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Not yet recruiting NCT07519759

Recovery Inspired Support Engagement (RISE) Pilot

No phase Interventional Support Persons Family Members Chosen Family Romantic Partners

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ITC.
Who it may be relevant to
Registry conditions: Support Persons, Family Members, Chosen Family, Romantic Partners. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Program Completion [Time frame: From enrollment to the end of the program (12 weeks).]
Secondary outcome measures (1)
  • Mean Session Satisfaction [Time frame: From enrollment to the end of the program (12 weeks).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07519759 · 2026P000880 · 1R61DA064788-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗