Families Together: Intervention for Reunified Families

NCT04382677 | Completed Results DMC

• 2 other identifiers: D-110816-SR01HD090176
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Birth parents of young children who have been placed into foster care are a highly vulnerable population of caregivers. Little is known about the ability of existing prevention programs to intervene with birth parents who have recently been reunified with their children under the age of six. This project aims to evaluate a brief, home-visiting intervention model with a sample of reunified birth parents, examining its effectiveness to improve parenting and child wellbeing, and reduce reoccurrence of maltreatment and reunification failure.

Conditions

Child Abuse; Child Neglect

Keywords

Child Welfare; Child Protective Services; Parenting; Child maltreatment

Outcome Measures

Primary Outcomes (5)

• Child Welfare Services Removal From Birth Parent Home

  Official child welfare administrative records indicating whether the child in they dyad was removed from the birth parent home. 18 months post enrollment is approximately 1 year post intervention for those who completed interventions on schedule

  18 months post enrollment in the study

• Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)

  Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.

  Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)

• Change in Parental Sensitivity (Video Recorded Observations Coded by Coders Blind to Intervention)

  Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The score is the sum of 37 items, ranging from 0 to 37; higher scores indicate greater parental sensitivity.

  6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

• Change in Parenting Knowledge of Child Development

  14-item Likert-scale questionnaire developed by the study, "Raising a Child," is a measure of caregivers' knowledge of children's social-emotional needs and developmentally appropriate expectations. Items are scored on a scale ranging from 1 to 4 points. The Raising a Child scale score is the sum of the 14 items; the range is 14 to 56 with higher scores indicating greater parenting knowledge (better outcome).

  Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)

• Change in Parenting Knowledge of Child Development

  14-item Likert-scale questionnaire developed by the study, "Raising a Child," is a measure of caregivers' knowledge of children's social-emotional needs and developmentally appropriate expectations. Items are scored on a scale ranging from 1 to 4 points. The Raising a Child scale score is the sum of the 14 items; the range is 14 to 56 with higher scores indicating greater parenting knowledge (better outcome).

  6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

Secondary Outcomes (4)

• Change in Child Externalizing Problem Behavior

  Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)

• Change in Child Externalizing Problem Behavior

  6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

• Change in Child Internalizing Problem Behavior

  Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)

• Change in Child Internalizing Problem Behavior

  6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

Study Arms (2)

Promoting First Relationships

EXPERIMENTAL

The PFR program designed for birth families being reunited after foster care placement consists of a manualized 12-session intervention delivered in the home by trained providers.

Behavioral: Promoting First Relationships ®

Resource & Referral

OTHER

The service consists of a needs assessment conducted by phone, followed by a personalized resource packet and referrals, and 3 monthly check-in phone calls.

Other: Resource & Referral

Interventions

Promoting First Relationships ® BEHAVIORAL

Promoting First Relationships ® is based on attachment theory and is strengths-based. The 12 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 their concerns, and establishing a positive, supportive relationship. The provider videotapes playtime between parent and child, and alternates weeks watching the video with the parent, reflecting about the needs of both parent and child (reflective observation). PFR consultation strategies include Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts. These core strategies enhance parents' sense of security and competency. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify their own feelings and needs around parenting.

Also known as: PFR

Promoting First Relationships

Resource & Referral OTHER

This condition consists of 1) Resource \& Referral assistance provided over the phone, and 2) Local Services Resource Packet. Throughout the intervention period, the provider makes monthly phone calls to offer further support to families, answer questions, and provide additional resources. The provider has at least four interactions with each family served. In addition, families in this condition have the Resource and Referral Specialist's phone number and they can call if an additional need arises. The resource packet includes local information organized by type of need or resource. These packets are updated regularly as services change over time.

Also known as: R&R

Resource & Referral

Eligibility Criteria

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

You may qualify if:

• Birth parents reunited with their child (age 1-5 years) after a foster or kin care placement in trial return home status
• Parenting the child at study enrollment
• Child Welfare case served by the following Washington State offices: all of Region 2 South, Lynnwood, Tacoma, Everett, Smokey Point, and Lakewood
• Birth parents must be age 18 or older, mothers and fathers are eligible (one parent per study child enrolled)
• Conversant in English
• Access to a telephone
• Housing situation allows for home visits

You may not qualify if:

• Experiencing an acute crisis (e.g., hospitalization, incarceration)
• Previously received the Promoting First Relationships ® intervention or Child Parent Psychotherapy (CPP)

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, Child, Family, and Population Health Nursing

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

Health Resources; Referral and Consultation

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Professional Practice; Organization and Administration; Health Services Administration

Limitations and Caveats

Factors that may have contributed to the results of this study: Families were highly stressed, had few resources, and had many unmet basic needs, were affected by the COVID pandemic. Missing observational data due to the pandemic is a limitation as were unexpected low alpha reliabilities of the observational measure. The study took place during the synthetic opioid crisis and during changes in WA State child removal criteria in child welfare.

Results Point of Contact

• Title: Monica L. Oxford, Executive Director, Barnard Center for Infant and Early Childhood Mental Health
• Organization: University of Washington

mloxford@uw.edu

206-685-6107

Study Officials

• Monica L Oxford, MSW, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 11, 2020
• Study Start: December 20, 2017
• Primary Completion: May 27, 2024
• Study Completion: January 31, 2025
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)