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Family Telehealth Project for Foster Care Youth

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ClinicalTrials.gov Identifier: NCT04488523
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
Visa Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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 in out-of-home placement and their caregiver of origin.

Condition or disease Intervention/treatment Phase
Parent-Child Relations Communication Behavioral: Family-based Telehealth Intervention Not Applicable

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 to CWI youth in out-of-home placement and their caregiver of origin. The study involves iteratively adapt the intervention with feedback from youth and caregiver participants and stakeholder partners, as well as evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Leveraging Technology to Improve Family Relationships for Adolescents in Out-of-Home Placement
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: Family-based Telehealth Treatment
A family-based telehealth intervention.
Behavioral: Family-based Telehealth Intervention
The Family Telehealth intervention focused on improving parent-child relationships and communication. 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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Telehealth Satisfaction Questionnaire [ Time Frame: Immediately after the intervention. ]
    To measure attitudes about the delivery of the intervention via telehealth.

  2. Telehealth Satisfaction Questionnaire [ Time Frame: Three months post-intervention. ]
    To measure attitudes about the delivery of the intervention via telehealth.

  3. Family telehealth feedback form [ Time Frame: Two weeks post-baseline. ]
    To measure attitudes about the content and delivery of the intervention.

  4. Family telehealth feedback form [ Time Frame: Three weeks post-baseline. ]
    To measure attitudes about the content and delivery of the intervention.

  5. Family telehealth feedback form [ Time Frame: Four weeks post-baseline. ]
    To measure attitudes about the content and delivery of the intervention.

  6. Family telehealth feedback form [ Time Frame: Five weeks post-baseline. ]
    To measure attitudes about the content and delivery of the intervention.

  7. Family telehealth feedback form [ Time Frame: Six weeks post-baseline. ]
    To measure attitudes about the content and delivery of the intervention.


Other Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible youth:

  • Will be between the ages of 12 and 18 years
  • Currently placed out-of-home due to child welfare involvement
  • Proficient in English
  • Have no cognitive impairment which would preclude provision of informed assent

Eligible caregivers

  • Will be the caregiver of origin for the enrolled youth
  • Proficient in English
  • Cognitively capable of providing informed consent for themselves and their youth.

Exclusion Criteria:

  • Caregivers whose rights were terminated due to substantiated abuse or neglect.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488523


Contacts
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Contact: Marina Tolou-Shams, PhD 628-206-2212 marina.tolou-shams@ucsf.edu
Contact: Johanna Folk, PhD 628-206-2309 johanna.folk@ucsf.edu

Locations
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United States, California
UCSF Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94131
Contact: Marina Tolou-Shams, PhD    628-206-2212    marina.tolou-shams@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Visa Foundation
Investigators
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Principal Investigator: Marina Tolou-Shams, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04488523    
Other Study ID Numbers: 1928922
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
telehealth
parent-child relationships
adolescent
Quality communication
Housing stability
Child welfare
Emotional regulation