Testing Effectiveness of the Community Reinforcement Approach and Family Training (CRAFT) With Am… (NCT03203889) | Clinical Trial Compass
CompletedNot Applicable
Testing Effectiveness of the Community Reinforcement Approach and Family Training (CRAFT) With American Indians
United States45 participantsStarted 2017-06-27
Plain-language summary
It is important to address the substantial substance-related health disparities of American Indians (AI). This project aims to examine the effectiveness of a culturally tailored Community Reinforcement and Family Training (CRAFT) approach and Twelve-step facilitation with Concerned Significant Others (TSF-CSOs) among AIs to increase engagement of treatment refusing individuals into treatment/healing and to reduce distress of their loved ones. Study hypotheses are that (1) CRAFT will result in higher numbers of people entering treatment for substance use disorders than will TSF-CSO, (2) both groups will yield similar improvements in the family member's functioning, and (3) we will explore potential factors of the treatments to see which aspects of the treatment are most important and to test which characteristics of the clients impact the outcomes for better or worse. This knowledge may impact dissemination and diffusion efforts for CRAFT-AI and other evidence-based treatments among AIs and other culturally diverse groups.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. are at least 18 years of age;
. are a member of this AI tribe and living within 60 mile radius of the research or treatment site (i.e., the reservation);
. are able to converse fluently in English (RA will read questions if English literacy is poor and may speak in their Native language with Native speakers);
. are concerned about an AI with an SUD (IP) who is an intimate partner, relative (sanguine or not), or close friend;
. have face-to-face contact with the IP at least 40% of the past 90 days, excluding any time in detention, with no planned change such as separation or moving out;
. describe the IP behavior as consistent with Diagnostic and Statistical Manual of Mental Disorders SUD criteria 5th edition, DSM-5;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identified person with addiction's treatment entry or seeking traditional healing
. report that the IP refused to seek treatment and had not received any treatment (other than detoxification) or traditional healing for SUD problems in the past 90 days, nor was court mandated to treatment.
Exclusion criteria
. meets criteria for injectable drug SUD (but other SUD allowable)
. shows signs of unremitted psychosis, any serious psychiatric condition, or cognitive impairment that could interfere with the CSO's ability to understand and participate in treatment;
. intends to seek more than 6 hours of additional behavioral health treatment (not including substance abuse treatment) in the next 3 months;
. has an IP who has received a Johnson Institute Intervention within the prior 3 years; or
. reports severe domestic violence (including use of a weapon or injury requiring hospitalization) at the hand of the IP.