Engaging Family Members During Early SUD Treatment: A Hybrid Trial
2 other identifiers
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 6, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
Study Completion
Last participant's last visit for all outcomes
March 31, 2027
May 14, 2026
May 1, 2026
7 months
May 6, 2026
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attendance
Attend at least 1 eINSPIRE session
2 months after baseline
Secondary Outcomes (3)
Feasibility of Engagement Strategies
6 months from enrollment
Acceptability of Engagement Strategies
6 months from enrollment
Appropriateness of Engagement Strategies
6 months from enrollment
Study Arms (16)
Aim 2: Arm 1
ACTIVE COMPARATORAll 4 Engagement Strategies
Aim 2: Arm 2
ACTIVE COMPARATORStrategies 1-3
Aim 2: Arm 3
ACTIVE COMPARATORStrategies 1-2
Aim 2: Arm 4
ACTIVE COMPARATORStrategies 2-4
Aim 2: Arm 5
ACTIVE COMPARATORStrategies 3-4
Aim 2: Arm 6
ACTIVE COMPARATORStrategies 1 \& 3
Aim 2: Arm 7
ACTIVE COMPARATORStrategies 2 \& 4
Aim 2: Arm 8
ACTIVE COMPARATORStrategies 1, 2 \& 4
Aim 2: Arm 9
ACTIVE COMPARATORStrategies 2-3
Aim 2: Arm 10
ACTIVE COMPARATORStrategies 1, 3 \& 4
Aim 2: Arm 11
ACTIVE COMPARATORStrategy 1
Aim 2: Arm 12
ACTIVE COMPARATORStrategy 2
Aim 2: Arm 13
ACTIVE COMPARATORStrategy 3
Aim 2: Arm 14
ACTIVE COMPARATORStrategy 4
Aim 2: Arm 15
ACTIVE COMPARATORStrategy 1 \& 4
Aim 2: Arm 16
PLACEBO COMPARATORNo Strategies
Interventions
Engagement Strategy
Engagement Strategy
Engagement Strategy
Engagement Strategy
Eligibility Criteria
You may qualify if:
- 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:
- 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:
- Counselor/Clinician providing care at our partner clinic for SUD
You may not qualify if:
- Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
- Does not understand English fluently
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
- RANDcollaborator
- Northern California Institute of Research and Educationcollaborator
- Family Health Centers of San Diegocollaborator
Study Sites (1)
Family Health Centers of San Diego
San Diego, California, 92012, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Osilla, PhD
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 6, 2026
First Posted
May 12, 2026
Study Start (Estimated)
July 15, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
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.