<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/NCT04461314</url>
  </required_header>
  <id_info>
    <org_study_id>MedPAC Hotline</org_study_id>
    <nct_id>NCT04461314</nct_id>
  </id_info>
  <brief_title>Hotline Service for Drug-abusing Youth and Young Adults</brief_title>
  <official_title>MedPAC Hotline: A Medical Peer Addiction Counselling Hotline Service for Drug-abusing Youth and Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      Aim: Providing peer counselling service delivered by student counsellors with a medical&#xD;
      background via a hotline to drug-abusing youth and young adult aged 35 or below.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      i. To raise anti-drug awareness of young people in general and identify high-risk/hidden&#xD;
      drug-abusing youth and young adult aged 35 or below in Hong Kong; and ii. To train university&#xD;
      students with a medical background as peer counsellors; and iii. To provide drug abuse&#xD;
      hotline service by students with a medical background as peer counsellors to drug-abusing&#xD;
      youth and young adult aged 35 or below, and other people who call for help, including drug&#xD;
      abusers' family members, friends, and professionals; and iv. To improve the drug-abusing&#xD;
      youth and young adult' knowledge about the hazard of drug abuse, negative attitude, and&#xD;
      perception towards the drug abuse through the telephone peer counselling service provided by&#xD;
      students with medical background; and v. To increase the intention to quit and the&#xD;
      help-seeking behavior among the drug-abusing youth and young adult; vi. To increase reduction&#xD;
      rate and abstinence rate from drug abuse, and decrease the relapse rate among drug-abusing&#xD;
      youth and young adult through the telephone peer counseling service.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MedPAC Hotline Service will be promoted to high-risk and drug-abusing youth and young&#xD;
      adults through a variety of platforms, namely schools and youth service organizations,&#xD;
      industries, community, mass media and internet, social media, posters and snowball approach.&#xD;
&#xD;
      The hotline service will operate from 5 p.m. to 9 p.m. on weekday and from 2 p.m. to 8 p.m.&#xD;
      on weekend. A peer counsellor or a research assistant will answer the telephone inquiries&#xD;
      from 9:30 a.m. to 5 p.m. on weekdays.&#xD;
&#xD;
      About 50 university students will be trained as peer counsellors through a structured&#xD;
      training programme. The students will be invited to complete the pre, post and 6-month&#xD;
      self-administered questionnaire before, immediately and 6-month after the training programme&#xD;
      to examine their changes of knowledge of and attitudes towards addiction counselling. A&#xD;
      satisfaction survey will also be conducted to measure their perception on the quality of&#xD;
      training programme.&#xD;
&#xD;
      Peer counsellors will use telephone-based, Peer-led Brief Motivational Interviewing (BMI)&#xD;
      counselling to motivate and encourage drug-abusing or high-risk youth and young adults to&#xD;
      rehabilitate from drug abuse, assist them to manage the withdrawal symptoms, and help&#xD;
      identify barriers and facilitators to rehabilitate from drug abuse in the telephone&#xD;
      counselling. The peer counsellors will give referral advices if the youth and young adult&#xD;
      needs appropriated treatment and rehabilitation services.&#xD;
&#xD;
      The drug-abusing youth and young adults will be counselled and invited to complete the&#xD;
      follow-up questionnaires over the telephone after joining the MedPAC Hotline Service&#xD;
      programme for 1 week, 1 month, 3 months, 6 months, 9 months and 1 year. Self-reported&#xD;
      quitters at 6-month and 1-year follow-ups were invited to have urine test to validate the&#xD;
      drug abuse abstinence status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</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 drug consumption at 12-month follow-up</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Drug abuser's drug consumption is measured at 12-month follow-up. A questionnaire asking the frequency of drug use in the past 30 days will be used for assessing the self-reported change in drug consumption.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30 days self-reported drug abstinence at 6-month and 12-month follow-up</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Self-reported drug abstinence (do not use drug for at least 30 days during the time of follow-up) at 6-month and 12-month. A questionnaire asking the drug use status, quitting experience will be used for assessing the self-reported drug abstinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in drug consumption at 6-month follow-up</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Drug abuser's drug consumption is measured at 6-month follow-up. A questionnaire asking the frequency of drug use in the past 30 days will br used for assessing the self-reported change in drug consumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in relapse risk among the quitters</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Drug quitter's relapse risk is measured at 12-month follow-up. A questionnaire using Stimulant Relapse Risk Scale (SRRS) with the questions of the intention to use drugs, compulsivity for drugs and impetus and confidence to avoid drugs etc. will be used for assessing the relapse risk at 12-month follow-up. The higher the scores, the higher the relapse risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the contemplation stage</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Drug abuser's change of the contemplation stage at 6-month and 12-month follow-up. A questionnaire asking the intention to quit drug abuse and experience of drug abstinence to match the stage in contemplation ladder will be used for assessing the contemplation stage at 6-month and 12-month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of the perceived treatment needs and motivation towards solving the problem of drug abuse</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Drug abuser's change of perceived treatment needs and motivation towards solving the problem among drug abusers at 6-month and 12-month. A questionnaire using the Treatment Needs/Motivation Scales (TCU MOTForm) will be used for assessing the level of the intention and motivation to receive treatment of solving the drug abuse problem. The higher the scores, the higher the perceived treatment needs and motivation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of self-efficacy of drug abusers to avoid drug use</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Drug abuser's change of self-efficacy to avoid drug use at 6-month and 12-month follow-up. The Adolescent Relapse Coping Questionnaire (ARCQ) will be used for evaluating the self-efficacy to avoid drug use. It comprises 6 questions for a given condition about drug temptation. The higher the score, the higher the self-efficacy of drug abusers to avoid drug use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug abuser's improvement of knowledge and attitude on drug abuse hazards</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Drug abuser's improvement of knowledge and attitude on drug abuse hazards at 6-month and 12-month follow-up. A questionnaire asking about the knowledge and attitude on drug abuse with a scale called &quot;knowledge and attitude on drug abuse for drug abuser&quot; will be used for assessing the change of knowledge and attitude on drug abuse. The higher the scores, the better the knowledge and attitude.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peer counsellor's improvement of knowledge and attitude on drug abuse hazards</measure>
    <time_frame>Baseline, immediately after the training programme and 6 months</time_frame>
    <description>Peer counsellor's improvement of knowledge and attitude on drug abuse hazards immediately after the training programme and after 6 months will be measured by a scale called &quot;knowledge and attitude on drug abuse for peer counsellor&quot; in a self-reporting structured questionnaire. The higher the scores, the better the knowledge and attitude.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of peer counsellors to the drug abuse training programme</measure>
    <time_frame>Immediately after the training programme</time_frame>
    <description>Satisfaction of peer counsellors to the drug abuse training programme will be collected. A questionnaire asking about the comments of content, practicability, speakers from the peer counsellors with the satisfaction scale will be used for evaluating the satisfaction immediately after the training programme. The higher the scores, the greater the satisfaction of the training programme.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Drug Abuse</condition>
  <arm_group>
    <arm_group_label>Peer-led counselling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>About 50 university students trained as peer telephone counsellors through a structured training programme.&#xD;
About 200 Drug-abusing youth and young adults received telephone-based, Peer-led Brief Motivational Interviewing (BMI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>peer-led counselling</intervention_name>
    <description>About 50 university students will be trained as peer counsellors through a structured training programme. A pre and post and 6-month self-administered questionnaire will be conducted before, immediately and 6-month after the training programme to examine their changes of knowledge and attitudes. A satisfaction survey will also be conducted to measure participants' perception of the quality of the training programme.&#xD;
Drug-abusing youth and young adults will receive telephone-based, Peer-led Brief Motivational Interviewing (BMI) counselling to rehabilitate from drug abuse. The peer counsellors will give referral advice if the youth and young adult needs appropriate treatment and rehabilitation services.&#xD;
The drug abusers will be counselled and invited to complete the follow-up questionnaires at 1 week, 1 month, 3 months, 6 months, 9 months and 1 year. Self-reported quitters at 6-month and 1-year follow-ups will be invited to have a urine test to validate the drug abuse abstinence.</description>
    <arm_group_label>Peer-led counselling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion criteria of target service group for this quitline programme is that&#xD;
             current drug abusers in Hong Kong who should (1) be aged 35 or below, (2) be able to&#xD;
             communicate in Cantonese, and (3) have a history of drug abuse within the past 12&#xD;
             months (including all types of drugs such as narcotics analgesics, hallucinogens,&#xD;
             depressants, stimulants, tranquillizers and other recreational drugs).&#xD;
&#xD;
          -  The inclusion criteria of peer counsellors providing counselling service in this&#xD;
             quitline programme are those who should (1) be aged 18 - 35, (2) be able to&#xD;
             communicate in Cantonese, (3) have a medical background, (4) complete the training&#xD;
             courses and pass the evaluation of peer counsellor qualification.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who are psychologically or physically unable to communicate will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ho Cheung William Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ho Cheung William Li, PhD</last_name>
    <phone>+85239176634</phone>
    <email>william3@hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei Xia, PhD</last_name>
    <phone>+85239176650</phone>
    <email>xiavive@hku.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Pokfulam</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ho Cheung William Li, PhD</last_name>
      <phone>+85239176634</phone>
      <email>william3@hku.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. LI William Ho Cheung</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Youth</keyword>
  <keyword>Hotline</keyword>
  <keyword>Drug abuse</keyword>
  <keyword>Young Adult</keyword>
  <keyword>Addiction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The relevant anonymized patient-level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.</ipd_description>
    <ipd_time_frame>After the project is completed and the results of the project have been published.</ipd_time_frame>
    <ipd_access_criteria>Request could be sent to Principal Investigator (william3@hku.hk)</ipd_access_criteria>
  </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/NCT04461314
org study id: MedPAC Hotline
nct id: NCT04461314
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: Providing peer counselling service delivered by student counsellors with a medical
      background via a hotline to drug-abusing youth and young adult aged 35 or below.

      Objectives:

      i. To raise anti-drug awareness of young people in general and identify high-risk/hidden
      drug-abusing youth and young adult aged 35 or below in Hong Kong; and ii. To train university
      students with a medical background as peer counsellors; and iii. To provide drug abuse
      hotline service by students with a medical background as peer counsellors to drug-abusing
      youth and young adult aged 35 or below, and other people who call for help, including drug
      abusers' family members, friends, and professionals; and iv. To improve the drug-abusing
      youth and young adult' knowledge about the hazard of drug abuse, negative attitude, and
      perception towards the drug abuse through the telephone peer counselling service provided by
      students with medical background; and v. To increase the intention to quit and the
      help-seeking behavior among the drug-abusing youth and young adult; vi. To increase reduction
      rate and abstinence rate from drug abuse, and decrease the relapse rate among drug-abusing
      youth and young adult through the telephone peer counseling service.
The MedPAC Hotline Service will be promoted to high-risk and drug-abusing youth and young
      adults through a variety of platforms, namely schools and youth service organizations,
      industries, community, mass media and internet, social media, posters and snowball approach.

      The hotline service will operate from 5 p.m. to 9 p.m. on weekday and from 2 p.m. to 8 p.m.
      on weekend. A peer counsellor or a research assistant will answer the telephone inquiries
      from 9:30 a.m. to 5 p.m. on weekdays.

      About 50 university students will be trained as peer counsellors through a structured
      training programme. The students will be invited to complete the pre, post and 6-month
      self-administered questionnaire before, immediately and 6-month after the training programme
      to examine their changes of knowledge of and attitudes towards addiction counselling. A
      satisfaction survey will also be conducted to measure their perception on the quality of
      training programme.

      Peer counsellors will use telephone-based, Peer-led Brief Motivational Interviewing (BMI)
      counselling to motivate and encourage drug-abusing or high-risk youth and young adults to
      rehabilitate from drug abuse, assist them to manage the withdrawal symptoms, and help
      identify barriers and facilitators to rehabilitate from drug abuse in the telephone
      counselling. The peer counsellors will give referral advices if the youth and young adult
      needs appropriated treatment and rehabilitation services.

      The drug-abusing youth and young adults will be counselled and invited to complete the
      follow-up questionnaires over the telephone after joining the MedPAC Hotline Service
      programme for 1 week, 1 month, 3 months, 6 months, 9 months and 1 year. Self-reported
      quitters at 6-month and 1-year follow-ups were invited to have urine test to validate the
      drug abuse abstinence status.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in drug consumption at 12-month follow-up
time frame: Baseline and 12 months
description: Drug abuser's drug consumption is measured at 12-month follow-up. A questionnaire asking the frequency of drug use in the past 30 days will be used for assessing the self-reported change in drug consumption.
measure: 30 days self-reported drug abstinence at 6-month and 12-month follow-up
time frame: Baseline, 6 months and 12 months
description: Self-reported drug abstinence (do not use drug for at least 30 days during the time of follow-up) at 6-month and 12-month. A questionnaire asking the drug use status, quitting experience will be used for assessing the self-reported drug abstinence.
measure: Change in drug consumption at 6-month follow-up
time frame: Baseline and 6 months
description: Drug abuser's drug consumption is measured at 6-month follow-up. A questionnaire asking the frequency of drug use in the past 30 days will br used for assessing the self-reported change in drug consumption.
measure: Change in relapse risk among the quitters
time frame: Baseline and 12 months
description: Drug quitter's relapse risk is measured at 12-month follow-up. A questionnaire using Stimulant Relapse Risk Scale (SRRS) with the questions of the intention to use drugs, compulsivity for drugs and impetus and confidence to avoid drugs etc. will be used for assessing the relapse risk at 12-month follow-up. The higher the scores, the higher the relapse risk.
measure: Change of the contemplation stage
time frame: Baseline, 6 months and 12 months
description: Drug abuser's change of the contemplation stage at 6-month and 12-month follow-up. A questionnaire asking the intention to quit drug abuse and experience of drug abstinence to match the stage in contemplation ladder will be used for assessing the contemplation stage at 6-month and 12-month.
measure: Changes of the perceived treatment needs and motivation towards solving the problem of drug abuse
time frame: Baseline, 6 months and 12 months
description: Drug abuser's change of perceived treatment needs and motivation towards solving the problem among drug abusers at 6-month and 12-month. A questionnaire using the Treatment Needs/Motivation Scales (TCU MOTForm) will be used for assessing the level of the intention and motivation to receive treatment of solving the drug abuse problem. The higher the scores, the higher the perceived treatment needs and motivation.
measure: Change of self-efficacy of drug abusers to avoid drug use
time frame: Baseline, 6 months and 12 months
description: Drug abuser's change of self-efficacy to avoid drug use at 6-month and 12-month follow-up. The Adolescent Relapse Coping Questionnaire (ARCQ) will be used for evaluating the self-efficacy to avoid drug use. It comprises 6 questions for a given condition about drug temptation. The higher the score, the higher the self-efficacy of drug abusers to avoid drug use.
measure: Drug abuser's improvement of knowledge and attitude on drug abuse hazards
time frame: Baseline, 6 months and 12 months
description: Drug abuser's improvement of knowledge and attitude on drug abuse hazards at 6-month and 12-month follow-up. A questionnaire asking about the knowledge and attitude on drug abuse with a scale called "knowledge and attitude on drug abuse for drug abuser" will be used for assessing the change of knowledge and attitude on drug abuse. The higher the scores, the better the knowledge and attitude.
measure: Peer counsellor's improvement of knowledge and attitude on drug abuse hazards
time frame: Baseline, immediately after the training programme and 6 months
description: Peer counsellor's improvement of knowledge and attitude on drug abuse hazards immediately after the training programme and after 6 months will be measured by a scale called "knowledge and attitude on drug abuse for peer counsellor" in a self-reporting structured questionnaire. The higher the scores, the better the knowledge and attitude.
measure: Satisfaction of peer counsellors to the drug abuse training programme
time frame: Immediately after the training programme
description: Satisfaction of peer counsellors to the drug abuse training programme will be collected. A questionnaire asking about the comments of content, practicability, speakers from the peer counsellors with the satisfaction scale will be used for evaluating the satisfaction immediately after the training programme. The higher the scores, the greater the satisfaction of the training programme.
arm group label: Peer-led counselling
arm group type: Other
description: About 50 university students trained as peer telephone counsellors through a structured training programme.
About 200 Drug-abusing youth and young adults received telephone-based, Peer-led Brief Motivational Interviewing (BMI)
intervention type: Behavioral
intervention name: peer-led counselling
description: About 50 university students will be trained as peer counsellors through a structured training programme. A pre and post and 6-month self-administered questionnaire will be conducted before, immediately and 6-month after the training programme to examine their changes of knowledge and attitudes. A satisfaction survey will also be conducted to measure participants' perception of the quality of the training programme.
Drug-abusing youth and young adults will receive telephone-based, Peer-led Brief Motivational Interviewing (BMI) counselling to rehabilitate from drug abuse. The peer counsellors will give referral advice if the youth and young adult needs appropriate treatment and rehabilitation services.
The drug abusers will be counselled and invited to complete the follow-up questionnaires at 1 week, 1 month, 3 months, 6 months, 9 months and 1 year. Self-reported quitters at 6-month and 1-year follow-ups will be invited to have a urine test to validate the drug abuse abstinence.
arm group label: Peer-led counselling
criteria: 
gender: All
minimum age: N/A
maximum age: 35 Years
healthy volunteers: No
last name: Ho Cheung William Li, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Ho Cheung William Li, PhD
phone: +85239176634
email: william3@hku.hk
last name: Wei Xia, PhD
phone: +85239176650
email: xiavive@hku.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. LI William Ho Cheung
investigator title: Associate Professor
mesh term: Substance-Related Disorders
sharing ipd: Yes
ipd description: The relevant anonymized patient-level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
ipd time frame: After the project is completed and the results of the project have been published.
ipd access criteria: Request could be sent to Principal Investigator (william3@hku.hk)