Family Telehealth Project for Foster Care Youth

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to adapt and evaluate the efficacy of an existing family based intervention to be delivered via telehealth to child welfare-involved (CWI) youth and their caregiver of origin.

Detailed Description
-----------------
The goal of this study is to adapt and evaluate the efficacy of an existing empirically supported, family-based affect management intervention to be delivered via telehealth. There are two versions of this intervention: 1) a dyadic version to be delivered to CWI youth and their caregiver of origin, and 2) a caregiver-only version to be delivered to any caregiver (including kinship caregivers) of a CWI youth. The study involves iteratively adapting the intervention with feedback from youth and caregiver participants and stakeholder partners, as well as evaluating the feasibility, acceptability, and preliminary effectiveness of the intervention.

Official Title
-----------------
Leveraging Technology to Improve Family Relationships for Adolescents in Out-of-Home Placement

Conditions
-----------------
Communication, Parent-Child Relations

Intervention / Treatment
-----------------
* Behavioral: Family-based Telehealth Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible youth: Will be between the ages of 12 and 18 years Will have ongoing child welfare involvement Will be proficient in English Will have no cognitive impairment which would preclude provision of informed assent Eligible caregivers for dyadic version: Will be the caregiver of origin for the enrolled youth Will be proficient in English or Spanish Will be cognitively capable of providing informed consent for themselves and their youth Eligible caregivers for caregiver-only version: Will be the caregiver of a youth, between the ages of 12 and 18 years, with ongoing child welfare involvement Will be proficient in English or Spanish Will have no cognitive impairment which would preclude provision of informed consent Exclusion Criteria: Caregivers whose rights were terminated due to substantiated abuse or neglect.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This study is designed to iteratively adapt a family-based intervention with feedback from youth and caregiver participants and stakeholder partners, as well as to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family-based Telehealth Treatment<br>A family-based telehealth intervention. | Behavioral: Family-based Telehealth Intervention<br>* The Family Telehealth intervention focuses on improving parent-child relationships and communication. For the dyadic version, the intervention involves eleven hours of intervention material; it includes motivational interviews, individual and joint sessions co-led by two separate clinicians. The sessions will be delivered on a weekly basis. For the caregiver-only version, the intervention involves six hours of intervention material; it includes a motivational interview and individual sessions led by a single clinician. The sessions will be delivered on a weekly basis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulties in Emotion Regulation Scale | To measure caregiver and youth affect management skills. Scores range from 36 to 180, with higher scores indicating greater problems with emotion regulation. | Immediately after the intervention. | 
| Difficulties in Emotion Regulation Scale | To measure caregiver and youth affect management skills. Scores range from 36 to 180, with higher scores indicating greater problems with emotion regulation. | Three months post-intervention. | 
| Parent-adolescent General Communication Scale (PPAC) | To measure caregiver-youth communication. The PPAC measures both positive and negative communication. Scores for positive communication ranging from 7 to 35, with higher scores indicating more positive communication. Scores for negative communication range from 13 to 65, with higher scores indicating more negative communication. | Immediately after the intervention. | 
| Parent-adolescent General Communication Scale | To measure caregiver-youth communication. The PPAC measures both positive and negative communication. Scores for positive communication ranging from 7 to 35, with higher scores indicating more positive communication. Scores for negative communication range from 13 to 65, with higher scores indicating more negative communication. | Three months post-intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telehealth Satisfaction Questionnaire | To measure attitudes about the delivery of the intervention via telehealth. | Immediately after the intervention. | 
| Family telehealth feedback form | To measure attitudes about the content and delivery of the intervention. | Two weeks post-baseline. | 
| Family telehealth feedback form | To measure attitudes about the content and delivery of the intervention. | Three weeks post-baseline. | 
| Family telehealth feedback form | To measure attitudes about the content and delivery of the intervention. | Four weeks post-baseline. | 
| Family telehealth feedback form | To measure attitudes about the content and delivery of the intervention. | Five weeks post-baseline. | 
| Family telehealth feedback form | To measure attitudes about the content and delivery of the intervention. | Nine weeks post-baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telehealth, parent-child relationships, adolescent, Quality communication, Housing stability, Child welfare, Emotional regulation