Clinical trial NCT04488523: Family Telehealth Project for Foster Care Youth
Official title: Leveraging Technology to Improve Family Relationships for Adolescents in Out-of-Home Placement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Communication
Keywords: telehealth
parent-child relationships
adolescent
Quality communication
Housing stability
Child welfare
Emotional regulation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Visa Foundation
First posted: 2020-07-28
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale
timeFrame: Immediately after the intervention.
measure: Difficulties in Emotion Regulation Scale
timeFrame: Three months post-intervention.
measure: Parent-adolescent General Communication Scale (PPAC)
timeFrame: Immediately after the intervention.
measure: Parent-adolescent General Communication Scale
timeFrame: Three months post-intervention.
Secondary outcomes:
measure: Telehealth Satisfaction Questionnaire
timeFrame: Immediately after the intervention.
measure: Family telehealth feedback form
timeFrame: Two weeks post-baseline.
measure: Family telehealth feedback form
timeFrame: Three weeks post-baseline.
measure: Family telehealth feedback form
timeFrame: Four weeks post-baseline.
measure: Family telehealth feedback form
timeFrame: Five weeks post-baseline.
measure: Family telehealth feedback form
timeFrame: Nine weeks post-baseline.
Other outcomes:
measure: Family Assessment Device
timeFrame: Immediately after the intervention
measure: Family Assessment Device
timeFrame: Three months post-intervention.
measure: Stress Index for Parents of Adolescents
timeFrame: Immediately after the intervention.
measure: Stress Index for Parents of Adolescents
timeFrame: Three months post-intervention.
measure: Pediatric Symptom Checklist
timeFrame: Immediately after the intervention.
measure: Pediatric Symptom Checklist
timeFrame: Three months post-intervention.
measure: Homelessness Asset and Risk Screening Tool
timeFrame: Immediately after the intervention.
measure: Homelessness Asset and Risk Screening Tool
timeFrame: Three months post-intervention.
measure: Adolescent Risk Behavior Assessment
timeFrame: Immediately after the intervention.
measure: Adolescent Risk Behavior Assessment
timeFrame: Three months post-intervention.
measure: National Stressful Events Survey PTSD Short Scale
timeFrame: Immediately after the intervention.
measure: National Stressful Events Survey PTSD Short Scale
timeFrame: Three months post-intervention.
measure: Texas Christian University Drug Screen 5 - Opioid Supplement
timeFrame: Immediately after the intervention.
measure: Texas Christian University Drug Screen 5 - Opioid Supplement
timeFrame: Three months post-intervention.
measure: Asian American Family Conflict Scale
timeFrame: Immediately after the intervention.
measure: Asian American Family Conflict Scale
timeFrame: Three months post-intervention.
measure: DSM-5 Cross Cutting Symptom Inventory
timeFrame: Immediately after the intervention.
measure: DSM-5 Cross Cutting Symptom Inventory
timeFrame: Three months post-intervention.
Locations:
city: San Francisco
country: United States
facility: UCSF Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Marina Tolou-Shams, PhD
role: PRINCIPAL_INVESTIGATOR
References: