<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/NCT04400526</url>
  </required_header>
  <id_info>
    <org_study_id>BDF 190003</org_study_id>
    <nct_id>NCT04400526</nct_id>
  </id_info>
  <brief_title>Development of a Community-based Network for Drug Abusers</brief_title>
  <official_title>Development of a Community-based Network to Identify and Refer Drug Abusers in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</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>
      Hidden drug abuse remains a significant concern for public health. An appropriate&#xD;
      intervention is necessary to encourage hidden drug abusers to report their situations and&#xD;
      seek professional help. This project aims to develop a community-based network to identify&#xD;
      and refer hidden drug abusers in Hong Kong, and assess its effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be completed within 18 months, and be divided into 3 Phases, including (1) a&#xD;
      video competition for anti-drug abuse, (2) development of a community-based network through&#xD;
      training 150 peers aged 13-18 as anti-drug ambassadors (ADAs) to deliver anti-drug messages&#xD;
      based on the AWARD model, and (3) a mass promotional campaign organized by ADAs in the&#xD;
      community. A one-group pre-test and repeated post-test design will be adopted to evaluate the&#xD;
      overall effectiveness of the community-based network. We will assess the knowledge, attitudes&#xD;
      and practices regarding anti-drug abuse of the ADAs. Data collection will be conducted at&#xD;
      baseline, post-training, 3 months and 6 months after the training workshop.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge about the hazardous effects of drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 2</measure>
    <time_frame>Immediately after the training workshop</time_frame>
    <description>Change in knowledge about the hazardous effects of drug abuse among ADAs immediately after the training workshop when compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge about the hazardous effects of drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 2</measure>
    <time_frame>3 months after the training workshop</time_frame>
    <description>Change in knowledge about the hazardous effects of drug abuse among ADAs at 3 months after the training workshop when compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge about the hazardous effects of drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 2</measure>
    <time_frame>6 months after the training workshop</time_frame>
    <description>Change in knowledge about the hazardous effects of drug abuse among ADAs at 6 months after the training workshop when compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attitudes towards drug abuse and anti-drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 1</measure>
    <time_frame>Immediately after the training workshop</time_frame>
    <description>Change in attitudes towards drug abuse and anti-drug abuse among ADAs immediately after the training workshop when compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attitudes towards drug abuse and anti-drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 1</measure>
    <time_frame>3 months after the training workshop</time_frame>
    <description>Change in attitudes towards drug abuse and anti-drug abuse among ADAs at 3 months after the training workshop when compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attitudes towards drug abuse and anti-drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 1</measure>
    <time_frame>6 months after the training workshop</time_frame>
    <description>Change in attitudes towards drug abuse and anti-drug abuse among ADAs at 6 months after the training workshop when compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anti-drug practices among ADAs by using Anti-Drug Practice Questionnaires</measure>
    <time_frame>3 months after the training workshop</time_frame>
    <description>Personal development questions among ADAs at 3 months after the training workshop when compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anti-drug practices among ADAs by using Anti-Drug Practice Questionnaires</measure>
    <time_frame>6 months after the training workshop</time_frame>
    <description>Personal development questions among ADAs at 6 months after the training workshop when compared to baseline</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Adolescent</condition>
  <arm_group>
    <arm_group_label>Phase 1: A video competition for anti-drug abuse</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phase 1 aims to increase the public awareness of hazardous effects of drug abuses and existing resources available for drug abusers through a video competition. We will co-organize a video competition for anti-drug abuse with C.H.O.I.C.E. The competition will appeal to the participation of all children (aged 13-18) living in the four targeted districts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: Developing a community-based network</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phase 2 aims to develop a community-based network through training anti-drug ambassadors (ADAs). We target to recruit a total of 150 children aged 13 - 18 as ADAs through secondary schools and community centres in the four targeted districts by sending invitation letters. The content of the workshop will be designed by our expert panel. The content of the workshop will include (1) hazardous effects of drug abuse especially less psychotropic drugs such as Cannabis, (2) signs and symptoms of drug abuse particularly less psychotropic drugs like Cannabis, (3) alternatives to drug abuse, (4) community resources available, and (5) how to refer drug abusers. Besides, all children will be taught to use the AWARD model for referrals in the workshop.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: A mass promotional campaign</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phase 3 aims to engage the public to join the community-based network through anti-drug activities organized by anti-drug ambassadors. They are encouraged to design their own promotional activities for community members in the targeted districts.Types of activities can include but not limited to health talks, booths, outreaching activities, games, posters, leaflets and websites.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A video competition</intervention_name>
    <description>Each Individual/group will be required to produce a maximum of 2-minute video on one of the following themes: (1) the hazardous effects of drug especially less psychotropic drugs such as Cannabis, (2) encouraging messages to drug abusers, and (3) existing anti-drug services.</description>
    <arm_group_label>Phase 1: A video competition for anti-drug abuse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A training workshop</intervention_name>
    <description>The workshop will last for 6 hours, and will be delivered by an experienced counsellor from C.H.O.I.C.E. The content of the workshop will include (1) hazardous effects of drug abuse especially less psychotropic drugs such as Cannabis, (2) signs and symptoms of drug abuse particularly less psychotropic drugs like Cannabis, (3) alternatives to drug abuse, (4) community resources available, and (5) how to refer drug abusers. Besides, all children will be taught to use the AWARD model for referrals in the workshop.</description>
    <arm_group_label>Phase 2: Developing a community-based network</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A mass promotional campaign</intervention_name>
    <description>Children who complete the training workshop in phase 2 will be invited to join phase 3. They are encouraged to design their own promotional activities for community members in the targeted districts. The activities can be delivered by a group (a maximum of 5 ADAs per group) or by an individual. Types of activities can include but not limited to health talks, booths, outreaching activities, games, posters, leaflets and websites. Likewise, if the ADAs encounter any drug abuser in their social circles, the ADAs will be asked to deliver a brief advice based on the AWARD model.</description>
    <arm_group_label>Phase 3: A mass promotional campaign</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 13 - 18 years&#xD;
&#xD;
          -  Able to speak Cantonese and read Chinese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  identified cognitive, behavioral or learning problem(s)&#xD;
&#xD;
          -  identified mental illness(es)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ka Yan Ho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ka Yan Ho, PhD</last_name>
    <phone>27666417</phone>
    <email>kyeva.ho@polyu.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ka Yan Ho, PhD</last_name>
    <phone>27666417</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ka Yan HO</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong, China</state>
        <zip>0000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <contact>
      <last_name>Ka Yan HO, PhD</last_name>
      <phone>852 27666417</phone>
      <email>kyeva.ho@polyu.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 20, 2021</last_update_submitted>
  <last_update_submitted_qc>May 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hidden drug abuse</keyword>
  <keyword>Community-based network</keyword>
  <keyword>Ambassadors</keyword>
  <keyword>Brief intervention</keyword>
  <keyword>Adolescents</keyword>
  <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/NCT04400526
org study id: BDF 190003
nct id: NCT04400526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hidden drug abuse remains a significant concern for public health. An appropriate
      intervention is necessary to encourage hidden drug abusers to report their situations and
      seek professional help. This project aims to develop a community-based network to identify
      and refer hidden drug abusers in Hong Kong, and assess its effectiveness.
This study will be completed within 18 months, and be divided into 3 Phases, including (1) a
      video competition for anti-drug abuse, (2) development of a community-based network through
      training 150 peers aged 13-18 as anti-drug ambassadors (ADAs) to deliver anti-drug messages
      based on the AWARD model, and (3) a mass promotional campaign organized by ADAs in the
      community. A one-group pre-test and repeated post-test design will be adopted to evaluate the
      overall effectiveness of the community-based network. We will assess the knowledge, attitudes
      and practices regarding anti-drug abuse of the ADAs. Data collection will be conducted at
      baseline, post-training, 3 months and 6 months after the training workshop.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in knowledge about the hazardous effects of drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 2
time frame: Immediately after the training workshop
description: Change in knowledge about the hazardous effects of drug abuse among ADAs immediately after the training workshop when compared to baseline
measure: Change in knowledge about the hazardous effects of drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 2
time frame: 3 months after the training workshop
description: Change in knowledge about the hazardous effects of drug abuse among ADAs at 3 months after the training workshop when compared to baseline
measure: Change in knowledge about the hazardous effects of drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 2
time frame: 6 months after the training workshop
description: Change in knowledge about the hazardous effects of drug abuse among ADAs at 6 months after the training workshop when compared to baseline
measure: Change in attitudes towards drug abuse and anti-drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 1
time frame: Immediately after the training workshop
description: Change in attitudes towards drug abuse and anti-drug abuse among ADAs immediately after the training workshop when compared to baseline
measure: Change in attitudes towards drug abuse and anti-drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 1
time frame: 3 months after the training workshop
description: Change in attitudes towards drug abuse and anti-drug abuse among ADAs at 3 months after the training workshop when compared to baseline
measure: Change in attitudes towards drug abuse and anti-drug abuse among ADAs by using Beat Drugs Fund Evaluation Question Set No. 1
time frame: 6 months after the training workshop
description: Change in attitudes towards drug abuse and anti-drug abuse among ADAs at 6 months after the training workshop when compared to baseline
measure: Change in anti-drug practices among ADAs by using Anti-Drug Practice Questionnaires
time frame: 3 months after the training workshop
description: Personal development questions among ADAs at 3 months after the training workshop when compared to baseline
measure: Change in anti-drug practices among ADAs by using Anti-Drug Practice Questionnaires
time frame: 6 months after the training workshop
description: Personal development questions among ADAs at 6 months after the training workshop when compared to baseline
arm group label: Phase 1: A video competition for anti-drug abuse
arm group type: Other
description: Phase 1 aims to increase the public awareness of hazardous effects of drug abuses and existing resources available for drug abusers through a video competition. We will co-organize a video competition for anti-drug abuse with C.H.O.I.C.E. The competition will appeal to the participation of all children (aged 13-18) living in the four targeted districts.
arm group label: Phase 2: Developing a community-based network
arm group type: Other
description: Phase 2 aims to develop a community-based network through training anti-drug ambassadors (ADAs). We target to recruit a total of 150 children aged 13 - 18 as ADAs through secondary schools and community centres in the four targeted districts by sending invitation letters. The content of the workshop will be designed by our expert panel. The content of the workshop will include (1) hazardous effects of drug abuse especially less psychotropic drugs such as Cannabis, (2) signs and symptoms of drug abuse particularly less psychotropic drugs like Cannabis, (3) alternatives to drug abuse, (4) community resources available, and (5) how to refer drug abusers. Besides, all children will be taught to use the AWARD model for referrals in the workshop.
arm group label: Phase 3: A mass promotional campaign
arm group type: Other
description: Phase 3 aims to engage the public to join the community-based network through anti-drug activities organized by anti-drug ambassadors. They are encouraged to design their own promotional activities for community members in the targeted districts.Types of activities can include but not limited to health talks, booths, outreaching activities, games, posters, leaflets and websites.
intervention type: Behavioral
intervention name: A video competition
description: Each Individual/group will be required to produce a maximum of 2-minute video on one of the following themes: (1) the hazardous effects of drug especially less psychotropic drugs such as Cannabis, (2) encouraging messages to drug abusers, and (3) existing anti-drug services.
arm group label: Phase 1: A video competition for anti-drug abuse
intervention type: Behavioral
intervention name: A training workshop
description: The workshop will last for 6 hours, and will be delivered by an experienced counsellor from C.H.O.I.C.E. The content of the workshop will include (1) hazardous effects of drug abuse especially less psychotropic drugs such as Cannabis, (2) signs and symptoms of drug abuse particularly less psychotropic drugs like Cannabis, (3) alternatives to drug abuse, (4) community resources available, and (5) how to refer drug abusers. Besides, all children will be taught to use the AWARD model for referrals in the workshop.
arm group label: Phase 2: Developing a community-based network
intervention type: Behavioral
intervention name: A mass promotional campaign
description: Children who complete the training workshop in phase 2 will be invited to join phase 3. They are encouraged to design their own promotional activities for community members in the targeted districts. The activities can be delivered by a group (a maximum of 5 ADAs per group) or by an individual. Types of activities can include but not limited to health talks, booths, outreaching activities, games, posters, leaflets and websites. Likewise, if the ADAs encounter any drug abuser in their social circles, the ADAs will be asked to deliver a brief advice based on the AWARD model.
arm group label: Phase 3: A mass promotional campaign
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ka Yan Ho, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
last name: Ka Yan Ho, PhD
phone: 27666417
email: kyeva.ho@polyu.edu.hk
last name: Ka Yan Ho, PhD
phone: 27666417
facility: 
contact: 
country: Hong Kong
responsible party type: Sponsor
sharing ipd: No