NCT07519759

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Feb 2028

First Submitted

Initial submission to the registry

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 3, 2026

Last Update Submit

April 23, 2026

Conditions

Support PersonsFamily MembersChosen FamilyFriendsCaregiversSubstance Use DisordersRomantic Partners

Keywords

Support PersonsFriendsSubstance Use DisordersAlcoholSubstance Use (Drugs, Alcohol)Social SupportRecoveryInvitation to ChangeITCRomantic PartnersChosen FamilyFamily MembersCaregivers

Outcome Measures

Primary Outcomes (1)

  • Program Completion

    Proportion of participants completing 12-session program

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

Secondary Outcomes (1)

  • Mean Session Satisfaction

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

Study Arms (1)

Invitation to Change (ITC)

EXPERIMENTAL

12 weekly individual sessions of 60-minute ITC coaching

Behavioral: ITC

Interventions

ITCBEHAVIORAL

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.

Also known as: Invitation to Change (ITC)
Invitation to Change (ITC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Central Study Contacts

Julie M McCarthy, PhD

CONTACT

16178553521jmccarthy@mclean.harvard.edu

Roger D Weiss, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Psychologist / Assistant Professor of Psychology

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 9, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share