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Completed

NCT Number: NCT04488523

Family Telehealth Project for Foster Care Youth

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.

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Key information

Conditions

Parent-Child Relations Behavior Communication Emotional Regulation Self-Control Social Behavior

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, 94131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family-based Telehealth Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Telehealth Satisfaction Questionnaire

    Time frame: Immediately after the intervention.

    To measure attitudes about the delivery of the intervention via telehealth.

  2. Family telehealth feedback form

    Time frame: Two weeks post-baseline.

    To measure attitudes about the content and delivery of the intervention.

  3. Family telehealth feedback form

    Time frame: Three weeks post-baseline.

    To measure attitudes about the content and delivery of the intervention.

  4. Family telehealth feedback form

    Time frame: Four weeks post-baseline.

    To measure attitudes about the content and delivery of the intervention.

  5. Family telehealth feedback form

    Time frame: Five weeks post-baseline.

    To measure attitudes about the content and delivery of the intervention.

  6. Family telehealth feedback form

    Time frame: Nine weeks post-baseline.

    To measure attitudes about the content and delivery of the intervention.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Homelessness Asset and Risk Screening Tool

    Time frame: Immediately after the intervention.

    To measure risk for homelessness and residential stability.

  8. Homelessness Asset and Risk Screening Tool

    Time frame: Three months post-intervention.

    To measure risk for homelessness and residential stability.

  9. Adolescent Risk Behavior Assessment

    Time frame: Immediately after the intervention.

    To measure youth substance use and youth sexual risk behavior.

  10. Adolescent Risk Behavior Assessment

    Time frame: Three months post-intervention.

    To measure youth substance use and youth sexual risk behavior.

  11. 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.

  12. 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.

  13. Texas Christian University Drug Screen 5 - Opioid Supplement

    Time frame: Immediately after the intervention.

    To measure youth substance use.

  14. Texas Christian University Drug Screen 5 - Opioid Supplement

    Time frame: Three months post-intervention.

    To measure youth substance use.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Visa Foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2020
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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