Families Together: Intervention for Reunified Families

April 1, 2026 updated by: Monica Oxford, University of Washington

Intervention to Improve Outcomes for Foster Children Reunited With Their Birth Families

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is no brief, home visiting, evidence-based intervention designed for and evaluated with Child Welfare System (CWS) birth parents and their children under six, once they are reunified. Why is this important? Because reunified birth parents represent one of the highest risk subpopulations of parents whose challenges contribute both to their child's exposure to stress and trauma and to the intergenerational transmission of impaired parenting, maltreatment, and foster care placement.

Reunified birth parents are more likely than other parents to have been foster children and survivors of childhood maltreatment. They have higher rates of co-morbid mental health disorders, substance abuse, poverty, low education, and homelessness. When their children are placed in out-of-home care as infants or toddlers, they are more likely to have longer stays in foster care than any other age group. Foster children are at risk for serious emotional, behavioral, neurological, and physiological health problems, and for continued relationship disruptions, maltreatment, and foster care placements throughout their life course. Birth parents need intervention services when they reunite with their child to support the already fragile parent-child relationship. Even when birth parents work hard to fulfill court requirements to regain custody of their child, they are often left without the skills necessary to establish a strong and lasting connection with their child. This failure of service, we believe, leads reunified families to experience a high rate of maltreatment reoccurrence and reentry into foster care.

In this application we will evaluate the effectiveness of a community based, home visiting intervention program with a population of birth parents recently reunified with their child under the age of six after a foster care placement. In order to do this, we first adapt the program by adding material relevant to reunified birth families and adapt the material for older children. We will evaluate the effectiveness of Promoting First Relationships ® (PFR; Kelly et al., 2008) to meet the parenting needs of this vulnerable population. Promoting First Relationships was originally designed for children birth to three, and we will expand the curriculum to meet the needs of children through age six. Through a strong, established community partnership between the state, a community mental health agency, and the University of Washington, we will 1) adapt Promoting First Relationships ® (PFR) for reunified birth families and older children; 2) test the effectiveness of PFR to improve parental quality and parent-child interaction as compared to a Resource and Referral service; 3) test the effectiveness of PFR on reducing social, emotional, and behavioral problems in a population of children at risk for elevated emotional and behavioral disorders; 4) test the effectiveness of PFR in reducing referrals to Child Protective Services (CPS) and re-entry into foster care.

Participants complete baseline assessments during an observation-only period. The parent-child dyad is randomized following the baseline assessment. They then receive the study intervention for 7-43 weeks, after which no further intervention is delivered. Outcome assessments are conducted during the post-intervention follow-up period immediately after completion of the intervention and again 6 months later. Outcome assessments are obtained (if possible) even when the intervention is not completed, for intent-to-treat analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington, Child, Family, and Population Health Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Promoting First Relationships
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 ®
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.
Other Names:
  • PFR
Other: Resource & Referral
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
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.
Other Names:
  • R&R

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Welfare Services Removal From Birth Parent Home
Time Frame: 18 months post enrollment in the study
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)
Time Frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
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)
Time Frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
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
Time Frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
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
Time Frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Child Externalizing Problem Behavior
Time Frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Child externalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach & Rescorla, 2000). The externalizing scale has 24 items; raw scores can range from 0 to 48 with higher scores indicating more externalizing behaviors.
Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Child Externalizing Problem Behavior
Time Frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Child externalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach & Rescorla, 2000). The externalizing scale has 24 items; raw scores can range from 0 to 48 with higher scores indicating more externalizing behaviors.
6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Change in Child Internalizing Problem Behavior
Time Frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Child internalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach & Rescorla, 2000). The internalizing scale has 36 items; raw scores can range from 0 to 72 with higher scores indicating more internalizing behaviors.
Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Child Internalizing Problem Behavior
Time Frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Child internalizing behavioral problems will be measured based on parent report using the Child Behavior Check List (CBCL: Achenbach & Rescorla, 2000). The internalizing scale has 36 items; raw scores can range from 0 to 72 with higher scores indicating more internalizing behaviors.
6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Monica L Oxford, MSW, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D-110816-S
  • R01HD090176 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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