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Health-risk BehavioursNCT05918601

Peer-led Personalized Support Program

A study testing Health-risk behaviors, Theory of planned behavior, Self-determination theory and Assist them to adhere to their schedule of quitting drugs throughout the study period in people with Health-risk Behaviours and Drug Abuse, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Aim: To test the effectiveness of a peer-led personalized support program using instant messaging applications and a self- determination theory-based intervention to help young drug abusers quit drugs. Read more about this study

Who is it for?
Any age
Conditions the study is for
Health-risk Behaviours, Drug Abuse
What is being tested?
Health-risk behaviors, Theory of planned behavior, Self-determination theory and Assist them to adhere to their schedule of quitting drugs throughout the study period
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteHong Kong
Study dates
30 Jun 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

The inclusion criteria of target service group (drug abusers) for this programme:

  • be aged 35 or below
  • be able to communicate in Cantonese
  • have an history of drug abuse within the past 12 months (including all types of drugs such as narcotics analgesics, hallucinogens, depressants, stimulants, tranquillizers and other recreational drugs)

The exclusion Criteria of target service group (drug abusers) for this programme:

  • psychologically or physically unable to communicate

The inclusion criteria of peer supporters:

  • be aged 18 - 35
  • be able to communicate in Cantonese
  • have a medical background
  • complete the training courses and pass the evaluation of peer supporter qualification

The exclusion Criteria of peer supporters:

  • psychologically or physically unable to communicate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ho Cheung William Li contact

39430889

williamli@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • The Chinese University of Hong Kong

    Hong Kong

    Ho Cheung William Li, Phd, 39430889, williamli@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effectiveness of a Peer-led Personalized Support Program Using Instant Messaging Applications and a Self-determination Theory-based Intervention to Help Young Drug Abusers Quit Drugs: A Randomized Controlled Trial

Aim: To test the effectiveness of a peer-led personalized support program using instant messaging applications and a self- determination theory-based intervention to help young drug abusers quit drugs.

Hypothesis to be tested: The investigators hypothesize that compared with those in the control group, the participants in the intervention group will experience greater success in reducing and quitting drugs and will have a better health-related quality of life at 12 months follow-up.

Read the detailed description

Setting:

A pre- and post-test interventional study will be conducted in the peer supporters. A randomized controlled trial (RCT) will be carried out attaching to this service to evaluate the effects of engagement in the desirable health-related lifestyle on the drug quitting of adolescent drug abusers in Hong Kong.

There will be a target drug abusers service group and peer supporters group. It is expected that the project will receive 1,000 telephone inquiries and provide phone drug abstinence intervention to about 200 drug-abusing youths or young adults and randomized into two groups (100 eligible participants in intervention and eligible 100 participants in control group) and recruit about 80 university students as peer supporters.

To raise anti-drug awareness among young people and identify high-risk/hidden drug-abusing young people aged 35 or below in Hong Kong, there are at least 30,000 pamphlets, booklets and other publicity materials will be delivered to students and teachers at secondary schools and tertiary institutions, to young members of youth organisations and to young employees in high-pressure industries. Approximately 200 secondary and tertiary schools, 50 youth organisations and 50 companies in high-pressure industries will be targeted to introduce the peer-led personalised support programme to teachers, school social workers, students, and young employees and organisation members.

To train university students with medical backgrounds to become peer-led personalised supporters who will implement a brief intervention and provide continual personalised support to help young drug abusers quit drugs.

To implement a peer-led personalised support programme to help young drug abusers quit drugs by using instant messaging applications and a self-determination theory-based intervention

Intervention:

Each participant will then receive a brief intervention over the telephone that will be delivered by a trained peer supporter using the Ask, Warn, Advise, Refer and Do-it-Again (AWARD) model, which was originally developed for primary-care tobacco-cessation interventions. The brief intervention will include the following steps: (1) ask about and assess drug abuse history; (2) warn about the health hazards associated with such health-risk behaviour; (3) advise on how to quit drugs; (4) refer to drug rehabilitation organisations for quitting drugs on request and (5) repeat steps 1 to 4. Participants will be asked about the priority participants place on engagement in health-related lifestyles, such as quitting drugs, alcohol, smoking or exercising regularly. A brief intervention on the selected health-related lifestyle will be given. In addition, participants will be informed that participants will receive instant messaging via WeChat or WhatsApp from peer supporters to assist drug abusers to adhere to schedule of the desirable health-related lifestyle throughout the study period. The duration of the entire intervention will be approximately 5-10 minutes but will be slightly longer if necessary. Such a brief intervention will be cost-effective and more feasible than other interventions for routine use by peer supporters after minimal training. Previous clinical trials of smoking cessation have provided strong evidence on the effectiveness of brief interventions using the AWARD model.

For the first 6 months of the study period, peer supporters will send WhatsApp or WeChat messages approximately once per week to the participants to remind the participants to adhere to schedule of the desirable health-related lifestyle. These messages will be delivered more often, if preferred by the participants. In addition, the participants will receive four independent 1-minute videos (one video will be sent in weeks 1, 5, 12 and 24, respectively) via WhatsApp or WeChat. The video content will focus on the health risks associated with abusing drugs and the benefits of quitting drugs. Participants will be assessed at 1 week, 1 month, 3 months, 6 months, 9 months and 12 months via telephone call. For those participants who have an intention of quitting drugs, participants will be allowed to select preferred quit schedules (quit immediately, or quit progressively, with the ultimate goal of quitting drugs completely).

After 6 months and until 12 months of follow-up, minimal messages will be sent by the peer supporters. These messages will enable the participants' progress to be followed and participants' questions to be answered, and maintain contact with the participants.

Control Group:

Trained peer supporters will answer calls from potential participants and explain the nature and purpose of the project to potential participants. Verbal consent to participate in the project will then be sought from eligible drug abusers. In addition, demographic and baseline data will be obtained. Each participant will then receive a brief intervention over the telephone that will be delivered by a trained peer supporter using the Ask, Warn, Advise, Refer and Do-it-Again (AWARD) model, which was originally developed for primary-care tobacco-cessation interventions. The brief intervention will include the following steps: (1) ask about and assess drug abuse history; (2) warn about the health hazards associated with such health-risk behaviour; (3) advise on how to quit drugs; (4) refer to drug rehabilitation organisations for quitting drugs on request and (5) repeat steps 1 to 4. Participants will be asked to quit drugs immediately or progressively. In addition, participants will be informed that participants will receive instant messaging via WeChat or WhatsApp from peer supporters to assist participants to adhere to schedule of quitting drugs throughout the study period.

For the first 6 months of the study period, peer supporters will send WhatsApp or WeChat messages approximately once per week to the participants to remind participants to adhere to schedule of quitting drugs. These messages will be delivered more often, if preferred by the participants. In addition, the participants will receive four independent 1-minute videos (one video will be sent in weeks 1, 5, 12 and 24, respectively) via WhatsApp or WeChat. The video content will focus on the health risks associated with abusing drugs and the benefits of quitting drugs. Participants will be assessed at 1 week, 1 month, 3 months, 6 months, 9 months and 12 months via telephone call to determine the participants' success in quitting drugs.

After 6 months and until 12 months of follow-up, minimal messages will be sent by the peer supporters. These messages will enable the participants' progress to be followed and participants' questions to be answered, and maintain contact with the participants.

Instruments:

A telephone record sheet will be used to record the incoming telephone calls. Both worldwide validated and self-administered measures (constructed based on previous studies of the PI \& Co-Is and other worldwide validated measures) will be applied in the programme. Callers will be invited to complete a telephone interview in each of the telephone counselling (at baseline, 1-week, 1-month, 3-month, 6-month, 9-month, 12-month). The questionnaire assesses (a) drug abuse profile (quit history, no. of days use, daily drug consumption, etc), (b) drug dependency, (c) contemplation stage of drug abuse abstinence, (d) risk for relapsing, (e) quality of life, (f) withdrawal symptoms, (g) other health-related lifestyles and Demographics will also be asked during the baseline phone interview.

Subject recruitment :

The details of the nature and purpose of the project will be posted at website, secondary schools and tertiary institutions, youth organisations or NGOs, social platform and companies in high-pressure industries to identify potential participants. Young drug abusers will be able to express willingness to join the project by calling the telephone hotline provided. 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 supporter or a research assistant will answer the telephone inquiries from 9:00 a.m. to 5 p.m. on weekdays. Voice mails will be recorded during non-operating hours and public holidays. The hotline centre will close in case of bad weather (e.g. black rainstorm, hoisting of tropical cyclone signal No. 8).

Methods of Statistical Analysis:

Data will be entered and analyzed using IBM SPSS Statistics for Windows or R language programme. A significance level of 0.05 will be adopted. Following the Russell standard, intention-to-treat analysis will performed with the assumption that all participants lost to follow-up had no changes with the status at baseline. All missing data will be handled using multiple imputation.

Descriptive statistics such as frequency, percentage, Chi-square test and/or t-test will be used to measure the outcomes such as reduction of drug abuse consumption and other variables. Longitudinal repeated analysis will be used to measure the trend of drug reduction and other secondary outcome. Exploring subgroup analyses and sensitivity analysis will be performed.

Being tested
Health-risk behaviors, Theory of planned behavior, Self-determination theory, Assist them to adhere to their schedule of quitting drugs throughout the study period, Assist them to adhere to their schedule of desirable health-related lifestyles/quitting drugs throughout the study period, (AWARD) model
Keywords
Health-risk Behaviours, Drug Abuse
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health-risk behaviorsOther

    Participants will be asked about the priority they place on engagement in health-related lifestyles, such as quitting drugs, alcohol, smoking or exercising regularly.

  • Theory of planned behavior, Self-determination theoryOther

    The participants will be asked to quit drugs immediately or progressively with the ultimate goal of quitting drugs completely.

  • Assist them to adhere to their schedule of quitting drugs throughout the study periodOther

    The participants will receive instant messaging via WeChat or WhatsApp from peer supporters to assist them to adhere to their schedule of quitting drugs throughout the study period.

  • Assist them to adhere to their schedule of desirable health-related lifestyles/quitting drugs throughout the study periodOther

    The participants will receive instant messaging via WeChat or WhatsApp from peer supporters to assist them to adhere to their schedule of desirable health-related lifestyles/quitting drugs throughout the study period.

  • (AWARD) modelOther

    Participants receive a brief intervention using the Ask, Warn, Advise, Refer and Do-it-Again (AWARD) model

  • Receive four independent 1-minute videosOther

    The participants will receive four independent 1-minute videos which focus on the health risks associated with abusing drugs and the benefits of quitting drugs.

Study groups in NCT05918601
Study groupRoleWhat they receive
Intervention groupExperimentalEach participant will receive the telephone that will be delivered by a trained peer supporter using the Ask, Warn, Advise, Refer and Do-it-Again (AWARD) model. For the advice steps, participants will be asked about the priority they place on engagement in health-related lifestyles. A brief intervention on the selected health-related lifestyle will be given. In addition, they will be informed that they will receive instant messaging via WeChat or WhatsApp to assist them to adhere to their schedule of the desirable health-related lifestyle throughout the study period. For the first 6 months of the study period, peer supporters will send WhatsApp or WeChat messages approximately once per week to the participants to remind them to adhere to their schedule of the desirable health-related lifestyle. In addition, the participants will receive four independent 1-minute videos which focus on the health risks associated with abusing drugs and the benefits of quitting drugs.
Receives: Other: Health-risk behaviors; Other: Theory of planned behavior, Self-determination theory; Other: Assist them to adhere to their schedule of quitting drugs throughout the study period; Other: Assist them to adhere to their schedule of desirable health-related lifestyles/quitting drugs throughout the study period; Other: (AWARD) model; Other: Receive four independent 1-minute videos
Control GroupPlacebo comparatorTrained peer supporters will answer calls from potential participants and explain the nature and purpose of the project to them. Each participant will then receive a brief intervention over the telephone that will be delivered by a trained peer supporter using the Ask, Warn, Advise, Refer and Do-it-Again (AWARD) model. Participants will be asked to quit drugs immediately or progressively. In addition, they will be informed that they will receive instant messaging via WeChat or WhatsApp from peer supporters to assist them to adhere to their schedule of quitting drugs throughout the study period. For the first six months, participants will receive four independent 1-minute videos which focus on the health risks associated with abusing drugs and the benefits of quitting drugs without any schedule of the desirable health-related lifestyle throughout the study period.
Receives: Other: Theory of planned behavior, Self-determination theory; Other: Assist them to adhere to their schedule of quitting drugs throughout the study period; Other: (AWARD) model; Other: Receive four independent 1-minute videos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Drug Consumption

    Participants' change in drug consumption between baseline and 12-month follow-up will be measured by a structured-questionnaire. The questionnaire gathers the frequency and categories of drug consumption in the past 30 days. The more frequencies and the more kinds of drug used indicating the higher consumption of drug abuse.

    Measured: 12 month

Secondary outcomes (6)
  1. The self-reported drug abuse abstinence rate

    Participants' drug abuse abstinence between baseline, 6-month follow-up and 12-month follow-up will be measured by a structured-questionnaire. The questionnaire gathers the self-reported drug abuse abstinence in the past 30 days (do not use drug for at least 30 days during the time of follow-up).

    Measured: 6 month and 12 month

  2. The change in drug consumption

    Participants' change in drug consumption between baseline and 6-month follow-up will be measured by a structured-questionnaire. The questionnaire gathers the frequency and categories of drug consumption in the past 30 days. The more frequencies and the more kinds of drug used indicating the higher consumption of drug abuse.

    Measured: 6 month

  3. The changes of the contemplation stages at 6-month and 12-month

    Participants' changes of the contemplation stages between baseline, 6-month and 12-month follow-up will be measured by a structured-questionnaire of Contemplation Ladder.

    Measured: 6 month and 12 month

  4. Change of other health-related lifestyles

    Participants' change of other health-related lifestyles for the drug abuser between baseline, 6-month, 12-month follow-up will use a structured-questionnaire to measure their alcohol consumption, smoking consumption, vegetable and fruit consumption and exercising frequency.

    Measured: 6 month and 12 month

  5. The quality of life

    Participants' change of quality of life at baseline, 6-month and 12-month follow-up will use EuroQol 5-level scale (EQ-5D-5L) to measure the quality of life. It consists of two part. The first part has 5 questions and each question has choices 1 to 5. Large number means a worse outcome in the first part. The second part has one question which is a scale of 0 to 100. Large number means a better outcome in the second part.

    Measured: 6 month and 12 month

  6. Peer supporters' improvement in professional knowledge towards counselling and treatment

    Peer supporters' improvement in professional knowledge towards counselling and treatment after the training will be measured by a structured questionnaire in pre-training, immediately after the training and 6-month follow-up

    Measured: immediately after the training and 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start30 Jun 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05918601
Sponsor's protocol ID
NTEC-2023-129
Status last verified
May 2025
First submitted
13 Apr 2023
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Health-risk behaviors, Theory of planned behavior, Self-determination theory and Assist them to adhere to their schedule of quitting drugs throughout the study period in people with Health-risk Behaviours and Drug Abuse, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ho Cheung William Li (39430889, williamli@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Drug Consumption (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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