Substance Use Disorder (SUD)NCT07579299
Engaging Family Members During Early SUD Treatment: A Hybrid Trial
A study testing Engagement Strategy 1, Engagement Strategy 2 and Engagement Strategy 3 in people with Substance Use Disorder (SUD), run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Engagement Strategy 1, Engagement Strategy 2 and Engagement Strategy 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- PATIENTS:
- 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:
- Counselor/Clinician providing care at our partner clinic for SUD
Who cannot join
- Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
- Does not understand English fluently
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Family Health Centers of San Diego
San Diego, California, 92012
Joe Sepulveda, MD, (619) 515-2300, joes@fhcsd.org
About this study
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.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- Engagement Strategy 1, Engagement Strategy 2, Engagement Strategy 3, Engagement Strategy 4, Placebo
- Keywords
- sud, CRAFT, addiction, substance use, substance use treatment, family members, support persons
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engagement Strategy 1Behavioural
Engagement Strategy
Engagement Strategy 2Behavioural
Engagement Strategy
Engagement Strategy 3Behavioural
Engagement Strategy
Engagement Strategy 4Behavioural
Engagement Strategy
PlaceboBehavioural
No engagement strategies
| Study group | Role | What they receive |
|---|---|---|
| Aim 2: Arm 1 | Active comparator | All 4 Engagement Strategies Receives: Behavioral: Engagement Strategy 1; Behavioral: Engagement Strategy 2; Behavioral: Engagement Strategy 3; Behavioral: Engagement Strategy 4 |
| Aim 2: Arm 2 | Active comparator | Strategies 1-3 Receives: Behavioral: Engagement Strategy 1; Behavioral: Engagement Strategy 2; Behavioral: Engagement Strategy 3 |
| Aim 2: Arm 3 | Active comparator | Strategies 1-2 Receives: Behavioral: Engagement Strategy 1; Behavioral: Engagement Strategy 2 |
| Aim 2: Arm 4 | Active comparator | Strategies 2-4 Receives: Behavioral: Engagement Strategy 2; Behavioral: Engagement Strategy 3; Behavioral: Engagement Strategy 4 |
| Aim 2: Arm 5 | Active comparator | Strategies 3-4 Receives: Behavioral: Engagement Strategy 3; Behavioral: Engagement Strategy 4 |
| Aim 2: Arm 6 | Active comparator | Strategies 1 \& 3 Receives: Behavioral: Engagement Strategy 1; Behavioral: Engagement Strategy 3 |
| Aim 2: Arm 7 | Active comparator | Strategies 2 \& 4 Receives: Behavioral: Engagement Strategy 2; Behavioral: Engagement Strategy 4 |
| Aim 2: Arm 8 | Active comparator | Strategies 1, 2 \& 4 Receives: Behavioral: Engagement Strategy 1; Behavioral: Engagement Strategy 2; Behavioral: Engagement Strategy 4 |
| Aim 2: Arm 9 | Active comparator | Strategies 2-3 Receives: Behavioral: Engagement Strategy 2; Behavioral: Engagement Strategy 3 |
| Aim 2: Arm 10 | Active comparator | Strategies 1, 3 \& 4 Receives: Behavioral: Engagement Strategy 1; Behavioral: Engagement Strategy 3; Behavioral: Engagement Strategy 4 |
| Aim 2: Arm 11 | Active comparator | Strategy 1 Receives: Behavioral: Engagement Strategy 1 |
| Aim 2: Arm 12 | Active comparator | Strategy 2 Receives: Behavioral: Engagement Strategy 2 |
| Aim 2: Arm 13 | Active comparator | Strategy 3 Receives: Behavioral: Engagement Strategy 3 |
| Aim 2: Arm 14 | Active comparator | Strategy 4 Receives: Behavioral: Engagement Strategy 4 |
| Aim 2: Arm 15 | Active comparator | Strategy 1 \& 4 Receives: Behavioral: Engagement Strategy 1; Behavioral: Engagement Strategy 4 |
| Aim 2: Arm 16 | Placebo comparator | No Strategies Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
Attend at least 1 eINSPIRE session
Measured: 2 months after baseline
Secondary outcomes (3)
Feasibility of Engagement Strategies
Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
Measured: 6 months from enrollment
Acceptability of Engagement Strategies
Assessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability
Measured: 6 months from enrollment
Appropriateness of Engagement Strategies
Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
Measured: 6 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 Jul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), RAND, Northern California Institute of Research and Education, Family Health Centers of San Diego
- Responsible party
- Principal investigator, Karen Osilla, Stanford University
- Investigators
- Karen Osilla, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579299
- Sponsor's protocol ID
- IRB-86357
- Other IDs
- 1R61DA064789-01
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Family Members During Early SUD Treatment: A Hybrid Trial
- ClinicalTrials.gov ID
- NCT07579299
- Acronym / sponsor ID
- IRB-86357
- Conditions
- Substance Use Disorder (SUD)
- Keywords
- sud, CRAFT, addiction, substance use, substance use treatment, family members, support persons
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), RAND, Northern California Institute of Research and Education, Family Health Centers of San Diego
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
- 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
| Arm | Type | Receives |
|---|---|---|
| Aim 2: Arm 1 | Active comparator | Behavioral: Engagement Strategy 1, Behavioral: Engagement Strategy 2, Behavioral: Engagement Strategy 3, Behavioral: Engagement Strategy 4All 4 Engagement Strategies |
| Aim 2: Arm 2 | Active comparator | Behavioral: Engagement Strategy 1, Behavioral: Engagement Strategy 2, Behavioral: Engagement Strategy 3Strategies 1-3 |
| Aim 2: Arm 3 | Active comparator | Behavioral: Engagement Strategy 1, Behavioral: Engagement Strategy 2Strategies 1-2 |
| Aim 2: Arm 4 | Active comparator | Behavioral: Engagement Strategy 2, Behavioral: Engagement Strategy 3, Behavioral: Engagement Strategy 4Strategies 2-4 |
| Aim 2: Arm 5 | Active comparator | Behavioral: Engagement Strategy 3, Behavioral: Engagement Strategy 4Strategies 3-4 |
| Aim 2: Arm 6 | Active comparator | Behavioral: Engagement Strategy 1, Behavioral: Engagement Strategy 3Strategies 1 \& 3 |
| Aim 2: Arm 7 | Active comparator | Behavioral: Engagement Strategy 2, Behavioral: Engagement Strategy 4Strategies 2 \& 4 |
| Aim 2: Arm 8 | Active comparator | Behavioral: Engagement Strategy 1, Behavioral: Engagement Strategy 2, Behavioral: Engagement Strategy 4Strategies 1, 2 \& 4 |
| Aim 2: Arm 9 | Active comparator | Behavioral: Engagement Strategy 2, Behavioral: Engagement Strategy 3Strategies 2-3 |
| Aim 2: Arm 10 | Active comparator | Behavioral: Engagement Strategy 1, Behavioral: Engagement Strategy 3, Behavioral: Engagement Strategy 4Strategies 1, 3 \& 4 |
| Aim 2: Arm 11 | Active comparator | Behavioral: Engagement Strategy 1Strategy 1 |
| Aim 2: Arm 12 | Active comparator | Behavioral: Engagement Strategy 2Strategy 2 |
| Aim 2: Arm 13 | Active comparator | Behavioral: Engagement Strategy 3Strategy 3 |
| Aim 2: Arm 14 | Active comparator | Behavioral: Engagement Strategy 4Strategy 4 |
| Aim 2: Arm 15 | Active comparator | Behavioral: Engagement Strategy 1, Behavioral: Engagement Strategy 4Strategy 1 \& 4 |
| Aim 2: Arm 16 | Placebo comparator | Behavioral: PlaceboNo Strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
- Does not understand English fluently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engagement Strategy 1Engagement Strategy | Behavioural | Aim 2: Arm 1, Aim 2: Arm 10, Aim 2: Arm 11, Aim 2: Arm 15, Aim 2: Arm 2, Aim 2: Arm 3, Aim 2: Arm 6, Aim 2: Arm 8 |
| Engagement Strategy 2Engagement Strategy | Behavioural | Aim 2: Arm 1, Aim 2: Arm 12, Aim 2: Arm 2, Aim 2: Arm 3, Aim 2: Arm 4, Aim 2: Arm 7, Aim 2: Arm 8, Aim 2: Arm 9 |
| Engagement Strategy 3Engagement Strategy | Behavioural | Aim 2: Arm 1, Aim 2: Arm 10, Aim 2: Arm 13, Aim 2: Arm 2, Aim 2: Arm 4, Aim 2: Arm 5, Aim 2: Arm 6, Aim 2: Arm 9 |
| Engagement Strategy 4Engagement Strategy | Behavioural | Aim 2: Arm 1, Aim 2: Arm 10, Aim 2: Arm 14, Aim 2: Arm 15, Aim 2: Arm 4, Aim 2: Arm 5, Aim 2: Arm 7, Aim 2: Arm 8 |
| PlaceboNo engagement strategies | Behavioural | Aim 2: Arm 16 |
Primary outcome
Attendance
Time frame: 2 months after baseline
Attend at least 1 eINSPIRE session
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Osilla, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engagement Strategy 1, Engagement Strategy 2 and Engagement Strategy 3 in people with Substance Use Disorder (SUD), run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kat Nameth, MS (650-542-9699, knameth@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: 2 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.