NCT04273126

Brief Summary

The goal of this study is to pilot an adapted family resilience program among families with a recent history of homelessness in Los Angeles County and to assess for feasibility and acceptability. The investigators have adapted a family resilience program called Families Overcoming Under Stress (FOCUS), a trauma-informed intervention designed for families experiencing trauma, parental substance use, and homelessness. Our primary hypothesis is that the adapted family resilience program will be feasible and acceptable to families with a recent history of homelessness. Families that are eligible to participate in the study will be assigned to the adapted family resilience intervention. The intervention program consists of around 8-10 modules lasting up to one hour each. The program provides psychoeducation and teaches resilience skills including communication, problem solving, goal setting, and how to deal with stress. Families will be asked to fill out 3 surveys (one at the beginning of the program, one at the end of the program, and at 6 months follow-up). Some families may also be asked to participate in a hour long interview after the completion of the program for feedback on the program. At this time, all assessments and intervention are being conducted remotely due to the pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

February 19, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2023

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

3.1 years

First QC Date

January 22, 2020

Last Update Submit

June 10, 2024

Conditions

Keywords

resilience, psychologicalhomelessness

Outcome Measures

Primary Outcomes (4)

  • Feasibility of the adapted family resilience intervention for families experiencing homelessness and parental SUDs through retention rates of participants.

    Feasibility is defined as the extent to which the adapted intervention can be implemented with families with an experience of homelessness and parental SUDs, assessed through measuring rate of retention of participants.

    6 months

  • Feasibility of the adapted family resilience intervention for families experiencing homelessness and parental SUDs through completion of program core components.

    Feasibility is defined as the extent to which the adapted intervention can be implemented with families with an experience of homelessness and parental SUDs, assessed through measuring number of program core components completed by participants.

    3 months

  • Acceptability of the adapted family resilience intervention to families experiencing homelessness and parental SUDs through qualitative interviews with youth and parents inquiring about intervention acceptability.

    The investigators will assess acceptability of implementing the adapted intervention with families experiencing homelessness and parental SUDs by conducting qualitative interviews with a subset of parent and youth participants completing the intervention. The interviews will explore acceptability of the intervention to families experiencing homelessness and parental substance use disorders and recommendations for improvement. The interviews will be audio-recorded, transcribed, and analyzed using thematic content analysis.

    3 months

  • Acceptability of the adapted family resilience intervention through a self-report intervention acceptability measure.

    Acceptability is defined as the perception that the adapted intervention is agreeable and satisfactory.The investigators will administer a self-report measure of the acceptability of core components of the intervention to be completed following the intervention by parents and youth, with higher score indicating greater acceptability of the intervention to families experiencing homelessness and parental SUDs. Each individual item is scaled with a range of 1 (low) to 5 (high).

    3 months

Secondary Outcomes (21)

  • Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)

    Baseline, 3 month, 6 month

  • Addiction Severity Index (ASI)

    Baseline, 3 month, 6 month

  • General Anxiety Disorder (GAD-7)

    Baseline, 3 month, 6 month

  • Patient Health Questionnaire (PHQ-9)

    Baseline, 3 month, 6 month

  • PTSD Checklist for the DSM-V (Diagnostic and Statistical Manual)

    Baseline, 3 month, 6 month

  • +16 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

This arm consists of approximately 8-10 modules lasting approximately one hour and consisting of psychoeducation and core components including communication, problem solving, goal setting, and dealing with stress, tailored to families with experiences of homelessness and parental substance use.

Behavioral: Adapted Family Resilience Intervention

Interventions

The program consists of approximately 8-10 modules lasting approximately one hour. Sessions focus on psychoeducation and key resilience skills.

Intervention

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Family has a history of homelessness within the past two years (homelessness defined by the Department of Health and Human Services definition)
  • Parent/guardian/caregiver has custody of and cares for a youth between the ages of 8-17
  • Both youth and parent/guardian/caregiver are able to take part in an 8 module session intervention

You may not qualify if:

  • Has taken part in a Families OverComing Under Stress (FOCUS) intervention previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Study Officials

  • Roya Ijadi-Maghsoodi, MD, MSHPM

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Residence

Study Record Dates

First Submitted

January 22, 2020

First Posted

February 17, 2020

Study Start

February 19, 2020

Primary Completion

April 3, 2023

Study Completion

April 3, 2023

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations