Collaborative Perinatal Mental Health and Parenting Support in Primary Care

Parenting Clinical Trial

Official title:

Collaborative Perinatal Mental Health and Parenting Support in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724774
• Other study ID #: STUDY00010114
• Secondary ID: R01HD080851
• Status: Completed
• Phase: N/A
• Start date: November 24, 2015
• Est. completion date: April 4, 2020

Study information

• Verified date: November 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: April 4, 2020
• Est. primary completion date: April 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mothers with infants 6 weeks - 3 months old
• English or Spanish speaking
• Access to a telephone
• Currently or at some point during pregnancy received treatment for a mental health condition (counseling and/or medications) at a participating community health center in the Seattle, Washington area

Exclusion Criteria:

• Currently experiencing an acute crisis (e.g., severe domestic violence, homelessness, hospitalization, imprisonment)

Related Conditions & MeSH terms

• Mother-child Relations
• Parenting

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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.

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. — View Citation

Crittenden, P. M. (1979-2010). CARE-Index: Infant Coding Manual. Family Relations Institute.

Kelly, J., & Korfmacher, J. (2008). Raising a baby. University of Washington NCAST Publications.

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.

Oxford ML, Hash JB, Lohr MJ, Bleil ME, Fleming CB, Unützer 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/dev — View Citation

Zahr LK. The relationship between maternal confidence and mother-infant behaviors in premature infants. Res Nurs Health. 1991 Aug;14(4):279-86. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to infant age 12 months
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.]	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.	Baseline to infant age 12 months
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.	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).	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.	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.	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.	infant age 12 months