Clinical trial NCT06109766: Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth
Official title: Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Parent-Child Relations
Child Behavior
Child Maltreatment
Keywords: Telehealth
Fidelity
Cost-Benefit Analysis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-10-31
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The severe acute respiratory syndrome coronavirus 2 (denoted COVID-19) pandemic has shaken the foundation of services delivered to vulnerable families involved with or monitored by the child protective/welfare system. COVID-19 has changed the landscape of how children and families interact with the vital services provided by the child welfare system. Home visitation, which includes a bedrock of essential and transformative parenting support services for families involved with child welfare, was no longer safe or viable in the presence of COVID-19. The pandemic shredded safety nets. It made evident to providers, administrators, and policymakers how fragile our child protective system is. Under this strained state, child welfare agencies and mental health providers innovated service delivery systems. In Washington State, the Department of Children, Youth, and Families (DCYF) worked with local service agencies providing evidence-based programs to revise program protocols. Provider teams and program developers worked together to transition in-person services to remote platforms by developing and delivering telehealth services to families. The pandemic created the conditions for a natural experiment in service delivery in Washington State. The natural experiment proved that telehealth services are a viable service delivery system; thousands of child welfare involved families were served via telehealth. We do not know, however, if these services were effective, or which families had the technological capacity to engage, or for those who did engage were they able to complete the program. Did online home visiting produce the expected outcomes? While online delivery was an innovation driven by the necessity in response to COVID-19, many questions remain. The potential is high, but little is known about telehealth in child welfare.

This proposal is a three-arm effectiveness trail of an evidence-based home visiting program: 1) delivered online (PFR-T), 2) delivered in-person home visiting (PFR-HV), and 3) usual care (UC) for 357 parents under CPS investigation for a child between the age of 6-12 months at enrollment. We will assess the effectiveness of Promoting First Relationships (PFR: a 10-week model) to improve observed parent-child interaction and caregivers' knowledge of social and emotional development. We will also assess if PFR reduces child externalizing behavior and reduces out of home placements of the child into foster care in both PFR-T and PFR-HV relative to UC. We will assess the cost-effectiveness of providing PFR-T relative to PFR-HV. We will address the degree to which families in Child Protective Services (CPS) have the technology needed to engage with telehealth services, as well as family satisfaction and compliance. Finally, we will measure service providers' fidelity to the PFR model and their adherence to delivering PFR via telehealth compared to home visiting. The proposed study leverages a longstanding partnership between the University of Washington and Washington State DCYF, overseeing services in child welfare to answer these questions.

Methods: The Families Connected study will entail a pre-randomization research visit, a post-intervention research visit, and a six-month follow-up research visit. Participants will be randomized using a computer algorithm after their first research visit. We will also have signed consent from participants for study participation including electronic child welfare administrative data from WA DCYF, from birth to five years post-intervention, for longitudinal assessment of child welfare outcomes. Measures include self-report survey, observational assessments coded by a blinded research assistant, and child welfare administrative data up to five years post intervention. Part of the screening includes question, answers to these will be used for Aim 4, which assesses the technological capacity of families involved in the Child Protective SystemThe screening recruitment script includes five questions. Those being recruited will be asked if they are willing to answer some questions on their technology capacity, if yes the recruitment staff will ask the five questions. We estimate that we will collect data from approximately 1,000 families during the recruitment screening process.

Eligibility criteria: Inclusion Criteria: Birth parents will be eligible if:

1. they are listed in the official DCYF child welfare database as having an open CPS or FAR intake and a child listed in the case file who is between 6-12 months old,
2. they speak English,
3. they are not currently experiencing an acute hospitalization or incarceration,
4. they have the technological capacity to engage in telehealth, and
5. they have not had PFR in the past.

Exclusion Criteria: Parents will not be eligible if

1. they are experiencing an acute crisis (e.g., hospitalization, incarceration),
2. they don't have stable enough housing to be able to have home visits,
3. they don't have reliable access to internet or cell service and/or a device with a microphone and camera,
4. previously received the Promoting First Relationships ® intervention or Child Parent Psychotherapy (CPP).

Primary outcomes:
measure: Change in parent sensitive and responsive care
timeFrame: Baseline, Immediate Post-Intervention (up to 5-months Post Baseline), 6-month Post-intervention Follow-up
measure: Change in parent sensitive and responsive care
timeFrame: Baseline, Immediate Post-Intervention (on average 3.5-4.5 months Post Baseline), 6-month Post-intervention Follow-up
measure: Change in parental understanding of child social & emotional development
timeFrame: Baseline, Immediate Post-Intervention (on average 3.5 to 4.5 months Post Baseline), 6-month Post-intervention Follow-up
measure: Prevention of child welfare out of home placement
timeFrame: Baseline to 1-year Post-Intervention
Secondary outcomes:
measure: Chang in child externalizing behavior
timeFrame: Baseline, Immediate Post-Intervention (on average 3.5-4.5 months Post Baseline), 6-month Post-intervention Follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Monica Oxford, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: