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NCT Number: NCT07579299

Engaging Family Members During Early SUD Treatment: A Hybrid Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Engagement Strategy 1

Behavioral

Engagement Strategy

Engagement Strategy 2

Behavioral

Engagement Strategy

Engagement Strategy 3

Behavioral

Engagement Strategy

Engagement Strategy 4

Behavioral

Engagement Strategy

Placebo

Behavioral

No engagement strategies

Primary outcomes

  1. Attendance

    Time frame: 2 months after baseline

    Attend at least 1 eINSPIRE session

Secondary outcomes

  1. Feasibility of Engagement Strategies

    Time frame: 6 months from enrollment

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

  2. Acceptability of Engagement Strategies

    Time frame: 6 months from enrollment

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

  3. Appropriateness of Engagement Strategies

    Time frame: 6 months from enrollment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kat Nameth, MS

CONTACT

[email protected]

650-542-9699

Kirsten Becker, MPH

CONTACT

[email protected]

(866) 697-5620

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Family Health Centers of San Diego
  • National Institute on Drug Abuse (NIDA)
  • Northern California Institute of Research and Education
  • RAND

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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