Recovery Inspired Support Engagement (RISE) Pilot

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Mean Session Satisfaction [Срок оценки: From enrollment to the end of the program (12 weeks).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07519759 · 2026P000880 · 1R61DA064788-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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