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Not yet recruitingNCT07579299Updated May 14, 2026

Engaging Family Members During Early SUD Treatment: A Hybrid Trial

An interventional study of Engagement Strategy 1 and Engagement Strategy 2 in Substance Use Disorder (SUD), sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Substance Use Disorder (SUD)

Keywords

  • sud
  • CRAFT
  • addiction
  • substance use
  • substance use treatment
  • family members
  • support persons
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's planned enrollment of 100 is close to the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Browse Stanford University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Aim 2: Arm 1

    All 4 Engagement Strategies

    Behavioral: Engagement Strategy 1 · Behavioral: Engagement Strategy 2 · Behavioral: Engagement Strategy 3 · Behavioral: Engagement Strategy 4

  • Active comparator
    Aim 2: Arm 2

    Strategies 1-3

    Behavioral: Engagement Strategy 1 · Behavioral: Engagement Strategy 2 · Behavioral: Engagement Strategy 3

  • Active comparator
    Aim 2: Arm 3

    Strategies 1-2

    Behavioral: Engagement Strategy 1 · Behavioral: Engagement Strategy 2

  • Active comparator
    Aim 2: Arm 4

    Strategies 2-4

    Behavioral: Engagement Strategy 2 · Behavioral: Engagement Strategy 3 · Behavioral: Engagement Strategy 4

  • Active comparator
    Aim 2: Arm 5

    Strategies 3-4

    Behavioral: Engagement Strategy 3 · Behavioral: Engagement Strategy 4

  • Active comparator
    Aim 2: Arm 6

    Strategies 1 \& 3

    Behavioral: Engagement Strategy 1 · Behavioral: Engagement Strategy 3

  • Active comparator
    Aim 2: Arm 7

    Strategies 2 \& 4

    Behavioral: Engagement Strategy 2 · Behavioral: Engagement Strategy 4

  • Active comparator
    Aim 2: Arm 8

    Strategies 1, 2 \& 4

    Behavioral: Engagement Strategy 1 · Behavioral: Engagement Strategy 2 · Behavioral: Engagement Strategy 4

  • Active comparator
    Aim 2: Arm 9

    Strategies 2-3

    Behavioral: Engagement Strategy 2 · Behavioral: Engagement Strategy 3

  • Active comparator
    Aim 2: Arm 10

    Strategies 1, 3 \& 4

    Behavioral: Engagement Strategy 1 · Behavioral: Engagement Strategy 3 · Behavioral: Engagement Strategy 4

  • Active comparator
    Aim 2: Arm 11

    Strategy 1

    Behavioral: Engagement Strategy 1

  • Active comparator
    Aim 2: Arm 12

    Strategy 2

    Behavioral: Engagement Strategy 2

  • Active comparator
    Aim 2: Arm 13

    Strategy 3

    Behavioral: Engagement Strategy 3

  • Active comparator
    Aim 2: Arm 14

    Strategy 4

    Behavioral: Engagement Strategy 4

  • Active comparator
    Aim 2: Arm 15

    Strategy 1 \& 4

    Behavioral: Engagement Strategy 1 · Behavioral: Engagement Strategy 4

  • Placebo comparator
    Aim 2: Arm 16

    No Strategies

    Behavioral: Placebo

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

06

What researchers measure

Primary outcomes

  1. Attendance

    Attend at least 1 eINSPIRE session

    Time frame: 2 months after baseline

Secondary outcomes

  1. Feasibility of Engagement Strategies

    Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility

    Time frame: 6 months from enrollment

  2. Acceptability of Engagement Strategies

    Assessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability

    Time frame: 6 months from enrollment

  3. Appropriateness of Engagement Strategies

    Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness

    Time frame: 6 months from enrollment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.

Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 6 months is below that.

Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2026
First posted
May 12, 2026
StartEst.
Jul 15, 2026
Primary completionEst.
Jan 31, 2027
CompletionEst.
Mar 31, 2027
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07579299
Lead sponsor
Stanford University
Collaborators
National Institute on Drug Abuse (NIDA), RAND, Northern California Institute of Research and Education, Family Health Centers of San Diego
Responsible party
Karen Osilla (Principal Investigator, Stanford University) — Principal investigator
First posted
May 12, 2026
Start date
Jul 15, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
May 14, 2026

Study contacts

Kat Nameth, MS
Contact
knameth@stanford.edu
650-542-9699
Kirsten Becker, MPH
Contact
becker@rand.org
(866) 697-5620
Karen Osilla, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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