357 Participants Needed

Evidence-Based Parenting Services for Families in Child Welfare

KK
Overseen ByKristin Klansnic
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two parenting programs for families in the child welfare system: one delivered in-home and the other via telehealth. The researchers aim to determine how each method improves parenting skills, child behavior, and reduces the likelihood of children entering foster care. They also assess the cost-effectiveness of these programs and whether families possess the necessary technology for telehealth. Parents of children aged 6-12 months with an open child welfare case, who speak English and have the required technology for telehealth, qualify as good candidates for this trial. As an unphased trial, this study allows families to contribute to important research that could enhance parenting support systems.

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 prior data suggests that these parenting programs are safe for families in child welfare?

Research has shown that Promoting First Relationships (PFR) programs are generally safe and well-received by participants. For the home visiting version, studies indicate it effectively helps parents understand and respond to their children's needs. Participants in these studies did not report any major negative effects, suggesting the program is safe for families.

The telehealth version of PFR, delivered through video calls, has also been studied and found safe. It retains the main components of the home visiting program and focuses on improving parent-child interactions. Previous studies have not shown any major safety concerns with this version.

Both versions of PFR aim to strengthen the bond between parents and their children. This approach usually leads to positive experiences for families, with no significant safety issues reported in past research.12345

Why are researchers excited about this trial?

Researchers are excited about Promoting First Relationships (PFR) because it offers a novel way to support families involved in child welfare, distinct from typical parenting programs. Unlike many standard interventions that may not involve direct observation, PFR includes video recordings of parent-child interactions, allowing parents to reflect on and enhance their sensitivity to their child's needs. Additionally, the availability of both home visiting (PFR-HV) and telehealth (PFR-T) formats makes this program accessible and convenient, adapting to different family situations and preferences. This approach not only strengthens the parent-child bond but also aims to reduce the risk of maltreatment, giving it a unique edge over traditional services.

What evidence suggests that this trial's treatments could be effective for families in child welfare?

Research shows that the Promoting First Relationships (PFR) program improves parent-child interactions. In past studies, parents who participated in PFR became more attentive and responsive to their children's needs. This program helps parents understand their child's emotional and social signals, leading to stronger bonds. In this trial, participants will receive either the home visit version (PFR-HV) or the online version (PFR-T). Both versions retain these important features, with the online version designed to provide the same benefits as home visits, making it accessible to more families. Overall, PFR supports better parenting and child development.23456

Who Is on the Research Team?

MO

Monica Oxford, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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.
See 1 more

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)
See 1 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Promoting First Relationships TelehealthExperimental Treatment1 Intervention
Group II: Promoting First Relationships Home VisitingExperimental Treatment1 Intervention
Group III: Control, Resource ConditionActive Control1 Intervention

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

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Approved in United States as Promoting First Relationships for:

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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+

Published Research Related to This Trial

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.
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) 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.
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.
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]

Citations

Promoting First RelationshipsPromoting First Relationships (PFR) involves home visitors providing feedback to parents based on video recordings of the parent's interactions with the child.
Promoting First Relationships®: Randomized Trial of a 10 ...We conducted a community-based randomized control trial with intent-to-treat analysis on Promoting First Relationships (PFR), a 10-week home visiting program.
The development of the Promoting First Relationships ...Promoting First Relationships (PFR) is an evidence-based home-visiting pro- gram for caregivers and their children from birth to age 5 years. It ...
CEBC » Promoting First Relationships › Program › DetailedPromoting First Relationships®: A program for service providers to help parents and other caregivers nurture young children's social and emotional development.
The development of the Promoting First Relationships ...Promoting First Relationships (PFR) is an evidence-based home-visiting program for caregivers and their children from birth to age 5 years.
Promoting First RelationshipsPromoting First Relationships (PFR) includes two versions that are used with parents in the home: (1) PFR-Home Visiting Promotion Model and (2) PFR-Home ...
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