An interventional study of Promoting First Relationships ® and Resource & Referral in Child Abuse and Child Neglect, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 ®
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
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
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Change in Child Externalizing Problem Behavior
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.
Time frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Child Externalizing Problem Behavior
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.
Time frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Change in Child Internalizing Problem Behavior
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.
Time frame: Post intervention (Time 2) -- approximately 6 months after Baseline (Time 1)
Change in Child Internalizing Problem Behavior
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.
Time frame: 6 months post intervention (Time 3) -- approximately 12 months after Baseline (Time 1)
Recruitment took place between 12/2017 and 5/2023 in collaboration with the Washington State Department of Children, Youth, \& Families (DCYF). A DCYF study liaison mailed opt-out letters to birth parents recently reunified with a child aged 1-5 years after a foster care placement (open case in Trial Return Home status), living in the greater Seattle, WA area. Parents who did not opt out were contacted by a study recruiter, screened for eligibility, and enrolled in the study.
| Milestone | Promoting First Relationships | Resource & Referral |
|---|---|---|
| Started | 132 | 132 |
| Completed | 132 | 132 |
| Not completed | 0 | 0 |
| Milestone | Promoting First Relationships | Resource & Referral |
|---|---|---|
| Started | 109 | 127 |
| Completed | 68 | 104 |
| Not completed | 41 | 23 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Busy, competing demands | 19 | 0 |
| Withdrew: Lost to follow-up | 10 | 4 |
| Withdrew: Became ineligible-out of area, not parenting | 4 | 5 |
| Withdrew: Dropped due to covid-19 pause | 6 | 13 |
| Milestone | Promoting First Relationships | Resource & Referral |
|---|---|---|
| Started | 118 | 117 |
| Completed | 93 | 98 |
| Not completed | 25 | 19 |
| Withdrew: Lost to follow-up | 18 | 9 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Became ineligible-not parenting | 7 | 8 |
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
| Participants | Promoting First Relationships | Resource & Referral |
|---|---|---|
| Child Welfare Services Removal From Birth Parent Home | 12 | 19 |
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.
| scores on a scale | Resource & Referral | Promoting First Relationships |
|---|---|---|
| Baseline | 27.82 ± 3.56 | 27.91 ± 3.70 |
| Post-intervention follow-up | 28.44 ± 3.59 | 28.05 ± 3.36 |
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.
| scores on a scale | Resource & Referral | Promoting First Relationships |
|---|---|---|
| Baseline | 27.82 ± 3.56 | 27.91 ± 3.70 |
| 6-month follow-up | 28.32 ± 3.45 | 27.94 ± 3.21 |
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).
| scores on a scale | Resource & Referral | Promoting First Relationships |
|---|---|---|
| Baseline | 44.64 ± 3.92 | 45.66 ± 4.04 |
| Post-intervention follow-up | 44.61 ± 3.35 | 45.56 ± 4.13 |
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).
| scores on a scale | Resource & Referral | Promoting First Relationships |
|---|---|---|
| Baseline | 44.64 ± 3.92 | 45.66 ± 4.04 |
| 6-month follow-up | 43.46 ± 3.48 | 44.52 ± 4.03 |
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.
| scores on a scale | Resource & Referral | Promoting First Relationships |
|---|---|---|
| Baseline | 17.11 ± 9.38 | 17.73 ± 8.53 |
| Post intervention | 17.71 ± 8.86 | 17.16 ± 8.09 |
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.
| scores on a scale | Resource & Referral | Promoting First Relationships |
|---|---|---|
| Baseline | 17.11 ± 9.38 | 17.73 ± 8.53 |
| 6-month follow-up | 19.07 ± 8.92 | 17.56 ± 8.66 |
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.
| scores on a scale | Resource & Referral | Promoting First Relationships |
|---|---|---|
| Baseline | 10.87 ± 7.68 | 11.68 ± 8.46 |
| Post-intervention follow-up | 10.46 ± 7.09 | 12.04 ± 7.58 |
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.
| scores on a scale | Resource & Referral | Promoting First Relationships |
|---|---|---|
| Baseline | 10.87 ± 7.68 | 11.68 ± 8.46 |
| 6-month follow-up | 11.82 ± 7.52 | 11.74 ± 8.22 |
Collected over From enrollment until end of 6-month post-intervention follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Promoting First Relationships - Parents | 0/132 (0%) | 0/132 (0%) | 0/132 (0%) |
| Promoting First Relationships - Children | 0/132 (0%) | 0/132 (0%) | 0/132 (0%) |
| Resource & Referral - Parents | 1/132 (0.8%) | 1/132 (0.8%) | 0/132 (0%) |
| Resource & Referral - Children | 0/132 (0%) | 0/132 (0%) | 0/132 (0%) |
| Event | Promoting First Relationships - Parents | Promoting First Relationships - Children | Resource & Referral - Parents | Resource & Referral - Children |
|---|---|---|---|---|
| DeathGeneral disorders | 0/132 | 0/132 | 1/132 | 0/132 |
Data represent individual parents and children enrolled as dyads
| Age, Continuous(Years) | Promoting First Relationships | Resource & Referral | Total |
|---|---|---|---|
| Parents | 30.99 ± 6.663 | 32.98 ± 5.463 | 31.99 ± 6.162 |
| Children | 2.538 ± 1.378 | 2.545 ± 1.405 | 2.542 ± 1.389 |
| Sex: Female, Male(Participants) | Promoting First Relationships | Resource & Referral | Total |
|---|---|---|---|
| Parents — Female | 107 | 109 | 216 |
| Parents — Male | 25 | 23 | 48 |
| Children — Female | 62 | 64 | 126 |
| Children — Male | 70 | 68 | 138 |
| Race (NIH/OMB)(Participants) | Promoting First Relationships | Resource & Referral | Total |
|---|---|---|---|
| Parents — American Indian or Alaska Native | 6 | 7 | 13 |
| Parents — Asian | 1 | 0 | 1 |
| Parents — Native Hawaiian or Other Pacific Islander | 3 | 2 | 5 |
| Parents — Black or African American | 14 | 17 | 31 |
| Parents — White | 83 | 85 | 168 |
| Parents — More than one race | 25 | 21 | 46 |
| Parents — Unknown or Not Reported | 0 | 0 | 0 |
| Children — American Indian or Alaska Native | 4 | 5 | 9 |
| Children — Asian | 0 | 0 | 0 |
| Children — Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Children — Black or African American | 14 | 11 | 25 |
| Children — White | 70 | 72 | 142 |
| Children — More than one race | 42 | 43 | 85 |
| Children — Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Promoting First Relationships | Resource & Referral | Total |
|---|---|---|---|
| Parents — Hispanic or Latino | 16 | 12 | 28 |
| Parents — Not Hispanic or Latino | 116 | 120 | 236 |
| Parents — Unknown or Not Reported | 0 | 0 | 0 |
| Children — Hispanic or Latino | 26 | 25 | 51 |
| Children — Not Hispanic or Latino | 106 | 107 | 213 |
| Children — Unknown or Not Reported | 0 | 0 | 0 |
| Dyad enrolled relative to COVID-19 pandemic(dyads) | Promoting First Relationships | Resource & Referral | Total |
|---|---|---|---|
| Enrolled prior to COVID-19 | 85 | 83 | 168 |
| Enrolled after COVID-19 pause | 47 | 49 | 96 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Washington