs.
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| ID | Title | Description |
|---|---|---|
| BG000 | Promoting First Relationships® (PFR) | 10 week home visiting program Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Each arm consisted of dyads of mother-infant pairs. |
| 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 | Change in Parent Sensitivity in Teaching | Nursing Child Assessment Teaching Scale: coded from observation of mother interacting with the infant during teaching task. The parenting sensitivity score can range from 0 to 50; higher scores indicate greater sensitivity. | Posted | Mean | Standard Deviation | score on a scale | Baseline to infant age 12 months |
|
12 months
Both groups received positive services and no physical/medical 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 | Promoting First Relationships® (PFR) | 10 week home visiting program Promoting First Relationships®: PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol Rhodes, Director of Sponsored Programs | University of Washington | 206 543-2139 | carhodes@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2021 | Nov 17, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2021 | Nov 17, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 21, 2016 | Nov 17, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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|
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| Baseline to infant age 12 months |
| Infant Behavioral Regulation: Externalizing T Score | Infant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems. | infant age 12 months |
| Infant Behavioral Regulation: Internalizing T Score | Infant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems. | infant age 12 months |
| Infant Behavioral Regulation: Dysregulation T Score | Infant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems. | infant age 12 months |
| Background | Crittenden, P. M. (1979-2010). CARE-Index: Infant Coding Manual. Family Relations Institute. |
| 14561058 | Background | Carter AS, Briggs-Gowan MJ, Jones SM, Little TD. The Infant-Toddler Social and Emotional Assessment (ITSEA): factor structure, reliability, and validity. J Abnorm Child Psychol. 2003 Oct;31(5):495-514. doi: 10.1023/a:1025449031360. |
| 34591567 | Result | Oxford ML, Hash JB, Lohr MJ, Bleil ME, Fleming CB, Unutzer J, Spieker SJ. Randomized trial of promoting first relationships for new mothers who received community mental health services in pregnancy. Dev Psychol. 2021 Aug;57(8):1228-1241. doi: 10.1037/dev0001219. |
| 42288803 | Derived | Hash JB, Nelson DC, Fleming CB, Oxford ML, Lohr MJ, de Castro AB, Bleil ME, Spieker SJ. Expanded adverse childhood experiences and postpartum mental health among an under-resourced sample of Spanish- and English-speaking mothers referred for community-based mental health services during pregnancy. BMC Pregnancy Childbirth. 2026 Jun 13. doi: 10.1186/s12884-026-09401-w. Online ahead of print. |
| 42017170 | Derived | Hash JB, Oxford ML, Nelson DC, Lohr MJ, Fleming CB, de Castro AB, Spieker SJ. Efficacy of Promoting First Relationships(R) for English and Spanish Speakers: A Randomized Controlled Trial. J Fam Stud. 2025 May;34(5):1135-1150. doi: 10.1007/s10826-024-03003-w. Epub 2025 May 7. |
| BG001 | Parent Information Packet | A packet is mailed to the families, including handouts related to child development, health, and local resources. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mother's age is in years. | The full sample consists of 252 mothers and 252 infants, or 504 individuals. Mother-infant dyads were randomized in pairs, 127 to PFR, 125 to the control arm. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | There were 504 study participants consisting of 252 mother-infant dyads. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Data are reported in dyads consisting of mother-infant pairs | Number | participants |
|
| NCATS Parenting Sensitivity | Nursing Child Assessment Teaching Scale: coded from observation of mother interacting with infant during teaching task (NCATS; Barnard, 1994). The parenting sensitivity score can range from 0 to 50; higher scores indicate greater sensitivity. | Missing data | Mean | Standard Deviation | units on a scale |
|
| Sensitivity in Play-Dyadic Synchrony | Child-Adult Relationship Experimental-Index (CARE-Index): coded from observation of mother and infant in free play activity (Crittenden, 1979-2005). Dyadic synchrony and maternal sensitivity scores can range from 0 to 14, with higher scores indicating more positive interactions. [Because maternal sensitivity and dyadic synchrony are correlated .98-.99, only dyadic synchrony will be reported.] | Missing data | Mean | Standard Deviation | units on a scale |
|
| Parent Understanding of Toddlers | Raising a Baby Scale (Kelly, Korfmacher, & Buehlman, 2008): 16-item self report measure rated on a 4-point agree/disagree scale. The scores can range from 16 to 64, with higher scores indicating greater parental knowledge. | Missing data | Mean | Standard Deviation | units on a scale |
|
| Maternal Confidence | Maternal Confidence Questionnaire (MCQ; Zahr, 1991): 14-item self report measure rated on a 5-point frequency scale. The mean score can range from 1 to 5, with higher scores indicating greater maternal confidence. | Mean | Standard Deviation | units on a scale |
|
| Infant Interactive Quality-Difficultness | CARE-Index: coded from observation of mother and infant in free play activity (Crittenden, 1979-2005). Child cooperation scores can range from 0 to 14, with higher scores indicating more positive interactions. (Because child cooperation and dyadic synchrony are correlated .95-.96, a different CARE-Index scale with lower correlations with dyadic synchrony (-.32 to .05), child difficultness, will be used). | Missing data | Mean | Standard Deviation | units on a scale |
|
| OG001 | Parent Information Packet | A packet is mailed to the families, including handouts related to child development, health, and local resources. |
|
|
|
| Primary | Change in Parent Sensitivity in Play | Child-Adult Relationship Experimental-Index (CARE-Index): coded from observation of mother and infant in free play activity. Dyadic synchrony and maternal sensitivity scores can range from 0 to 14, with higher scores indicating more positive interactions. [Because maternal sensitivity and dyadic synchrony are correlated .98-.99, only dyadic synchrony will be reported.] | Posted | Mean | Standard Deviation | units on a scale | Baseline to infant age 12 months |
|
|
|
|
| Primary | Change in Maternal Confidence | Maternal Confidence Questionnaire (MCQ; Zahr, 1991): 14-item self report measure rated on a 5-point frequency scale. The mean score can range from 1 to 5, with higher scores indicating greater maternal confidence. | Posted | Mean | Standard Deviation | score on a scale | Baseline to infant age 12 months |
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|
|
|
| Primary | Change in Parent Understanding of Toddlers | Raising a Baby Scale: 16-item self-report measure rated on a 4-point agree/disagree scale. The scores can range from 16 to 64, with higher scores indicating greater parental knowledge. | Posted | Mean | Standard Deviation | score on a scale | Baseline to infant age 12 months |
|
|
|
|
| Secondary | Change in Infant Interactive Quality | CARE-Index: coded from observation of mother and infant in free play activity. Child cooperation scores can range from 0 to 14, with higher scores indicating more positive interactions. (Because child cooperation and dyadic synchrony are correlated .95-.96, a different CARE-Index scale with lower correlations with dyadic synchrony (-.32 to .05), child difficultness, will be used). | Posted | Mean | Standard Deviation | units on a scale | Baseline to infant age 12 months |
|
|
|
|
| Secondary | Infant Behavioral Regulation: Externalizing T Score | Infant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems. | Posted | Mean | Standard Deviation | score on a scale | infant age 12 months |
|
|
|
|
| Secondary | Infant Behavioral Regulation: Internalizing T Score | Infant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems. | Posted | Mean | Standard Deviation | score on a scale | infant age 12 months |
|
|
|
|
| Secondary | Infant Behavioral Regulation: Dysregulation T Score | Infant Toddler Social Emotional Assessment: maternal report of child internalizing, externalizing, and dysregulation problem behaviors. T scores can range from 20 to 99, with higher scores indicating more behavior problems. | Posted | Mean | Standard Deviation | score on a scale | infant age 12 months |
|
|
|
|
| 0 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | Parent Information Packet | A packet is mailed to the families, including handouts related to child development, health, and local resources. | 0 | 125 | 0 | 125 | 0 | 125 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|
| 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 |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|