Mobile EMA-based Peer Counselling for Youth Smokers

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05732220
• Other study ID #: 202111159206
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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)
• 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.
• 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.

Locations

Country	Name	City	State
Hong Kong	HKU Youth Quitline	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recruitment rate	Proportion of participants among all eligible subjects	Through recruitment completion, about 6 months
Other	Retention rate	Proportion of participants responding to telephone follow-up	6 months after randomisation
Primary	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	Self-reported 7-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 7 days	3 months after randomisation
Secondary	Self-reported 7-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 7 days	6 months after randomisation
Secondary	Self-reported 30-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 30 days	3 months after randomisation
Secondary	Self-reported 30-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 30 days	6 months after randomisation
Secondary	Smoking reduction by at least 50%	Smoking reduction by at least half of the baseline daily number of cigarettes	3 months after randomisation
Secondary	Smoking reduction by at least 50%	Smoking reduction by at least half of the baseline daily number of cigarettes	6 months after randomisation