Family Telehealth Project for Foster Care Youth

November 12, 2025 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94131
        • UCSF Zuckerberg San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Family-based Telehealth Treatment
A family-based telehealth 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Visa Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marina Tolou-Shams, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1928922

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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