Recruiting

Telehealth Parenting

Sponsor:

University of Washington

Code:

NCT06109766

Conditions

Parenting

Parent-Child Relations

Child Behavior

Child Maltreatment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Promoting First Relationships

Study Details

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.

Conditions

Parenting

Parent-Child Relations

Child Behavior

Child Maltreatment

Study ID

NCT06109766

Start date

Oct 12, 2023

Status verified date

Mar, 2026

Completion date

Apr 12, 2028

Anticipated

Primary completion date

Apr 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

357 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Promoting First Relationships Home Visiting

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.

experimental: Promoting First Relationships Telehealth

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.

no intervention: Control, Resource Condition

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

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.

Primary outcome measure

  • Change in parent sensitive and responsive care [ Time Frame: Baseline, Immediate Post-Intervention (up to 5-months Post Baseline), 6-month Post-intervention Follow-up ]
  • Change in parent sensitive and responsive care [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to 1-year Post-Intervention ]

Central Contacts and Locations

Central contacts

Kristin Klansnic

206-519-7330klansnic@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

Monica Oxford, PhD

More Information

Sponsor

University of Washington

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Telehealth
  • Fidelity
  • Cost-Benefit Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-03-16.