Engaging Family Members During Early SUD Treatment: A Hybrid Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use Disorder (SUD)
• Intervention / Treatment: Behavioral: Engagement Strategy 1; Behavioral: Engagement Strategy 2; Behavioral: Engagement Strategy 3; Behavioral: Engagement Strategy 4; Behavioral: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kat Nameth, MS; Phone Number: 650-542-9699; Email: knameth@stanford.edu
• Study Contact Backup: Name: Kirsten Becker, MPH; Phone Number: (866) 697-5620; Email: becker@rand.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92012
      • Family Health Centers of San Diego
      • Contact: Joe Sepulveda, MD; Phone Number: (619) 515-2300; Email: joes@fhcsd.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aim 2: Arm 1; All 4 Engagement Strategies	Behavioral: Engagement Strategy 1; Engagement Strategy; Behavioral: Engagement Strategy 2; Engagement Strategy; Behavioral: Engagement Strategy 3; Engagement Strategy; Behavioral: Engagement Strategy 4; Engagement Strategy
Active Comparator: Aim 2: Arm 2; Strategies 1-3	Behavioral: Engagement Strategy 1; Engagement Strategy; Behavioral: Engagement Strategy 2; Engagement Strategy; Behavioral: Engagement Strategy 3; Engagement Strategy
Active Comparator: Aim 2: Arm 3; Strategies 1-2	Behavioral: Engagement Strategy 1; Engagement Strategy; Behavioral: Engagement Strategy 2; Engagement Strategy
Active Comparator: Aim 2: Arm 4; Strategies 2-4	Behavioral: Engagement Strategy 2; Engagement Strategy; Behavioral: Engagement Strategy 3; Engagement Strategy; Behavioral: Engagement Strategy 4; Engagement Strategy
Active Comparator: Aim 2: Arm 5; Strategies 3-4	Behavioral: Engagement Strategy 3; Engagement Strategy; Behavioral: Engagement Strategy 4; Engagement Strategy
Active Comparator: Aim 2: Arm 6; Strategies 1 & 3	Behavioral: Engagement Strategy 1; Engagement Strategy; Behavioral: Engagement Strategy 3; Engagement Strategy
Active Comparator: Aim 2: Arm 7; Strategies 2 & 4	Behavioral: Engagement Strategy 2; Engagement Strategy; Behavioral: Engagement Strategy 4; Engagement Strategy
Active Comparator: Aim 2: Arm 8; Strategies 1, 2 & 4	Behavioral: Engagement Strategy 1; Engagement Strategy; Behavioral: Engagement Strategy 2; Engagement Strategy; Behavioral: Engagement Strategy 4; Engagement Strategy
Active Comparator: Aim 2: Arm 9; Strategies 2-3	Behavioral: Engagement Strategy 2; Engagement Strategy; Behavioral: Engagement Strategy 3; Engagement Strategy
Active Comparator: Aim 2: Arm 10; Strategies 1, 3 & 4	Behavioral: Engagement Strategy 1; Engagement Strategy; Behavioral: Engagement Strategy 3; Engagement Strategy; Behavioral: Engagement Strategy 4; Engagement Strategy
Active Comparator: Aim 2: Arm 11; Strategy 1	Behavioral: Engagement Strategy 1; Engagement Strategy
Active Comparator: Aim 2: Arm 12; Strategy 2	Behavioral: Engagement Strategy 2; Engagement Strategy
Active Comparator: Aim 2: Arm 13; Strategy 3	Behavioral: Engagement Strategy 3; Engagement Strategy
Active Comparator: Aim 2: Arm 14; Strategy 4	Behavioral: Engagement Strategy 4; Engagement Strategy
Active Comparator: Aim 2: Arm 15; Strategy 1 & 4	Behavioral: Engagement Strategy 1; Engagement Strategy; Behavioral: Engagement Strategy 4; Engagement Strategy
Placebo Comparator: Aim 2: Arm 16; No Strategies	Behavioral: Placebo; No engagement strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	Attend at least 1 eINSPIRE session	2 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Engagement Strategies	Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility	6 months from enrollment
Acceptability of Engagement Strategies	Assessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability	6 months from enrollment
Appropriateness of Engagement Strategies	Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness	6 months from enrollment

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute on Drug Abuse (NIDA); Northern California Institute of Research and Education; RAND; Family Health Centers of San Diego
• Investigators: Principal Investigator: Karen Osilla, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: addiction; substance use; substance use treatment; CRAFT; family members; sud; support persons
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Substance-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: IRB-86357; 1R61DA064789-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Aggregate quantitative survey data from Aim 2 will still be provided. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) for the NIMH Data Archive (NDA) will be collected for each subject. Participant-level data, survey instruments, and measurement descriptions will be deposited to NIMH Data Archive in accordance with the NIH Data Management and Sharing Policy effective January 24, 2023.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No