Evidence-Based Parenting Services for Families in Child Welfare

Overseen By Kristin Klansnic

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Acute crisis, Unstable housing, No internet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

357 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled trial is to compare Promoting First Relationships - Home Visit (PFR-HV) to Promoting First Relationships - Telehealth (PFR-T) among parents of 6-12 month olds in the child welfare system. The main questions it aims to answer are: * Is PFR-T effective relative to PFR-HV and Usual Care with respect to observed parent sensitive and responsive care, parent knowledge of child social and emotional development, and child externalizing behavior? * Is PFR-T effective relative to PFR-HV and Usual Care with respect to child out-of-home placement in foster care relative to the control group? * How does PFR-T compare in a benefit-cost analysis to the cost-effectiveness relative to PFR-HV and Usual Care? * Are eligible families impacted by the lack of technology and Wi-Fi/cellular data to engage in PFR-T? * How does provider adherence and fidelity in delivery of PFR-T compare to adherence and fidelity of PFR-HV? What will participants be asked to do? 1. Participants will be asked to agree to randomization, resulting in their placement in one of three groups: PFR-HV, PFR-T, or the control group. 2. Participants will be asked to participate in three virtual research visits, over the course of approximately 12 months (families could be finished as early as 9 months, however in our experience, intervention sessions and research visits often need to be rescheduled, delaying completion of the study). The research visits take approximately 80 minutes, and families will be paid $75 for each visit they participate in. 3. During the research visit, the families will be asked to participate in videotaped research activities involving parent-child play and interaction. Parents will be asked to answer questions regarding their background, feelings, parenting opinions, and stress. 4. Families randomized to the PFR-HV intervention are asked to participate in a 10 week in home parenting program which includes videotaped caregiver-child interactions and feedback. 5. Families randomized to the PFR-T intervention are asked to participate in a 10-week parenting program that will occur over Zoom, which will include videotaped caregiver-child interactions and feedback. 6. Families randomized to the control group will be emailed a resource packet with some information about services or programs that might be helpful for them.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Promoting First Relationships for families in child welfare?

Research shows that Promoting First Relationships (PFR) helps improve caregivers' understanding of children's social and emotional needs and reduces depressive symptoms in caregivers. It also enhances the quality of caregiver-child interactions, especially when caregivers initially have lower levels of depressive symptoms. ^{1 2 3 4 5}

Is the Promoting First Relationships program safe for participants?

The Promoting First Relationships program has been tested in various studies, and while they focus on effectiveness, they also report high participant satisfaction, suggesting a positive experience without safety concerns. ^{1 2 5 6 7}

What makes the Promoting First Relationships treatment unique for families in child welfare?

Promoting First Relationships is unique because it is a 10-week home visiting program that focuses on enhancing parent sensitivity and understanding of toddlers' social and emotional needs, which can help prevent child removals and improve attachment. Unlike other treatments, it is specifically designed for families involved with child protective services and has shown promise in reducing atypical affective communication in children and increasing stable placements with foster/kin caregivers. ^{1 2 6 7 8}

Research Team

Monica Oxford, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for English-speaking birth parents with a child aged 6-12 months involved in an open CPS investigation. They must have the tech needed for telehealth and not be hospitalized or incarcerated. Parents who've had PFR or CPP, lack stable housing, or reliable internet/device access are excluded.

Inclusion Criteria

I can use technology for virtual doctor visits.

I have never had a PFR before.

I am a parent in the DCYF database with an open CPS case and a child aged 6-12 months.

Exclusion Criteria

I have undergone Promoting First Relationships or Child Parent Psychotherapy.

They don't have stable enough housing to be able to have home visits

Parents will not be eligible if they are experiencing an acute crisis (e.g., hospitalization, incarceration)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-randomization Research Visit

Participants undergo a pre-randomization research visit to collect baseline data

1 visit

1 visit (virtual)

Treatment

Participants receive either PFR-HV or PFR-T intervention for 10 weeks, or are placed in the control group

10 weeks

Weekly sessions (in-person or virtual depending on group)

Post-intervention Research Visit

Participants undergo a post-intervention research visit to assess immediate outcomes

1 visit

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (virtual)

Treatment Details

Interventions

• Promoting First Relationships

Trial Overview The study compares two methods of delivering parenting support: Promoting First Relationships through home visits (PFR-HV) and via telehealth (PFR-T), against usual care. It will assess parent-child interaction quality, knowledge on child development, child behavior, placement outcomes, cost-effectiveness, and program delivery fidelity.

Participant Groups

Group I: Promoting First Relationships Telehealth Experimental Treatment 1 Intervention

PFR-T is a 10-week telehealth parenting support program. PFR-T retains all of the core content features of PFR-HV: use of parent-child interaction during play as a way to reflect on the child's social and emotional needs, use of handouts and exercises to deepen the learning, and thoughts for the week. The parent-child video observations will be completed online over Zoom. The provider will mail the handouts to participants before starting PFR-T and send handouts by email as a backup. To discuss the handouts, the provider will use "share screen." During five of the weekly sessions, the provider uses the "record" feature of Zoom to record playtime between parent and child. At the next visit, the PFR-T provider will use "share screen" to playback the video to offer positive instructive and reflective feedback and facilitate discussion. As is typical in PFR, the provider will be able to pause or rewind the recording as needed.

Group II: Promoting First Relationships Home Visiting Experimental Treatment 1 Intervention

PFR-HV is a 10-week home-based parenting support program that promotes parental sensitivity and reduce the risk of maltreatment. PFR uses a curriculum, each week consisting of a theme for discussion and an activity. Sessions includes at least two handouts, one with new content and one titled "Thoughts for the Week," which asks parents to think about a topic discussed in the session and apply it to their relationship with their child. On alternating weeks, the provider video records the parent-child dyad playing for 10 minutes. The following week the parent and provider view the video recording, and the provider guides the parent to reflect on their observation of the play. When the parent is sensitive to the child's needs, the provider acknowledges that with positive instructive comments. When there is tension between child and parent, the provider pauses the video and asks reflective questions, which allows parents to reconsider the meaning behind their child's behavior.

Group III: Control, Resource Condition Active Control 1 Intervention

For families randomized to the control group, they will not receive any intervention in the 3 month timeframe between the first two research visits. The research coordinator will maintain contact with the families in this group, and they will be emailed a resource packet with some information about services or programs that might be helpful for them based on the area they reside.

Promoting First Relationships is already approved in United States for the following indications:

Approved in United States as Promoting First Relationships for:

• Supporting parents of children from birth through age 5 years
• Improving parenting and toddler outcomes for toddlers in state dependency
• Enhancing parent-child relationships

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

The Promoting First Relationships® (PFR) program was found to be effective in enhancing caregiver-child relationships and promoting personal growth among participants in a Native community, as evidenced by both quantitative and qualitative data from a randomized controlled trial.

Focus group discussions highlighted the importance of cultural relevance and provided valuable feedback on challenges faced by participants, suggesting that adaptations to the program could further improve its effectiveness in Native communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Native Participants in the Promoting First Relationships® Intervention: Focus Group Findings. O'Leary, R., Oxford, ML., Booth-LaForce, C., et al.[2023]

The Promoting First Relationships (PFR) intervention showed high adherence to program content, with 97% of elements completed in actual cases, indicating strong implementation fidelity among providers.

Participant satisfaction was notably high, averaging 3.9 out of 4, suggesting that the PFR program is not only effectively delivered but also well-received by families in child welfare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ensuring Implementation Fidelity of a 10-Week Home Visiting Program in Two Randomized Clinical Trials. Oxford, ML., Spieker, SJ., Lohr, MJ., et al.[2019]

The Promoting First Relationships® (PFR) program significantly improved caregivers' knowledge about children's social-emotional needs and reduced depressive symptoms among participants, with assessments conducted on 162 Native caregivers and their toddlers over multiple time points.

Caregiver-child interactions were notably better in the PFR group three months after the intervention, especially among caregivers with lower initial depressive symptoms, indicating that the program is particularly effective under certain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting First Relationships® for Primary Caregivers and Toddlers in a Native Community: a Randomized Controlled Trial. Booth-LaForce, C., Oxford, ML., O'Leary, R., et al.[2023]

The Promoting First Relationship (PFR) intervention was effectively delivered by trained tribal members in a Native community, achieving a very high adherence score of 0.99, indicating strong fidelity to the program's content.

Despite facing challenges that led to high attrition before delivery, participants who completed the program reported high satisfaction levels (average score of 3.90 out of 4), demonstrating the program's acceptability and potential effectiveness in fostering positive caregiver-child relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation fidelity of the Promoting First Relationships intervention program in a Native community. Booth-LaForce, C., Oxford, ML., O'Leary, R., et al.[2023]

The Promoting First Relationships (PFR) program, a 10-week home visiting initiative with video feedback, significantly improved maternal sensitivity and understanding of infant social-emotional needs in a study of 252 mothers and their infants, many of whom faced mental health challenges.

Mothers who participated in the PFR program reported less externalizing behavior in their infants by 12 months of age, indicating that the program may positively influence both maternal and infant outcomes in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of promoting first relationships for new mothers who received community mental health services in pregnancy. Oxford, ML., Hash, JB., Lohr, MJ., et al.[2022]

The Promoting First Relationships® (PFR) program, a 10-week home visiting intervention, did not show overall differences in placement stability or permanency for toddlers with recent placement disruptions, involving 210 participants.

However, foster/kin caregivers who participated in the PFR program were more likely to provide stable care and achieve legal guardianship or adoption of the toddlers compared to those in the comparison group, highlighting the program's potential benefits for this specific caregiver type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permanency Outcomes for Toddlers in Child Welfare Two Years After a Randomized Trial of a Parenting Intervention. Spieker, SJ., Oxford, ML., Fleming, CB.[2021]

The Promoting First Relationships® (PFR) program, a 10-week home visiting intervention, significantly improved parents' understanding of their toddlers' social-emotional needs and increased parental sensitivity compared to a resource and referral service, based on a study of 247 families.

Children in the PFR group were less likely to be placed into foster care (6% vs. 13%) within a year after the intervention, indicating that PFR may effectively prevent child removals in families involved with child protective services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting First Relationships®: Randomized Trial of a 10-Week Home Visiting Program With Families Referred to Child Protective Services. Oxford, ML., Spieker, SJ., Lohr, MJ., et al.[2019]

The Promoting First Relationships® (PFR) intervention significantly improved parental sensitivity among 247 parents involved with child protective services, which in turn enhanced toddlers' secure base behavior after 6 months.

The positive effects of the PFR intervention were particularly strong for parents with a history of physical abuse in their childhood, suggesting that the intervention may be especially beneficial for those at higher risk of passing on negative parenting patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Parents' Own History of Child Abuse Moderate the Effectiveness of the Promoting First Relationships® Intervention in Child Welfare? Pasalich, DS., Fleming, CB., Spieker, SJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Experiences of Native Participants in the Promoting First Relationships® Intervention: Focus Group Findings. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Ensuring Implementation Fidelity of a 10-Week Home Visiting Program in Two Randomized Clinical Trials. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Promoting First Relationships® for Primary Caregivers and Toddlers in a Native Community: a Randomized Controlled Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Implementation fidelity of the Promoting First Relationships intervention program in a Native community. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of promoting first relationships for new mothers who received community mental health services in pregnancy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Permanency Outcomes for Toddlers in Child Welfare Two Years After a Randomized Trial of a Parenting Intervention. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Promoting First Relationships®: Randomized Trial of a 10-Week Home Visiting Program With Families Referred to Child Protective Services. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Does Parents' Own History of Child Abuse Moderate the Effectiveness of the Promoting First Relationships® Intervention in Child Welfare? [2022]