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NCT Number: NCT07519759

Recovery Inspired Support Engagement (RISE) Pilot

The goal of this clinical trial is to learn if a 1-on-1 support program is easy to complete and acceptable for people supporting loved ones who have recently received treatment for substance use. The main questions it aims to answer are:

How many people complete the program? How satisfied are people with the program?

Participants will:

Complete weekly telehealth sessions for 12 weeks Complete surveys/interviews at the beginning, in the middle (~week 6), at the end of the program (~week 12), and 12-weeks after the end of the program Complete a focus group or interview

Recruiting

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Key information

Conditions

Support Persons Caregivers Chemically-Induced Disorders Chosen Family Family Members Friends Mental Disorders Romantic Partners Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The program aims to improve support person well-being, social recovery capital, and their loved one's substance use outcomes. Information from support persons and loved ones with a substance use disorder will be collected for program feedback and hypothesis generating purposes. Target enrollment for the clinical trial is 15 pairs of support persons and their loved one. We will plan to recruit 18 pairs of participants in case some people may not complete the study (~15%). Total planned enrollment of support persons (n=18) and their loved ones (n=18) is N=36.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Inclusion Criteria for Support Persons:
  • Ages 18+.
  • Having a loved one who participated in an inpatient or residential substance use disorder program in the past 30 days, as reported by loved one, support person, clinician, or chart review.
  • Interest in supporting the loved one's recovery from substance use.
  • At least 4 days per month virtual or in-person contact per month with the loved one.
  • Access to a computer with internet or mobile phone with video conferencing capabilities.
  • Ability to provide written informed consent.
  • Speak and read English.
  • Inclusion Criteria for Loved Ones:
  • Ages 18+.
  • Participated in an inpatient or residential substance use disorder program in the past 30 days, as reported by self, support person, clinician, or chart review.
  • At least 4 days per month virtual or in-person contact per month with the support person.
  • Access to a computer with internet or mobile phone with video conferencing capabilities.
  • Ability to provide written informed consent.
  • Speak and read English.

Exclusion criteria

  • Exclusion Criteria for Support Persons:
  • DSM-5 moderate or severe substance use disorder in the past year.
  • History of domestic violence with the loved one that would interfere with the ability to safely follow through with the intervention plan.
  • Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the intervention plan.
  • Prior participation of a support person of the loved one in an ITC-related research study.
  • Significant prior experience with ITC or CRAFT (e.g., having completed an ITC-related training workshop or course prior to study enrollment)
  • Exclusion Criteria for Loved Ones: N/A

Treatment and study plan

ITC

Behavioral

ITC is a behavioral intervention delivered via telehealth. The coaching session topics include skills to help with understanding, awareness, and action. The intervention is designed for support persons of individuals living with a substance use disorder.

Other names: Invitation to Change (ITC)

Primary outcomes

  1. Program Completion

    Time frame: From enrollment to the end of the program (12 weeks).

    Proportion of participants completing 12-session program

Secondary outcomes

  1. Mean Session Satisfaction

    Time frame: From enrollment to the end of the program (12 weeks).

    Participants will report weekly satisfaction (helpfulness) ratings following each session on the Session Survey. Ratings will range from 1 (poor) to 5 (excellent).

Study contacts

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

Julie M McCarthy, PhD

CONTACT

[email protected]

16178553521

Roger D Weiss, PhD

CONTACT

[email protected]

617-855-2242

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: (RISE)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Sep 15, 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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