Testing Effectiveness of the Community Reinforcement Approach and Family Training (CRAFT) With American Indians

NCT03203889 | Completed DMC

• 2 other identifiers: 947549-9R34DA040064-01A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use Disorders; Family Members

Keywords

American Indians; Native Americans; Community Reinforcement Approach and Family Training; Nar-Anonymous Facilitation; Treatment Entry; Cultural adaptations; Spirituality

Outcome Measures

Primary Outcomes (1)

• Identified person with addiction's treatment entry or seeking traditional healing

  attending one session of formal substance use disorder treatment or one AI traditional healing session within 6 months of the CSO's 1st counseling session

  6 months post CSO baseline

Secondary Outcomes (7)

• Relationship functioning

  6 months post CSO baseline

• Concerned significant other functioning

  6 months post CSO baseline

• Concerned Significant Other functioning II

  6 months post CSO baseline

• Concerned Significant Other functioning III

  6 months post CSO baseline

• Concerned Significant Other functioning IV

  6 months post CSO baseline

Other Outcomes (1)

• effect sizes

  6 months post CSO baseline

Study Arms (2)

CRAFT-AI

EXPERIMENTAL

Behavioral intervention: CRAFT-AI will include a maximum of 12 CSO individual counseling sessions will be provided. A functional analysis of the IP's substance use helps to identify triggers and both positive and negative consequences of use. The CSO brainstorms and decides upon ways to sever the connection between triggers and substance use, in part by introducing alternative non-substance related positive activities. In addition, the CSO and counselor collaboratively determine how to safely allow the IP to experience negative consequences due to the substance use, thereby making it less appealing for the IP to continue to use. The CSO also brainstorms and role-plays implementing the most effective and appropriate ways to suggest that the IP enter treatment.

Behavioral: CRAFT-AI

12-step facilitation for loved ones

ACTIVE COMPARATOR

12-step facilitation for loved ones or concerned significant others (TSF-CSO) intervention is delivered in 12 individual counseling sessions. There are 8 core components to this intervention that guide a CSO to understand that the identified person (IP) has a disease. The CSO is asked to surrender to a higher power because he or she is powerless to control the IP's substance use, and to lovingly detach from the IP. The CSO works to decrease enabling behaviors. Counselors will help the CSO to work the program of Nar/Al-Anon.

Behavioral: TSF-CSO

Interventions

CRAFT-AI BEHAVIORAL

Community Reinforcement Approach and Family Training (CRAFT) uses principles of operant conditioning to help a concerned significant other improve their own psychological functioning and influence the identified person with addiction to seek help

Also known as: CRAFT

CRAFT-AI

TSF-CSO BEHAVIORAL

In individual sessions, the counselor facilitates the CSO's affiliation and involvement in Nar-Anon or Al-Anon groups to work the steps.

Also known as: Nar-Anonymous Facilitation, Al-Anonymous Facilitation, Twelve-step Facilitation for Concerned Significant Others

12-step facilitation for loved ones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• are willing to participate in the research; and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Zuni Recovery Center

Zuni, New Mexico, 87327, United States

Location

Related Publications (1)

• Serier KN, Venner KL, Hernandez-Vallant A. The Condom Use Self-Efficacy Scale in Substance Use Disorder Treatment-Seeking American Indian Adults. Subst Use Misuse. 2021;56(13):2066-2073. doi: 10.1080/10826084.2021.1963988. Epub 2021 Sep 30.

  PMID: 34590538 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kamilla Venner, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Native American participants will be randomly assigned to one of the two arms: (1) culturally adapted CRAFT or (2) twelve-step facilitation for concerned significant others (TSF-CSO). Follow ups will be conducted at 3- and 6-months.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 29, 2017
• Study Start: June 27, 2017
• Primary Completion: November 25, 2019
• Study Completion: July 25, 2021
• Last Updated: August 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)