Recruiting

Support Program

Sponsor:

Mclean Hospital

Code:

NCT07519759

Conditions

Support Persons

Family Members

Chosen Family

Romantic Partners

Friends

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ITC

Study Details

Brief summary:

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

Conditions

Support Persons

Family Members

Chosen Family

Romantic Partners

Friends

Study ID

NCT07519759

Start date

Sep 14, 2026

Status verified date

Sep, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Invitation to Change (ITC)

12 weekly individual sessions of 60-minute ITC coaching

Interventions

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.

Primary outcome measure

  • Program Completion [ Time Frame: From enrollment to the end of the program (12 weeks). ]

Central Contacts and Locations

Central contacts

Julie M McCarthy, PhD

16178553521jmccarthy@mclean.harvard.edu

Roger D Weiss, PhD

617-855-2242rweiss@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Julie M McCarthy, PhD

617-855-3521jmccarthy@mclean.harvard.edu

Matthew (Mattie) Doherty, BA

617-855-2569risestudy@mclean.harvard.edu

Principal Investigator:

Julie M. McCarthy, PhD

More Information

Sponsor

Mclean Hospital

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Support Persons
  • Friends
  • Substance Use Disorders
  • Alcohol
  • Substance Use (Drugs, Alcohol)
  • Social Support
  • Recovery
  • Invitation to Change
  • ITC
  • Romantic Partners
  • Chosen Family
  • Family Members
  • Caregivers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2026-09-15.