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

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ClinicalTrials.gov Identifier: NCT03203889
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of New Mexico

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 Signficant 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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Family Members Behavioral: CRAFT-AI Behavioral: TSF-CSO Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of CRAFT With American Indians
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: CRAFT-AI
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
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
Other Name: CRAFT

Active Comparator: 12-step facilitation for loved ones
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
In individual sessions, the counselor facilitates the CSO's affiliation and involvement in Nar-Anon or Al-Anon groups to work the steps.
Other Names:
  • Nar-Anonymous Facilitation
  • Al-Anonymous Facilitation
  • Twelve-step Facilitation for Concerned Significant Others




Primary Outcome Measures :
  1. Identified person with addiction's treatment entry or seeking traditional healing [ Time Frame: 6 months post CSO baseline ]
    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


Secondary Outcome Measures :
  1. Relationship functioning [ Time Frame: 6 months post CSO baseline ]
    dyadic adjustment scale score

  2. Concerned significant other functioning [ Time Frame: 6 months post CSO baseline ]
    Beck Depression Inventory II

  3. Concerned Significant Other functioning II [ Time Frame: 6 months post CSO baseline ]
    State Trait Anxiety Inventory

  4. Concerned Significant Other functioning III [ Time Frame: 6 months post CSO baseline ]
    State Trait Anger Expression Inventory

  5. Concerned Significant Other functioning IV [ Time Frame: 6 months post CSO baseline ]
    SF-36

  6. Relationship Functioning II [ Time Frame: 6 months post CSO baseline ]
    Family Environment Scale

  7. Relationship Functioning III [ Time Frame: 6 month post CSO baseline ]
    IP Conflict Tactics Scale


Other Outcome Measures:
  1. effect sizes [ Time Frame: 6 months post CSO baseline ]
    effect size between intervention arms primary outcomes and secondary outcomes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. are at least 18 years of age;
  2. are a member of this AI tribe and living within 60 mile radius of the research or treatment site (i.e., the reservation);
  3. 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);
  4. are concerned about an AI with an SUD (IP) who is an intimate partner, relative (sanguine or not), or close friend;
  5. 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;
  6. describe the IP behavior as consistent with Diagnostic and Statistical Manual of Mental Disorders SUD criteria 5th edition, DSM-5;
  7. are willing to participate in the research; and
  8. 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:

  1. meets criteria for injectable drug SUD (but other SUD allowable)
  2. 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;
  3. intends to seek more than 6 hours of additional behavioral health treatment (not including substance abuse treatment) in the next 3 months;
  4. has an IP who has received a Johnson Institute Intervention within the prior 3 years; or
  5. reports severe domestic violence (including use of a weapon or injury requiring hospitalization) at the hand of the IP.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203889


Contacts
Contact: Kamilla Venner, PhD (505)277-1783 kamilla@unm.edu
Contact: Deanna Sprunk (505)925-2330 ctn@unm.edu

Locations
United States, New Mexico
Zuni Recovery Center Recruiting
Zuni, New Mexico, United States, 87327
Contact: Marnella Kucate-Yepa    505-782-7022    Marnella.Kucate-Yepa@ashiwi.org   
Contact: Emma Muhammed    5057824717    Emma.Muhammad@ashiwi.org   
Sponsors and Collaborators
University of New Mexico
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kamilla Venner, PhD University of New Mexico

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT03203889     History of Changes
Other Study ID Numbers: 947549-2
R34DA040064-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing of these data will have to be negotiated with tribal partner.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of New Mexico:
American Indians
Native Americans
Community Reinforcement Approach and Family Training
Nar-Anonymous Facilitation
Treatment Entry
Cultural adaptations
Spirituality

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders