Recovery Inspired Support Engagement (RISE) Pilot ((RISE))

April 23, 2026 updated by: Julie McCarthy, Ph.D., Mclean Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Invitation to Change (ITC)
12 weekly individual sessions of 60-minute ITC coaching
Behavioral: ITC
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Completion
Time Frame: From enrollment to the end of the program (12 weeks).
Proportion of participants completing 12-session program
From enrollment to the end of the program (12 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the end of the program (12 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P000880
  • 1R61DA064788-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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