Mobile EMA-based Peer Counselling for Youth Smokers

Mobile Ecological Momentary Assessment-based Peer Counselling for Youth Smokers: a Pilot Randomised Controlled Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: EMA-based cessation counselling; Behavioral: Usual peer counselling; Behavioral: EMA assessment

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • HKU Youth Quitline

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMA+ group; EMA assessment + EMA-based cessation counselling	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.; 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)
Active Comparator: EMA group; EMA assessment only + 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.; 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-validated tobacco abstinence	Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)	6 months after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 7-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 7 days	3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 7 days	6 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 30 days	3 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 30 days	6 months after randomisation
Smoking reduction by at least 50%	Smoking reduction by at least half of the baseline daily number of cigarettes	3 months after randomisation
Smoking reduction by at least 50%	Smoking reduction by at least half of the baseline daily number of cigarettes	6 months after randomisation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Proportion of participants among all eligible subjects	Through recruitment completion, about 6 months
Retention rate	Proportion of participants responding to telephone follow-up	6 months after randomisation

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
• Chan SS, Wong DC, Fong DY, Leung AY, Lam DO, Mak YW, Lam TH. The establishment and promotion of the first Youth Quitline in Hong Kong: challenges and opportunities. Eval Health Prof. 2008 Sep;31(3):258-71. doi: 10.1177/0163278708320156. Epub 2008 Jun 19.
• Van Zundert RM, Ferguson SG, Shiffman S, Engels R. Dynamic effects of craving and negative affect on adolescent smoking relapse. Health Psychol. 2012 Mar;31(2):226-34. doi: 10.1037/a0025204. Epub 2011 Sep 26.
• McClure EA, Tomko RL, Carpenter MJ, Treiber FA, Gray KM. Acceptability and compliance with a remote monitoring system to track smoking and abstinence among young smokers. Am J Drug Alcohol Abuse. 2018;44(5):561-570. doi: 10.1080/00952990.2018.1467431. Epub 2018 May 8.
• Fanshawe TR, Halliwell W, Lindson N, Aveyard P, Livingstone-Banks J, Hartmann-Boyce J. Tobacco cessation interventions for young people. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD003289. doi: 10.1002/14651858.CD003289.pub6.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: mobile health; Chinese; counselling; ecological momentary assessment; quitline; young smoker; adolescsent
• Other Study ID Numbers: 202111159206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No