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Not yet recruiting NCT07579299

Engaging Family Members During Early SUD Treatment: A Hybrid Trial

No phase Interventional Substance Use Disorder (SUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Engagement Strategy 1, Engagement Strategy 2, Engagement Strategy 3, Engagement Strategy 4.
Who it may be relevant to
Registry conditions: Substance Use Disorder (SUD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this study is a fractional factorial optimization trial to optimize engagement in a CRAFT program for family members with loved ones in outpatient treatment for a substance use disorder. This study aims to identify family engagement strategies that are feasible, acceptable, and appropriate and effective in increasing family member initiation with CRAFT. Participants will complete an iterative, online process where they will evaluate and rank different engagement strategies to identify the most optimal in increasing engagement and then participate in an optimization trial to identify which strategies were most effective in increasing family member engagement.

Detailed description

Family members (FMs) of people with substance use disorder (SUD)-including biological, extended, or chosen family-face chronic stress and are at high risk for mental and physical health problems. The impact is worsened by stigma, guilt, shame, and self-blame that often accompany a loved one's substance use, leading to social isolation and uncertainty about how to support recovery. Although FMs are motivated to help with treatment navigation, many do not seek support for themselves. Programs like Community Reinforcement and Family Training (CRAFT) can support FMs and provide tools to improve their own lives while assisting their loved one's recovery. While CRAFT is well-established in community settings for increasing a family member's initiation into treatment, its applicability in clinical SUD settings is less clear. It remains unknown whether CRAFT can enhance patient treatment retention in clinical settings and whether FMs who might not seek care would participate.

To advance the science of engaging and supporting families impacted by SUD, investigators will (1) Conduct an iterative online process with FMs and clinic staff to identify potential family engagement strategies that community health centers (CHCs) can deliver that are effective, feasible, acceptable, and appropriate, and (2) Test those strategies using a fractional factorial trial.

Interventions

  • Behavioral Engagement Strategy 1
    Engagement Strategy
  • Behavioral Engagement Strategy 2
    Engagement Strategy
  • Behavioral Engagement Strategy 3
    Engagement Strategy
  • Behavioral Engagement Strategy 4
    Engagement Strategy
  • Behavioral Placebo
    No engagement strategies

Primary outcome measures

  • Attendance [Time frame: 2 months after baseline]
Secondary outcome measures (3)
  • Feasibility of Engagement Strategies [Time frame: 6 months from enrollment]
  • Acceptability of Engagement Strategies [Time frame: 6 months from enrollment]
  • Appropriateness of Engagement Strategies [Time frame: 6 months from enrollment]

Eligibility criteria

FAMILY MEMBERS:

Inclusion criteria

  • 18 years old or older
  • A parent, child, sibling, spouse/romantic partner, or other adult supporting a loved one who initiated SUD treatment in past 3 months
  • Cohabitating with their loved one
  • In frequent contact (in-person or virtual) with their loved one (at least 3x/week)
  • Not worried about potential physical harm from their loved one
  • Report no illicit drug use in the past year

PATIENTS:

Inclusion criteria

  • 18 years old or older
  • In frequent contact with a family member (at least 3x/week) that they cohabitate with
  • Have initiated substance use treatment in past 3 months

CLINIC PROVIDERS:

Inclusion criteria

  • Counselor/Clinician providing care at our partner clinic for SUD

Exclusion Criteria (ALL):

  • Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
  • Does not understand English fluently

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Family Health Centers of San Diego — San Diego

Identifiers

NCT: NCT07579299 · IRB-86357 · 1R61DA064789-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗