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A feasibility study to test the feasibility and acceptability of a peer-led school-based smoking prevention intervention for adolescents

Feasibility study of a peer-led, school-based, adolescent smoking prevention intervention (ASSIST) in culturally different middle-income countries

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99140476
Enrollment
3000
Registered
2023-09-28
Start date
2023-10-16
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent smoking prevention Other

Interventions

Current interventions as of 04/10/2023: This study will use cluster randomisation at the school level, with 10 schools being randomised to the intervention or control arms (six intervention and four c

Sponsors

University of Glasgow
Lead Sponsor
De La Salle University
Collaborator
Gadjah Mada University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 14/10/2024: Both state and privately funded schools in each of the three countries will be eligible. All students in the target year group who are active in school (whether smokers, non-smokers or experience of smoking) will be eligible to take part _____ Previous participant inclusion criteria as of 04/10/2023: 1. State and privately funded schools in each of the two countries 2. All students (aged 13-14 years old) who are active in school (whether smokers, non-smokers or experience of smoking) _____ Previous participant inclusion criteria: 1. State and privately funded schools in each of the three countries 2. All students (aged 13-14 years old) who are active in school (whether smokers, non-smokers or experience of smoking)

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 14/10/2024: Schools: 1. For reasons of practicality school year group size will be limited to 500 2. Schools with school year groups smaller than 100 will be excluded 3. Schools with limited or poor internet access due to potential requirement to run study remotely if the COVID-19 situation dictates. 4. No single-sex schools (due to the low rates of girls smoking in some countries and also the important influence of the other gender on smoking behaviour). Individual students: 1. Any student identified by the researchers, in consultation with teaching staff, as not having the mental and emotional capacity to consent and fully engage in the research will not be included. If a change in mental or emotional capacity occurs during the course of the study, making it difficult for students to take part, then they can be withdrawn from the research process on advice from teaching staff. 2. Other reasons for student ineligibility to consent may include learning difficulties, level of literacy and language comprehension issues. _____ Previous exclusion criteria: Schools: 1. For reasons of practicality school year group size will be limited to 500 2. Schools with school year groups smaller than 100 will be excluded 3. Schools with limited or poor internet access due to potential requirement to run study remotely if the COVID-19 situation dictates. 4. No single-sex schools (due to the low rates of girls smoking in some countries and also the important influence of the other gender on smoking behaviour). Individual students: 1. Any student identified by the researchers, in consultation with teaching staff, as not having the mental and emotional capacity to consent and fully engage in the research will not be included. If a change in mental or emotional capacity occurs during the course of the study, making it difficult for students to take part, then they can be withdrawn from the research process on advice from teaching staff.

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 04/10/2023: 1. Attainment of pre-set progression criteria to progress to a full trial measured using different sources of evidence including baseline and follow-up questionnaires, a peer supporter questionnaire, interviews, attendance logs, social network analysis, researcher records, and data collection records at various timepoints throughout the study. The progression criteria are as outlined below and there will be red/amber/green cut-offs: 1.1. Intervention acceptability and feasibility (in intervention schools) 1.1.1. Feasibility to recruit and train peer supporters measured using attendance monitoring at recruitment meetings and with training attendance logs and social network analysis 1.1.2. Ability of peer supporters to carry out the role measured using peer supporter questionnaire, follow-up attendance log, and peer supporter interviews 1.1.3. Usefulness of the ASSIST intervention to the wider target group measured using study study-developed questionnaire at a 7-month follow-up 1.1.4. Acceptability of the ASSIST Global intervention to parents/careers of peer supporters measured using peer supporter questionnaire, teacher interviews, and peer supporter interviews 1.1.5. Acceptability of the ASSIST Global intervention to participating schools measured using teacher interviews 1.2. School and participant recruitment and retention 1.2.1. Recruitment of the required number of schools measured using researcher records 1.2.2. Acceptability of the ASSIST Global study methodology to participating schools measured using teacher interviews 1.2.3. Retention of schools measured using retention records 1.3. Primary outcome measurements 1.3.1. Acceptability of opt-out rates measured using school records, and study records of opt-out (data collection records) 1.3.2. Acceptability and feasibility of questionnaires to students measured using a study-developed questionnaire at baseline and 7-month follow-up 1.3.3. Likelihood of prima

Secondary

MeasureTime frame
1. Smoking behaviour of friends and family measured using a study-developed questionnaire at baseline and 7 months 2. E-cigarette/vaping and other forms of tobacco use measured using a study-developed questionnaire at baseline and 7 months 3. Smoking-related attitudes and knowledge measured using a study-developed questionnaire at baseline and 7 months 4. Smoking norms measured using a study-developed questionnaire at baseline and 7 months 5. Self-esteem measured using a study-developed questionnaire at baseline and 7 months 6. Spillover effects on parents and other family members they live with, measured using a study-developed questionnaire at 7 months 7. Self-efficacy measured using the Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) at baseline and 7 months 8. Socio-demographics measured using a study-developed questionnaire at baseline 9. Exhaled carbon monoxide (eCO) measured using Smokelyser Micro+ at 7 months

Countries

China, Indonesia, Philippines

Contacts

Public ContactYin Nwe Soe
YinNwe.Soe@glasgow.ac.uk+44 (0)141 353 7500

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026