Support Persons(RISE)NCT07519759
Recovery Inspired Support Engagement (RISE) Pilot
A study testing ITC in people with Support Persons and Family Members, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Support Persons, Family Members, Chosen Family
- What is being tested?
- ITC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Julie M McCarthy, PhD, 617-855-3521, jmccarthy@mclean.harvard.edu
Matthew (Mattie) Doherty, BA, 617-855-2569, risestudy@mclean.harvard.edu
About this study
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
Read the 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.
- Conditions
- Support Persons, Family Members, Chosen Family, Romantic Partners, Friends, Caregivers
- Being tested
- ITC
- 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
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITCBehavioural
Also called Invitation to Change (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.
| Study group | Role | What they receive |
|---|---|---|
| Invitation to Change (ITC) | Experimental | 12 weekly individual sessions of 60-minute ITC coaching Receives: Behavioral: ITC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Completion
Proportion of participants completing 12-session program
Measured: From enrollment to the end of the program (12 weeks).
Secondary outcomes (1)
Mean Session Satisfaction
Participants will report weekly satisfaction (helpfulness) ratings following each session on the Session Survey. Ratings will range from 1 (poor) to 5 (excellent).
Measured: From enrollment to the end of the program (12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start14 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Support PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Julie McCarthy, Ph.D., Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519759
- Sponsor's protocol ID
- 2026P000880
- Other IDs
- 1R61DA064788-01
- Acronym
- (RISE)
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Inspired Support Engagement (RISE) Pilot
- ClinicalTrials.gov ID
- NCT07519759
- Acronym / sponsor ID
- (RISE) / 2026P000880
- Conditions
- Support Persons, Family Members, Chosen Family, Romantic Partners, Friends, Caregivers
- Keywords
- Support Persons, Friends, Substance Use Disorders, Alcohol, Substance Use (Drugs, Alcohol), Social Support, Recovery, Invitation to Change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invitation to Change (ITC) | Experimental | Behavioral: ITC12 weekly individual sessions of 60-minute ITC coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITCAlso: Invitation to Change (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. | Behavioural | Invitation to Change (ITC) |
Primary outcome
Program Completion
Time frame: From enrollment to the end of the program (12 weeks).
Proportion of participants completing 12-session program
1 secondary outcome
Mean Session Satisfaction
Time frame: From enrollment to the end of the program (12 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITC in people with Support Persons and Family Members, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie M McCarthy, PhD (16178553521, jmccarthy@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Completion (time frame: From enrollment to the end of the program (12 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.