Skip to content

Engaging Family Members During Early SUD Treatment: A Hybrid Trial

Engaging Family Members During Early SUD Treatment: A Hybrid Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07579299
Enrollment
100
Registered
2026-05-12
Start date
2026-07-15
Completion date
2027-03-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorder (SUD)

Keywords

sud, CRAFT, addiction, substance use, substance use treatment, family members, support persons

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.

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

BEHAVIORALEngagement Strategy 1

Engagement Strategy

BEHAVIORALEngagement Strategy 2

Engagement Strategy

BEHAVIORALEngagement Strategy 3

Engagement Strategy

BEHAVIORALEngagement Strategy 4

Engagement Strategy

BEHAVIORALPlacebo

No engagement strategies

Sponsors

Stanford University
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
RAND
CollaboratorOTHER
Northern California Institute of Research and Education
CollaboratorOTHER
Family Health Centers of San Diego
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Support persons will be randomly assigned to one of the groups defined by the presence or absence of up to four engagement strategies combined with the CRAFT intervention under a fractional factorial design. To maintain approximately equal allocation across each intervention arm in the optimization trial, investigators will use permuted block randomization with random size blocks

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Attendance2 months after baselineAttend at least 1 eINSPIRE session

Secondary

MeasureTime frameDescription
Feasibility of Engagement Strategies6 months from enrollmentAssessed via the Intervention Usability Scale, score of 70+ indicates feasibility
Acceptability of Engagement Strategies6 months from enrollmentAssessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability
Appropriateness of Engagement Strategies6 months from enrollmentAssessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness

Countries

United States

Contacts

CONTACTKat Nameth, MS
knameth@stanford.edu650-542-9699
CONTACTKirsten Becker, MPH
becker@rand.org(866) 697-5620
PRINCIPAL_INVESTIGATORKaren Osilla, PhD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026