Family Telehealth Project for Foster Care Youth

Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04488523
• Other study ID #: 1928922
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Marina Tolou-Shams, PhD
• Phone: 628-206-2212
• Email: marina.tolou-shams[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communication
• Parent-Child Relations

Intervention

Behavioral:
• Family-based Telehealth Intervention
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.

Locations

Country	Name	City	State
United States	UCSF Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Visa Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family Assessment Device	To measure general family functioning, affective responsiveness, and affective involvement. Scores range from 1 to 4 for each of the scales, with higher scores reflecting unhealthy family functioning.	Immediately after the intervention
Other	Family Assessment Device	To measure general family functioning, affective responsiveness, and affective involvement. Scores range from 1 to 4 for each of the scales, with higher scores reflecting unhealthy family functioning.	Three months post-intervention.
Other	Stress Index for Parents of Adolescents	To measure caregiver-youth relationship quality and caregiver parenting stress. The items are scored on a 5-point rating scale, with raw scores then categorized as within normal limits, borderline, clinically significant, or clinically severe.	Immediately after the intervention.
Other	Stress Index for Parents of Adolescents	To measure caregiver-youth relationship quality and caregiver parenting stress. The items are scored on a 5-point rating scale, with raw scores then categorized as within normal limits, borderline, clinically significant, or clinically severe.	Three months post-intervention.
Other	Pediatric Symptom Checklist	To measure youth psychiatric symptoms. Scores range from 0 to 70, with scores of 30 or higher indicating psychological impairment.	Immediately after the intervention.
Other	Pediatric Symptom Checklist	To measure youth psychiatric symptoms. Scores range from 0 to 70, with scores of 30 or higher indicating psychological impairment.	Three months post-intervention.
Other	Homelessness Asset and Risk Screening Tool	To measure risk for homelessness and residential stability.	Immediately after the intervention.
Other	Homelessness Asset and Risk Screening Tool	To measure risk for homelessness and residential stability.	Three months post-intervention.
Other	Adolescent Risk Behavior Assessment	To measure youth substance use and youth sexual risk behavior.	Immediately after the intervention.
Other	Adolescent Risk Behavior Assessment	To measure youth substance use and youth sexual risk behavior.	Three months post-intervention.
Other	National Stressful Events Survey PTSD Short Scale	To assess the severity of posttraumatic stress disorder in youth. The item are scored on a 5-point rating scale (from 0 to 4). Scores range from 0 to 28, with higher scores indicating greater severity of acute stress disorder.	Immediately after the intervention.
Other	National Stressful Events Survey PTSD Short Scale	To assess the severity of posttraumatic stress disorder in youth. The item are scored on a 5-point rating scale (from 0 to 4). Scores range from 0 to 28, with higher scores indicating greater severity of acute stress disorder.	Three months post-intervention.
Other	Texas Christian University Drug Screen 5 - Opioid Supplement	To measure youth substance use.	Immediately after the intervention.
Other	Texas Christian University Drug Screen 5 - Opioid Supplement	To measure youth substance use.	Three months post-intervention.
Other	Asian American Family Conflict Scale	To assess caregiver perceptions of intergenerational acculturation conflict. The items are scored on a 5-point rating scale. Scores range from 10 to 50, with higher scores indicating greater family conflict.	Immediately after the intervention.
Other	Asian American Family Conflict Scale	To assess caregiver perceptions of intergenerational acculturation conflict. The items are scored on a 5-point rating scale. Scores range from 10 to 50, with higher scores indicating greater family conflict.	Three months post-intervention.
Other	DSM-5 Cross Cutting Symptom Inventory	To assess caregiver mental health domains that are important across psychiatric diagnoses. The items are scored on a 5-point rating scale (from 0 to 4). The score on each item within a domain should be reviewed. A rating of mild (i.e., 2) or greater on any item within a domain (except for substance use, suicidal ideation, and psychosis) and a rating of slight (i.e., 1) or greater on any item within a substance use, suicidal ideation, or psychosis domain may serve as a guide for additional inquiry and follow up to determine if a more detailed assessment for that domain is necessary.	Immediately after the intervention.
Other	DSM-5 Cross Cutting Symptom Inventory	To assess caregiver mental health domains that are important across psychiatric diagnoses. The items are scored on a 5-point rating scale (from 0 to 4). The score on each item within a domain should be reviewed. A rating of mild (i.e., 2) or greater on any item within a domain (except for substance use, suicidal ideation, and psychosis) and a rating of slight (i.e., 1) or greater on any item within a substance use, suicidal ideation, or psychosis domain may serve as a guide for additional inquiry and follow up to determine if a more detailed assessment for that domain is necessary.	Three months post-intervention.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Telehealth Satisfaction Questionnaire	To measure attitudes about the delivery of the intervention via telehealth.	Immediately after the intervention.
Secondary	Family telehealth feedback form	To measure attitudes about the content and delivery of the intervention.	Two weeks post-baseline.
Secondary	Family telehealth feedback form	To measure attitudes about the content and delivery of the intervention.	Three weeks post-baseline.
Secondary	Family telehealth feedback form	To measure attitudes about the content and delivery of the intervention.	Four weeks post-baseline.
Secondary	Family telehealth feedback form	To measure attitudes about the content and delivery of the intervention.	Five weeks post-baseline.
Secondary	Family telehealth feedback form	To measure attitudes about the content and delivery of the intervention.	Nine weeks post-baseline.