Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
255 participants
INTERVENTIONAL
2018-01-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The Danish National Clinical Guideline for the treatment of alcohol dependence recommends that alcohol treatment centers offer interventions aimed at CSOs, providing them with the support and empowerment that will enable them to motivate the problem drinker to enter treatment. In the US, the Community Reinforcement and Family Training (CRAFT) intervention has been shown to offer the most effective support to CSOs. CRAFT has consistently demonstrated a two to three times' higher impact on getting individual with an alcohol use disorder (AUD) to attend treatment, compared to other kinds of interventions. Studies of the intervention so far have, however, been small, and the format used in the delivery of CRAFT has not been fully investigated.
The aim of the present cluster randomized controlled trial is to implement and investigate CRAFT in a Danish context and with sufficient sample size. Consecutive CSOs will through cluster randomization be randomized to receive either CRAFT in a group format, CRAFT in an individual format, or a control condition, consisting of self-help material only. The primary outcome of the study will be the rate of individuals with AUD entering treatment following the intervention targeted at the CSOs within three months from its initiation. Data will be collected from all CSOs at baseline, three, and six months after baseline.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Group Version of CRAFT Compared to Self-Directed CRAFT Delivery and Non-intervention: a Three-armed RCT
NCT02510508
Exposure Therapy as Aftercare for Alcohol Use Disorder
NCT02298751
CRAFT Behavior Therapy: Treatment Entry Component
NCT00842036
Family Training Program for Parents of Substance Using Adolescents
NCT01344382
Treatment of Alcohol Problems in the Elderly
NCT02084173
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Individual CRAFT
Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions.
CRAFT
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
Group CRAFT
Open group CRAFT is offered to 135 participants in 6 sessions.
CRAFT
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
Self-help materials
Self-help materials (control group) are going to be offered a self-help book, because it is unethically not to offer any intervention, as the CRAFT intervention in early studies have shown to be very effectful
CRAFT
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CRAFT
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Being a CSO to a person with AUD who is not currently in treatment for alcohol problems
* Having the intention to maintain the contact during the next 90 days
* Having had regular contact with the problem drinker for the last 90 days (face-to-face contact for several hours on at least a weekly basis) and having the intention to maintain the contact during the next 90 days.
* Being prepared support the problem drinker if he/she chooses to seek treatment, at least to some extent.
Exclusion Criteria
* Not speaking Danish
* Being psychotic or otherwise severely mentally ill
* Suffering from AUD in the last three months
* Being concerned about a person who, according to the CSO, mainly use illegal substances
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kjeld Andersen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kjeld Andersen
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anette Søgaard Nielsen, Ass. Prof.
Role: STUDY_CHAIR
Unit of Clinical Research, University of Southern Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Unit if Clinical Alcohol Research
Odense, , Denmark
Research Unit of Psychiatry, Psychiatric Unit Odense - University function
Odense C, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hellum R, Bilberg R, Andersen K, Bischof G, Hesse M, Nielsen AS. Primary Outcome from a cluster-randomized trial of three formats for delivering Community Reinforcement and Family Training (CRAFT) to the significant others of problem drinkers. BMC Public Health. 2022 May 10;22(1):928. doi: 10.1186/s12889-022-13293-8.
Hellum R, Nielsen AS, Bischof G, Andersen K, Hesse M, Ekstrom CT, Bilberg R. Community reinforcement and family training (CRAFT) - design of a cluster randomized controlled trial comparing individual, group and self-help interventions. BMC Public Health. 2019 Mar 14;19(1):307. doi: 10.1186/s12889-019-6632-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRAFT112018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.