Study Stopped
Not enough participants were included
Group Version of CRAFT Compared to Self-Directed CRAFT Delivery and Non-intervention: a Three-armed RCT
A Group Version of Community Reinforcement and Family Training (CRAFT) Compared to Self-Directed CRAFT Delivery and Non-intervention: a Three-armed Randomized Clinical Trial
1 other identifier
interventional
29
1 country
6
Brief Summary
The aim of this study is to determine whether a group format Community Reinforcement and Family Training (CRAFT) and Self-Directed CRAFT Delivery are more effective than non-intervention in terms of Concerned Significant Others (CSO) well- being and cost- effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 21, 2017
August 1, 2017
1.2 years
July 16, 2015
August 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concerned Significant Other (CSO) well-being (physical and psychological)
Measured by the following tests:Measurement of the Addictions for Triage and Evaluation (MATE), Depression Anxiety Scales (DASS-21), Maudsley Addiction Profile (MAP), Research and Development- 36 (RAND- 36), Trimbos/iMTA questionnaire for Costs Associated with Psychiatric Illness (TicP) and EuroQol- 5D.
4 months after the initiation of the intervention
Secondary Outcomes (4)
CSO quality of life
4 months after the initiation of the intervention
CSO quality of the relationship
4 months after the initiation of the intervention
Other CSO reported psychological measures
4 months after the initiation of the intervention
Cost-effectiveness of group CRAFT and Self-Directed CRAFT Delivery compared to non-intervention condition
4 months after the initiation of the intervention
Other Outcomes (2)
Identified Patient (IP) engagement for all three conditions
4 months after the initiation of the intervention
CSO Drop-out
4 months after the initiation of the intervention
Study Arms (3)
Group CRAFT
EXPERIMENTALAll CSO's who are allocated to CRAFT group condition will be offered seven sessions of a CRAFT Group format. Each group will meet for 90 minutes weekly and will be completed within 2 months. The group content is based on the CRAFT techniques described by a training manual written by Roozen, Smith and Meyers (2015). Furthermore the CSOs in this condition will also receive a Dutch version of the CRAFT self-help book (Self Directed CRAFT Delivery), "Get your loved one sober: Alternatives to nagging, pleading and threatening" (Meyers \& Wolfe, 2012). Groups will engage in a combination of didactic teaching, role-play of new communication styles and discuss their experiences utilizing CRAFT skills.
Self-Directed CRAFT Delivery
ACTIVE COMPARATORCSO's allocated to the Self- Directed CRAFT Delivery will receive the Dutch version of the CRAFT self-help book, "Get your loved one sober: Alternatives to nagging, pleading and threatening" (Meyers \& Wolfe, 2012). The book helps CSO's how to utilize the CRAFT model in their daily lives. It includes guidelines for responding to IP behavior, improving positive communication skills, improving the CSO's own well-being and explains how to engage the IP into treatment.
Non-intervention
NO INTERVENTIONParticipants assigned to the non-intervention condition will be placed on a Group CRAFT waiting list.
Interventions
CSOs will receive seven weekly 90 min sessions of CRAFT + Self-Directed CRAFT Delivery
CRAFT self-help book (Self Directed CRAFT Delivery)
Non-intervention
Eligibility Criteria
You may qualify if:
- CSO has concern about and having direct knowledge of alcohol- and/or drug problems of an IP, who is either a first degree relative, intimate partner or close friend.
- Age at least 18 years (the CSO)
- Reports that IP is not currently in addiction treatment (at IrisZorg and elsewhere) and has not received addiction treatment in the past 3 months
- Reports that IP is treatment-refusing
- Evidence (according CSO) that the IP meets criteria for SUDs according to The Structured Clinical Interview for DSM IV axis 1 Disorders (SCID-I)
You may not qualify if:
- Does not demonstrate an adequate understanding of their participation, informed consent, and requirements of the protocol, or has insufficient reading abilities to comprehend the Dutch self-help book or does not agree to participate by refusing to sign an informed consent
- CSO meets the DSM-IV criteria for any current SUD diagnosis, through clinical assessment by The Structured Clinical Interview for DSM IV axis 1 Disorders (SCID-I) and the Dutch version of the Mini- International Neuropsychiatric Interview ( M.I.N.I.)
- Refuses to provide valid locator information, allow audiotaped sessions, and/or participate in follow-ups
- Evidence that the IP had received treatment (other than detoxification) for alcohol or drug problems in the prior three months, was mandated by the courts to receive treatment, or was currently motivated to accept treatment
- IP has a recent history of severe domestic violence
- CSO is involved in a concomitant intervention to get the IP in treatment or to improve their own well-being
- CSO fails to complete less than 4 Group CRAFT sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IrisZorglead
Study Sites (6)
IrisZorg
Arnhem, Gelderland, 6800, Netherlands
IrisZorg
Doetinchem, Gelderland, 7000, Netherlands
IrisZorg
Ede, Gelderland, 6710, Netherlands
IrisZorg
Nijmegen, Gelderland, 6500, Netherlands
IrisZorg
Tiel, Gelderland, 4000, Netherlands
IrisZorg
Zevenaar, Gelderland, 6900, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hendrik G Roozen, PhD
University of New Mexico; Department of Psychology/ CASAA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D
Study Record Dates
First Submitted
July 16, 2015
First Posted
July 29, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2016
Study Completion
February 1, 2017
Last Updated
August 21, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share