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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61DA064789-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| RAND | OTHER |
| Northern California Institute of Research and Education | OTHER |
| Family Health Centers of San Diego |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 2: Arm 1 | Active Comparator | All 4 Engagement Strategies |
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| Aim 2: Arm 2 | Active Comparator | Strategies 1-3 |
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| Aim 2: Arm 3 | Active Comparator | Strategies 1-2 |
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| Aim 2: Arm 4 | Active Comparator | Strategies 2-4 |
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| Aim 2: Arm 5 | Active Comparator | Strategies 3-4 |
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| Aim 2: Arm 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engagement Strategy 1 | Behavioral | Engagement Strategy |
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| Measure | Description | Time Frame |
|---|---|---|
| Attendance | Attend at least 1 eINSPIRE session | 2 months after baseline |
| 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 |
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FAMILY MEMBERS:
Inclusion Criteria:
PATIENTS:
Inclusion Criteria:
CLINIC PROVIDERS:
Inclusion Criteria:
Exclusion Criteria (ALL):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kat Nameth, MS | Contact | 650-542-9699 | knameth@stanford.edu | |
| Kirsten Becker, MPH | Contact | (866) 697-5620 | becker@rand.org |
| Name | Affiliation | Role |
|---|---|---|
| Karen Osilla, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Health Centers of San Diego | San Diego | California | 92012 | United States |
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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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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| OTHER |
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
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| Active Comparator |
Strategies 1 & 3 |
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| Aim 2: Arm 7 | Active Comparator | Strategies 2 & 4 |
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| Aim 2: Arm 8 | Active Comparator | Strategies 1, 2 & 4 |
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| Aim 2: Arm 9 | Active Comparator | Strategies 2-3 |
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| Aim 2: Arm 10 | Active Comparator | Strategies 1, 3 & 4 |
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| Aim 2: Arm 11 | Active Comparator | Strategy 1 |
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| Aim 2: Arm 12 | Active Comparator | Strategy 2 |
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| Aim 2: Arm 13 | Active Comparator | Strategy 3 |
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| Aim 2: Arm 14 | Active Comparator | Strategy 4 |
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| Aim 2: Arm 15 | Active Comparator | Strategy 1 & 4 |
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| Aim 2: Arm 16 | Placebo Comparator | No Strategies |
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| Engagement Strategy 2 | Behavioral | Engagement Strategy |
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| Engagement Strategy 3 | Behavioral | Engagement Strategy |
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| Engagement Strategy 4 | Behavioral | Engagement Strategy |
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| Placebo | Behavioral | No engagement strategies |
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| 6 months from enrollment |
| Appropriateness of Engagement Strategies | Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness | 6 months from enrollment |
| D001519 |
| Behavior |