Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth

NCT06109766 | Recruiting

• 2 other identifiers: STUDY000176581R01HD111433-01
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

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?
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Conditions

Parenting; Parent-Child Relations; Child Behavior; Child Maltreatment

Keywords

Telehealth; Fidelity; Cost-Benefit Analysis

Outcome Measures

Primary Outcomes (4)

• Change in parent sensitive and responsive care

  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.

  Baseline, Immediate Post-Intervention (up to 5-months Post Baseline), 6-month Post-intervention Follow-up

• Change in parent sensitive and responsive care

  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.

  Baseline, Immediate Post-Intervention (on average 3.5-4.5 months Post Baseline), 6-month Post-intervention Follow-up

• Change in parental understanding of child social & emotional development

  16-item Likert-scale questionnaire developed by study, "Raising a Baby"

  Baseline, Immediate Post-Intervention (on average 3.5 to 4.5 months Post Baseline), 6-month Post-intervention Follow-up

• Prevention of child welfare out of home placement

  Official child welfare administrative records indicating whether child was removed from the birth parent home.

  Baseline to 1-year Post-Intervention

Secondary Outcomes (1)

• Chang in child externalizing behavior

  Baseline, Immediate Post-Intervention (on average 3.5-4.5 months Post Baseline), 6-month Post-intervention Follow-up

Study Arms (3)

Promoting First Relationships Home Visiting

EXPERIMENTAL

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.

Behavioral: Promoting First Relationships

Promoting First Relationships Telehealth

EXPERIMENTAL

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.

Behavioral: Promoting First Relationships

Control, Resource Condition

NO 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.

Interventions

Promoting First Relationships BEHAVIORAL

Promoting First Relationships ® is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family or over Zoom. 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

Promoting First Relationships Home Visiting; Promoting First Relationships Telehealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• they speak English,
• they are not currently experiencing an acute hospitalization or incarceration,
• they have the technological capacity to engage in telehealth, and
• they have not had PFR in the past.

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Monica Oxford, PhD, MSW

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Klansnic

CONTACT

206-519-7330; klansnic@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research visitor and video coders are masked to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 31, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): April 12, 2028
• Study Completion (Estimated): April 12, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)