Clinical trial NCT02724774: Collaborative Perinatal Mental Health and Parenting Support in Primary Care
Official title: Collaborative Perinatal Mental Health and Parenting Support in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Mother-child Relations
Keywords: infants
mental health
postpartum period
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-03-31
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Parent Sensitivity in Teaching
timeFrame: Baseline to infant age 12 months
measure: Change in Parent Sensitivity in Play
timeFrame: Baseline to infant age 12 months
measure: Change in Maternal Confidence
timeFrame: Baseline to infant age 12 months
measure: Change in Parent Understanding of Toddlers
timeFrame: Baseline to infant age 12 months
Secondary outcomes:
measure: Change in Infant Interactive Quality
timeFrame: Baseline to infant age 12 months
measure: Infant Behavioral Regulation: Externalizing T Score
timeFrame: infant age 12 months
measure: Infant Behavioral Regulation: Internalizing T Score
timeFrame: infant age 12 months
measure: Infant Behavioral Regulation: Dysregulation T Score
timeFrame: infant age 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Susan J Spieker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kelly, J., & Korfmacher, J. (2008). Raising a baby. University of Washington NCAST Publications.
citation: 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.
citation: 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.
citation: Crittenden, P. M. (1979-2010). CARE-Index: Infant Coding Manual. Family Relations Institute.
citation: 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.
citation: 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.