<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03281057</url>
  </required_header>
  <id_info>
    <org_study_id>CRAFT112018</org_study_id>
    <nct_id>NCT03281057</nct_id>
  </id_info>
  <brief_title>Community Reinforcement and Family Training (CRAFT)</brief_title>
  <acronym>CRAFT</acronym>
  <official_title>Community Reinforcement and Family Training (CRAFT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kjeld Andersen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study is dedicated to empowering individuals close to an addicted person (i.e.&#xD;
      concerned significant others, CSOs) to create changes in their family environment: changes&#xD;
      that increase the likelihood of the addicted person seeking treatment.&#xD;
&#xD;
      The Danish National Clinical Guideline for the treatment of alcohol dependence recommends&#xD;
      that alcohol treatment centers offer interventions aimed at CSOs, providing them with the&#xD;
      support and empowerment that will enable them to motivate the problem drinker to enter&#xD;
      treatment. In the US, the Community Reinforcement and Family Training (CRAFT) intervention&#xD;
      has been shown to offer the most effective support to CSOs. CRAFT has consistently&#xD;
      demonstrated a two to three times' higher impact on getting individual with an alcohol use&#xD;
      disorder (AUD) to attend treatment, compared to other kinds of interventions. Studies of the&#xD;
      intervention so far have, however, been small, and the format used in the delivery of CRAFT&#xD;
      has not been fully investigated.&#xD;
&#xD;
      The aim of the present cluster randomized controlled trial is to implement and investigate&#xD;
      CRAFT in a Danish context and with sufficient sample size. Consecutive CSOs will through&#xD;
      cluster randomization be randomized to receive either CRAFT in a group format, CRAFT in an&#xD;
      individual format, or a control condition, consisting of self-help material only. The primary&#xD;
      outcome of the study will be the rate of individuals with AUD entering treatment following&#xD;
      the intervention targeted at the CSOs within three months from its initiation. Data will be&#xD;
      collected from all CSOs at baseline, three, and six months after baseline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Cluster randomization Clinical trial with 3 arms - individual, group, and self-help intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whether the drinker has sought treatment for her/his alcohol use disorder</measure>
    <time_frame>3 months after baseline</time_frame>
    <description>The proportion of problem drinkers, who enter alcohol treatment centers from baseline and until three months after their CSOs enrolled in the CRAFT study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention</measure>
    <time_frame>3 and 6 months after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention</measure>
    <time_frame>3 and 6 months after baseline</time_frame>
    <description>Measured by the Relationship Happiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in number of sick leave days for concern significant others from 6 months before to 6 months after enrollment in the study.</measure>
    <time_frame>6 months after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life among concern significant others.</measure>
    <time_frame>3 and 6 months after baseline</time_frame>
    <description>Measured by WHO's quality of life scale &quot;WHOQol-Bref - Danish version&quot;</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">255</enrollment>
  <condition>CRAFT</condition>
  <condition>Concern Significant Others</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Individual CRAFT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group CRAFT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open group CRAFT is offered to 135 participants in 6 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-help materials</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CRAFT</intervention_name>
    <description>CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment</description>
    <arm_group_label>Group CRAFT</arm_group_label>
    <arm_group_label>Individual CRAFT</arm_group_label>
    <arm_group_label>Self-help materials</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Being a CSO to a person with AUD who is not currently in treatment for alcohol&#xD;
             problems&#xD;
&#xD;
          -  Having the intention to maintain the contact during the next 90 days&#xD;
&#xD;
          -  Having had regular contact with the problem drinker for the last 90 days (face-to-face&#xD;
             contact for several hours on at least a weekly basis) and having the intention to&#xD;
             maintain the contact during the next 90 days.&#xD;
&#xD;
          -  Being prepared support the problem drinker if he/she chooses to seek treatment, at&#xD;
             least to some extent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffering from dementia or other cognitive disorders&#xD;
&#xD;
          -  Not speaking Danish&#xD;
&#xD;
          -  Being psychotic or otherwise severely mentally ill&#xD;
&#xD;
          -  Suffering from AUD in the last three months&#xD;
&#xD;
          -  Being concerned about a person who, according to the CSO, mainly use illegal&#xD;
             substances&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anette Søgaard Nielsen, Ass. Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Unit of Clinical Research, University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Unit of Psychiatry, Psychiatric Unit Odense - University function</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unit if Clinical Alcohol Research</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://www.sdu.dk/en/om_sdu/institutter_centre/ucar</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Kjeld Andersen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03281057
org study id: CRAFT112018
nct id: NCT03281057
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study is dedicated to empowering individuals close to an addicted person (i.e.
      concerned significant others, CSOs) to create changes in their family environment: changes
      that increase the likelihood of the addicted person seeking treatment.

      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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomization Clinical trial with 3 arms - individual, group, and self-help intervention.
primary purpose: Treatment
masking: Single (Participant)
measure: Whether the drinker has sought treatment for her/his alcohol use disorder
time frame: 3 months after baseline
description: The proportion of problem drinkers, who enter alcohol treatment centers from baseline and until three months after their CSOs enrolled in the CRAFT study.
measure: Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention
time frame: 3 and 6 months after baseline
measure: Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention
time frame: 3 and 6 months after baseline
description: Measured by the Relationship Happiness Scale
measure: Changes in number of sick leave days for concern significant others from 6 months before to 6 months after enrollment in the study.
time frame: 6 months after baseline
measure: Changes in quality of life among concern significant others.
time frame: 3 and 6 months after baseline
description: Measured by WHO's quality of life scale "WHOQol-Bref - Danish version"
arm group label: Individual CRAFT
arm group type: Experimental
description: Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions.
arm group label: Group CRAFT
arm group type: Experimental
description: Open group CRAFT is offered to 135 participants in 6 sessions.
arm group label: Self-help materials
arm group type: Experimental
description: 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
intervention type: Behavioral
intervention name: CRAFT
description: CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
arm group label: Group CRAFT
arm group label: Individual CRAFT
arm group label: Self-help materials
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anette Søgaard Nielsen, Ass. Prof.
role: Study Chair
affiliation: Unit of Clinical Research, University of Southern Denmark
facility: 
facility: 
country: Denmark
url: http://www.sdu.dk/en/om_sdu/institutter_centre/ucar
description: Related Info
responsible party type: Sponsor-Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Kjeld Andersen
investigator title: Professor
mesh term: Alcoholism
sharing ipd: No