NCT04488523

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 and their caregiver of origin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

6.3 years

First QC Date

July 2, 2020

Last Update Submit

November 12, 2025

Conditions

Keywords

telehealthparent-child relationshipsadolescentQuality communicationHousing stabilityChild welfareEmotional regulation

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (6)

  • Telehealth Satisfaction Questionnaire

    Immediately after the intervention.

  • Family telehealth feedback form

    Two weeks post-baseline.

  • Family telehealth feedback form

    Three weeks post-baseline.

  • Family telehealth feedback form

    Four weeks post-baseline.

  • Family telehealth feedback form

    Five weeks post-baseline.

  • +1 more secondary outcomes

Other Outcomes (18)

  • Family Assessment Device

    Immediately after the intervention

  • Family Assessment Device

    Three months post-intervention.

  • Stress Index for Parents of Adolescents

    Immediately after the intervention.

  • +15 more other outcomes

Study Arms (1)

Family-based Telehealth Treatment

EXPERIMENTAL

A family-based telehealth intervention.

Behavioral: Family-based Telehealth Intervention

Interventions

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.

Family-based Telehealth Treatment

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, 94131, United States

Location

Related Publications (1)

  • Folk JB, Valencia-Ayala C, Holloway ED, Anvar S, Czopp A, Tolou-Shams M. Feasibility and Acceptability of a Family-Based Telehealth Intervention for Families Impacted by the Child Welfare System: Formative Mixed Methods Evaluation. JMIR Form Res. 2024 Oct 15;8:e57939. doi: 10.2196/57939.

MeSH Terms

Conditions

CommunicationEmotional Regulation

Condition Hierarchy (Ancestors)

BehaviorSelf-ControlSocial Behavior

Study Officials

  • Marina Tolou-Shams, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 28, 2020

Study Start

July 1, 2019

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations