- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04488523
Family Telehealth Project for Foster Care Youth
Leveraging Technology to Improve Family Relationships for Adolescents in Out-of-Home Placement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lakshmi Gopalakrishnan
- Phone Number: 415-509-5999
- Email: Lakshmi.Gopalakrishnan@ucsf.edu
Study Contact Backup
- Name: Marina Tolou-Shams, PhD
- Phone Number: 628-206-2212
- Email: marina.tolou-shams@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94131
- Recruiting
- UCSF Zuckerberg San Francisco General Hospital
-
Contact:
- Marina Tolou-Shams, PhD
- Phone Number: 628-206-2212
- Email: marina.tolou-shams@ucsf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Family-based Telehealth Treatment
A 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficulties in Emotion Regulation Scale
Time Frame: Immediately after the intervention.
|
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
Time Frame: Three months post-intervention.
|
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)
Time Frame: Immediately after the intervention.
|
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
Time Frame: Three months post-intervention.
|
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
Time Frame: Immediately after the intervention.
|
To measure attitudes about the delivery of the intervention via telehealth.
|
Immediately after the intervention.
|
Family telehealth feedback form
Time Frame: Two weeks post-baseline.
|
To measure attitudes about the content and delivery of the intervention.
|
Two weeks post-baseline.
|
Family telehealth feedback form
Time Frame: Three weeks post-baseline.
|
To measure attitudes about the content and delivery of the intervention.
|
Three weeks post-baseline.
|
Family telehealth feedback form
Time Frame: Four weeks post-baseline.
|
To measure attitudes about the content and delivery of the intervention.
|
Four weeks post-baseline.
|
Family telehealth feedback form
Time Frame: Five weeks post-baseline.
|
To measure attitudes about the content and delivery of the intervention.
|
Five weeks post-baseline.
|
Family telehealth feedback form
Time Frame: Nine weeks post-baseline.
|
To measure attitudes about the content and delivery of the intervention.
|
Nine weeks post-baseline.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Assessment Device
Time Frame: Immediately after the intervention
|
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
|
Family Assessment Device
Time Frame: Three months post-intervention.
|
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.
|
Stress Index for Parents of Adolescents
Time Frame: Immediately after the intervention.
|
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.
|
Stress Index for Parents of Adolescents
Time Frame: Three months post-intervention.
|
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.
|
Pediatric Symptom Checklist
Time Frame: Immediately after the intervention.
|
To measure youth psychiatric symptoms.
Scores range from 0 to 70, with scores of 30 or higher indicating psychological impairment.
|
Immediately after the intervention.
|
Pediatric Symptom Checklist
Time Frame: Three months post-intervention.
|
To measure youth psychiatric symptoms.
Scores range from 0 to 70, with scores of 30 or higher indicating psychological impairment.
|
Three months post-intervention.
|
Homelessness Asset and Risk Screening Tool
Time Frame: Immediately after the intervention.
|
To measure risk for homelessness and residential stability.
|
Immediately after the intervention.
|
Homelessness Asset and Risk Screening Tool
Time Frame: Three months post-intervention.
|
To measure risk for homelessness and residential stability.
|
Three months post-intervention.
|
Adolescent Risk Behavior Assessment
Time Frame: Immediately after the intervention.
|
To measure youth substance use and youth sexual risk behavior.
|
Immediately after the intervention.
|
Adolescent Risk Behavior Assessment
Time Frame: Three months post-intervention.
|
To measure youth substance use and youth sexual risk behavior.
|
Three months post-intervention.
|
National Stressful Events Survey PTSD Short Scale
Time Frame: Immediately after the intervention.
|
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.
|
National Stressful Events Survey PTSD Short Scale
Time Frame: Three months post-intervention.
|
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.
|
Texas Christian University Drug Screen 5 - Opioid Supplement
Time Frame: Immediately after the intervention.
|
To measure youth substance use.
|
Immediately after the intervention.
|
Texas Christian University Drug Screen 5 - Opioid Supplement
Time Frame: Three months post-intervention.
|
To measure youth substance use.
|
Three months post-intervention.
|
Asian American Family Conflict Scale
Time Frame: Immediately after the intervention.
|
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.
|
Asian American Family Conflict Scale
Time Frame: Three months post-intervention.
|
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.
|
DSM-5 Cross Cutting Symptom Inventory
Time Frame: Immediately after the intervention.
|
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.
|
DSM-5 Cross Cutting Symptom Inventory
Time Frame: Three months post-intervention.
|
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.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marina Tolou-Shams, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1928922
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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