Mobile EMA-based Peer Counselling for Youth Smokers

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05732220
Collaborator
(none)
105
3
18

Study Details

Study Description

Brief Summary

This pilot trial aims to examine the feasibility, acceptability, and preliminary effectiveness of EMA-based peer counseling for youth smokers.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: EMA assessment
  • Behavioral: EMA-based cessation counselling
  • Behavioral: Usual peer counselling
N/A

Detailed Description

Most smokers begin smoking during adolescence and early adulthood, a crucial period to prevent initiation and continuation of smoking. However, many proven smoking cessation interventions for adult smokers were not found effective in youth smokers, which may be partly explained by the vast differences in the pattern of tobacco use and determinants of quitting between adult and youth smokers. This calls for more research on novel intervention models to help young smokers quit.

The HKU Youth Quitline provides free smoking cessation support for smokers aged below 25 years since August 2005 in Hong Kong. The service provides multisession peer-led telephone counselling with an individualised quit plan devised for each young smoker according to their responses. Since the counselling model depends on the information retrospectively recalled by the smokers, it may be prone to recall and social desirability biases and fail to capture the variability of youth smoking patterns and momentary changes in personal (e.g., mood) and situational (e.g., peer smoking) antecedents of smoking episodes.

Recent advances in mobile technologies have enabled the use of more advanced and robust data collection approaches like ecological momentary assessment (EMA), which may benefit the counselling model by providing more ecologically valid data than traditional surveys. Previous studies have demonstrated the feasibility of using EMA to collect data on psychosocial processes and smoking behaviours in adolescent smokers. Therefore, we propose to develop and test a mobile EMA-based counselling intervention for youth smokers by conducting a pilot RCT.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mobile Ecological Momentary Assessment-based Peer Counselling for Youth Smokers: a Pilot Randomised Controlled Trial
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
May 15, 2024
Anticipated Study Completion Date :
Aug 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: EMA+ group

EMA assessment + EMA-based cessation counselling

Behavioral: EMA assessment
Subjects will be asked to complete 3 waves of ecological momentary assessment (EMA) about smoking cues and smoking consumption via mobile phone at the first, second and third month after baseline (total 6 weeks)

Behavioral: EMA-based cessation counselling
Subjects will receive tailored peer counselling based on the participants' EMA responses at 1-month and 3-month telephone follow-ups.

Active Comparator: EMA group

EMA assessment only + Usual peer counselling

Behavioral: EMA assessment
Subjects will be asked to complete 3 waves of ecological momentary assessment (EMA) about smoking cues and smoking consumption via mobile phone at the first, second and third month after baseline (total 6 weeks)

Behavioral: Usual peer counselling
Subjects will receive peer counselling through telephone during follow-ups (usual care), in which the counsellor will apply the 5As model and motivational interviewing techniques.

Active Comparator: Control

Usual peer counselling

Behavioral: Usual peer counselling
Subjects will receive peer counselling through telephone during follow-ups (usual care), in which the counsellor will apply the 5As model and motivational interviewing techniques.

Outcome Measures

Primary Outcome Measures

  1. Biochemically-validated tobacco abstinence [6 months after randomisation]

    Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)

Secondary Outcome Measures

  1. Self-reported 7-day point-prevalence tobacco abstinence [3 months after randomisation]

    Being completely smoke-free in the past 7 days

  2. Self-reported 7-day point-prevalence tobacco abstinence [6 months after randomisation]

    Being completely smoke-free in the past 7 days

  3. Self-reported 30-day point-prevalence tobacco abstinence [3 months after randomisation]

    Being completely smoke-free in the past 30 days

  4. Self-reported 30-day point-prevalence tobacco abstinence [6 months after randomisation]

    Being completely smoke-free in the past 30 days

  5. Smoking reduction by at least 50% [3 months after randomisation]

    Smoking reduction by at least half of the baseline daily number of cigarettes

  6. Smoking reduction by at least 50% [6 months after randomisation]

    Smoking reduction by at least half of the baseline daily number of cigarettes

Other Outcome Measures

  1. Recruitment rate [Through recruitment completion, about 6 months]

    Proportion of participants among all eligible subjects

  2. Retention rate [6 months after randomisation]

    Proportion of participants responding to telephone follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age between 15 to 25 years

  2. Have smoked in the past 30 days

  3. Own a smartphone with an mobile instant messaging app installed

  4. Can communicate in Chinese

Exclusion Criteria:

Youth smokers who are participating in other smoking cessation studies or program other than the HKU Youth Quitline

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tzu Tsun Luk, Research Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05732220
Other Study ID Numbers:
  • 202111159206
First Posted:
Feb 16, 2023
Last Update Posted:
Feb 22, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tzu Tsun Luk, Research Assistant Professor, The University of Hong Kong

Study Results

No Results Posted as of Feb 22, 2023