Collaborative Perinatal Mental Health and Parenting Support in Primary Care

NCT02724774 | Completed Results

• 2 other identifiers: STUDY00010114R01HD080851
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Mother-child Relations

Keywords

infants; mental health; postpartum period

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Change in Infant Interactive Quality

  Baseline to infant age 12 months

• Infant Behavioral Regulation: Externalizing T Score

  infant age 12 months

• Infant Behavioral Regulation: Internalizing T Score

  infant age 12 months

• Infant Behavioral Regulation: Dysregulation T Score

  infant age 12 months

Study Arms (2)

Promoting First Relationships® (PFR)

EXPERIMENTAL

10 week home visiting program

Behavioral: Promoting First Relationships®

Parent Information Packet

NO INTERVENTION

A packet is mailed to the families, including handouts related to child development, health, and local resources.

Interventions

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.

Also known as: PFR

Promoting First Relationships® (PFR)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195-7920, United States

Location

Related 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.

  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.

  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.

  PMID: 1891613 BACKGROUND

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

  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.

  PMID: 14561058 BACKGROUND

• 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.

  PMID: 34591567 RESULT

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Results Point of Contact

• Title: Carol Rhodes, Director of Sponsored Programs
• Organization: University of Washington

carhodes@uw.edu

206 543-2139

Study Officials

• Susan J Spieker, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 31, 2016
• Study Start: November 24, 2015
• Primary Completion: April 4, 2020
• Study Completion: April 4, 2020
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)