The FRANK friends study: a multicentre cluster randomised controlled trial evaluating a school-based drug prevention intervention
| ISRCTN | ISRCTN72047541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72047541 |
| Secondary identifying numbers | CTR internal ref: 739 |
- Submission date
- 25/06/2019
- Registration date
- 23/08/2019
- Last edited
- 09/05/2022
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Other
Plain English summary of protocol
Current plain English summary as of 09/01/2020:
Background and study aims
The latest UK data indicate that 37% of 15 year olds have ever tried an illicit drug. There are short-term as well as long-term effects on health arising from illicit drug use amongst young people. Schools provide a systematic and efficient way of reaching a large number of people every year. Studies evaluating school-based drug prevention interventions have found few prevent or reduce student drug use, with only a handful taking place in the UK. In response, an effective school-based peer-led smoking prevention intervention (ASSIST) that has been delivered to around 120,000 UK students was adapted to deliver information from the UK national drug education website: www.talktofrank.com. In interviews and focus groups in the pilot study of this intervention, students, teachers, and parents, all thought the intervention was acceptable, easy to deliver and could have promising effects on drug use. The pilot study was too small to evaluate whether FRANK friends could prevent drug use, so the researchers are now conducting a larger trial to evaluate effects on illicit drug use will be conducted. This trial will introduce and evaluate FRANK Friends (the “intervention”) which is a school-based peer-led drug prevention intervention.
Who can participate?
Students in UK Year 9 (aged 13-14)
What does the study involve?
In each school, students in UK year 9 (aged 13-14) will be asked to nominate fellow students who they think are influential. Students in receipt of the top 17.5% of nominations are asked to become peer supporters. Those who agree receive 2-days training out of school on the effects and risks associated with specific drugs, minimising potential harms, and the law using material taken from www.talktofrank.com. Peer supporters practise communication skills including, listening, negotiation, and how to talk with their peer group about drugs. They are then asked to have conversations about the harms of drug use with their peers over a 10-week period and record them in a diary. During these 10-weeks peer supporters receive four follow-up visits from trainers at school to provide support.
There will be 40 schools in the trial and they will be randomly split into two groups, 20 schools will receive the intervention and 20 will form a comparison group, and will continue with usual practice, the trial will include about 7242 students.
Before the intervention is delivered, questionnaire data will be collected from all students in year 9. In these questionnaires the use of drugs ever, in the past year, and in the past month will be measured as well as lifetime and weekly smoking, and quality of life. These things will be measured again 24 months after the intervention is delivered. The researchers will be looking to see if there are positive changes in student drug use, and whether these changes are greater within schools that received the intervention compared to schools that did not. Interviews with peer supporters, other students and trainers will also be conducted and training sessions will be observed to explore what happened during the training, how people feel about the intervention, and in what ways it has been useful. Finally, the cost of the intervention will be calculated, and weighed up against any benefits in terms of student drug use, to see if it provides good value for money.
What are the possible benefits and risks of participating?
If effective, the FRANK friends intervention will prevent drug use onset by the age of 15 and reduce the frequency of drug use amongst students. These effects could lead to improvements in health including reducing the risk of drug dependence, poor lung function, and symptoms of psychosis, and involvement in the criminal justice system. There may be additional benefits for peer supporters. In the pilot study, teachers and parents reported that peer supporters improved their communication skills, became more confident and more involved with school activities (e.g. school councils). Potential risks of the intervention to participants are minimal. Some individuals might find aspects of intervention content or research upsetting if they, or a significant other, have experienced a problem in relation to drug use. Trial managers will work with schools to ensure a system is in place to enable appropriate support to be provided in such circumstances. Any potential for harmful effects due to the intervention itself will be explored via the collection and analysis of qualitative data to explore unintended consequences.
Where is the study run from?
1. Cardiff University (UK)
2. University of Bristol (UK)
When is the study starting and how long is it expected to run for?
March 2019 to April 2022
Who is funding the study?
1. Public Health Research Programme
2. Public Health Wales
3. NIHR Clinical Research Network (CRN): West of England
4. South Gloucestershire Council
5. Bath & North East Somerset Council
Who is the main contact?
Dr James White
whitej11@cf.ac.uk
_____
Previous plain English summary:
Background and study aims
The latest UK data indicate that 37% of 15 year olds have ever tried an illicit drug. There are short-term as well as long-term effects on health arising from illicit drug use amongst young people. Schools provide a systematic and efficient way of reaching a large number of people every year. Studies evaluating school-based drug prevention interventions have found few prevent or reduce student drug use, with only a handful taking place in the UK. In response, an effective school-based peer-led smoking prevention intervention (ASSIST) that has been delivered to around 120,000 UK students was adapted to deliver information from the UK national drug education website: www.talktofrank.com. In interviews and focus groups in the pilot study of this intervention, students, teachers, and parents, all thought the intervention was acceptable, easy to deliver and could have promising effects on drug use. The pilot study was too small to evaluate whether FRANK friends could prevent drug use, so the researchers are now conducting a larger trial to evaluate effects on illicit drug use will be conducted. This trial will introduce and evaluate FRANK Friends (the “intervention”) which is a school-based peer-led drug prevention intervention.
Who can participate?
Students in UK Year 9 (aged 13-14)
What does the study involve?
In each school, students in UK year 9 (aged 13-14) will be asked to nominate fellow students who they think are influential. Students in receipt of the top 17.5% of nominations are asked to become peer supporters. Those who agree receive 2-days training out of school on the effects and risks associated with specific drugs, minimising potential harms, and the law using material taken from www.talktofrank.com. Peer supporters practise communication skills including, listening, negotiation, and how to talk with their peer group about drugs. They are then asked to have conversations about the harms of drug use with their peers over a 10-week period and record them in a diary. During these 10-weeks peer supporters receive four follow-up visits from trainers at school to provide support. There will be 48 schools in the trial and they will be randomly split into two groups, 24 schools will receive the intervention and 24 will form a comparison group, and will continue with usual practice, the trial will include about 5655 students.
Before the intervention is delivered, questionnaire data will be collected from all students in year 9. In these questionnaires the use of drugs ever, in the past year, and in the past month will be measured as well as lifetime and weekly smoking, and quality of life. These things will be measured again 24 months after the intervention is delivered. The researchers will be looking to see if there are positive changes in student drug use, and whether these changes are greater within schools that received the intervention compared to schools that did not. Interviews with peer supporters, other students and trainers will also be conducted and training sessions will be observed to explore what happened during the training, how people feel about the intervention, and in what ways it has been useful. Finally, the cost of the intervention will be calculated, and weighed up against any benefits in terms of student drug use, to see if it provides good value for money.
What are the possible benefits and risks of participating?
If effective, the FRANK friends intervention will prevent drug use onset by the age of 15 and reduce the frequency of drug use amongst students. These effects could lead to improvements in health including reducing the risk of drug dependence, poor lung function, and symptoms of psychosis, and involvement in the criminal justice system. There may be additional benefits for peer supporters. In the pilot study, teachers and parents reported that peer supporters improved their communication skills, became more confident and more involved with school activities (e.g. school councils). Potential risks of the intervention to participants are minimal. Some individuals might find aspects of intervention content or research upsetting if they, or a significant other, have experienced a problem in relation to drug use. Trial managers will work with schools to ensure a system is in place to enable appropriate support to be provided in such circumstances. Any potential for harmful effects due to the intervention itself will be explored via the collection and analysis of qualitative data to explore unintended consequences.
Where is the study run from?
1. Cardiff University (UK)
2. University of Bristol (UK)
When is the study starting and how long is it expected to run for?
March 2019 to June 2022
Who is funding the study?
1. Public Health Research Programme
2. Public Health Wales
3. NIHR Clinical Research Network (CRN): West of England
4. South Gloucestershire Council
5. Bath & North East Somerset Council
Who is the main contact?
Dr James White
whitej11@cf.ac.uk
Contact information
Public
Centre for Trials Research (CTR)
Cardiff University
4th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
 ORCID ID |
0000-0001-8371-8453 |
|---|---|
| Phone | +44 (0)29 20 687054 |
| whitej11@cf.ac.uk |
Scientific
Centre for Trials Research (CTR)
Cardiff University
4th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
| ORCID ID |
0000-0001-8371-8453 |
|---|---|
| Phone | +44 (0)29 20 687054 |
| whitej11@cf.ac.uk |
Study information
| Study design | Parallel-group multicentre two-arm cluster RCT with process and economic evaluations |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a school-based peer-led drug prevention intervention |
| Study acronym | FRANK friends |
| Study objectives | Primary objective: To investigate whether the FRANK Friends intervention prevents the use of any illicit drug compared to usual practice at the 24-month follow-up. |
| Ethics approval(s) | 1. Approved 11/06/2019, Cardiff University, School of Social Sciences Research Ethics Committee (Glamorgan Building, King Edwards VII Avenue, Cardiff, CF10 3WT, Wales, UK; Tel: +44(0)29 2087 5179), ref: SREC/3342 2. Amendment approved 10/12/2019, Cardiff University, School of Social Sciences Research Ethics Committee (Glamorgan Building, King Edwards VII Avenue, Cardiff, CF10 3WT, Wales, UK; Tel: +44(0)29 2087 5179), ref: SREC/3342 (added 09/01/2020). |
| Health condition(s) or problem(s) studied | Prevention of illicit drugs |
| Intervention | Current interventions as of 09/01/2020: This trial will introduce and evaluate FRANK Friends (the “intervention”) which is a school-based peer-led drug prevention intervention. In each school, students in UK year 9 (aged 13-14) will be asked to nominate fellow students who they think are influential. Students in receipt of the top 17.5% of nominations are asked to become peer supporters. Those who agree receive 2 days training out of school on the effects and risks associated with specific drugs, minimising potential harms, and the law using material taken from www.talktofrank.com. Peer supporters practise communication skills including, listening, negotiation, and how to talk with their peer group about drugs. They are then asked to have conversations about the harms of drug use with their peers over a 10-week period and record them in a diary. During these 10-weeks peer supporters receive four follow-up visits from trainers at school to provide support. There will be 40 schools in the trial and they will be randomly split into two groups, 20 schools will receive the intervention and 20 will form a comparison group, and will continue with usual practice, the trial will include about 7242 students. Before the intervention is delivered, questionnaire data will be collected from all students in year 9. In these questionnaires the use of drugs ever, in the past year, and in the past month will be measured as well as lifetime and weekly smoking, and quality of life. These things will be measured again 24 months after the intervention is delivered. The researchers will be looking to see if there are positive changes in student drug use, and whether these changes are greater within schools that received the intervention compared to schools that did not. Interviews with peer supporters, other students and trainers will also be conducted and training sessions will be observed to explore what happened during the training, how people feel about the intervention, and in what ways it has been useful. Finally, the cost of the intervention will be calculated and weighed up against any benefits in terms of student drug use, to see if it provides good value for money. _____ Previous interventions: This trial will introduce and evaluate FRANK Friends (the “intervention”) which is a school-based peer-led drug prevention intervention. In each school, students in UK year 9 (aged 13-14) will be asked to nominate fellow students who they think are influential. Students in receipt of the top 17.5% of nominations are asked to become peer supporters. Those who agree receive 2 days training out of school on the effects and risks associated with specific drugs, minimising potential harms, and the law using material taken from www.talktofrank.com. Peer supporters practise communication skills including, listening, negotiation, and how to talk with their peer group about drugs. They are then asked to have conversations about the harms of drug use with their peers over a 10-week period and record them in a diary. During these 10-weeks peer supporters receive four follow-up visits from trainers at school to provide support. There will be 48 schools in the trial and they will be randomly split into two groups, 24 schools will receive the intervention, and 24 will form a comparison group, and will continue with usual practice, the trial will include approximately 5655 students. Before the intervention is delivered, questionnaire data will be collected from all students in year 9. In these questionnaires the use of drugs ever, in the past year, and in the past month will be measured as well as lifetime and weekly smoking, and quality of life. These things will be measured again 24 months after the intervention is delivered. The researchers will be looking to see if there are positive changes in student drug use, and whether these changes are greater within schools that received the intervention compared to schools that did not. Interviews with peer supporters, other students and trainers will also be conducted and training sessions will be observed to explore what happened during the training, how people feel about the intervention, and in what ways it has been useful. Finally, the cost of the intervention will be calculated, and weighed up against any benefits in terms of student drug use, to see if it provides good value for money. |
| Intervention type | Behavioural |
| Primary outcome measure | Lifetime illicit drug use is assessed using a self-report questionnaire at baseline and a 24-month follow-up |
| Secondary outcome measures | 1. The use of any illicit drug over the past 12 months, past month and week assessed using self-report questionnaires at baseline and a 24-month follow-up 2. The use of specific illicit drugs over the past 12 months, past month and week assessed using self-report questionnaires at baseline and a 24-month follow-up 3. The frequency of use of any illicit drug over the past 12 months, past month and week assessed using self-report questionnaires at baseline and a 24-month follow-up 4. The frequency of use of specific illicit drugs over the past 12 months, past month and week assessed using self-report questionnaires at baseline and a 24-month follow-up. 5. Cannabis dependency assessed using the Cannabis Abuse Screen Test (CAST) at baseline and a 24-month follow-up 6. Smoking (lifetime and weekly smoking status) assessed using a self-report questionnaire at baseline and a 24-month follow-up (weekly smoking defined as usually smoking ≥ one cigarette a week) 7. The frequency of alcohol consumption (past 12 months, month and week) assessed using a self-report questionnaire at baseline and a 24-month follow-up 8. Alcohol use disorder defined as consuming ≥ 3 whole alcoholic drinks in the past year using a self-report on the frequency of alcohol consumption at baseline and a 24-month follow-up 9. Health-related quality of life assessed using the Child Health Utility 9D using a self-report questionnaire at baseline and a 24-month follow-up |
| Overall study start date | 01/03/2019 |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 7242 |
| Total final enrolment | 6754 |
| Key inclusion criteria | Students in UK Year 9 (aged 13-14) |
| Key exclusion criteria | 1. Fee-paying schools 2. Special schools (e.g. for those with learning disabilities) 3. Pupil referral units 4. Schools with less than 60 students in Year 9 5. Schools likely to be closed or merged during the trial 6. Those that received the FRANK friends intervention in the pilot |
| Date of first enrolment | 01/09/2019 |
| Date of final enrolment | 01/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Cardiff University
4th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Bristol Medical School
University of Bristol
Canynge Hall (room 4.09)
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Sponsor information
University/education
Research and Innovation Services
McKenzie House
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Phone | +44 (0)29 20875834 |
|---|---|
| resgov@cardiff.ac.uk | |
| Website | https://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Public Health Research Programme, PHR
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- Iechyd Cyhoeddus Cymru, Public Health Wales NHS Trust, PHW
- Location
- United Kingdom
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Exact details of the publication policy are still being developed. However, broadly the researchers plan on publishing the protocol paper in a peer review journal once they are into recruitment (Summer/Autumn 2019), the main trial results and process evaluation in high impact journals at the end of the trial (post 30/06/2022). Findings will be presented to people who are involved in drug prevention in the UK (e.g. parents, public health teams, teachers, charities (e.g. Off the Record, Bristol Drugs Project) policy-makers) as well as at scientific conferences. If effective, avenues for delivering the intervention to other schools across the UK will be explored. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr James White (whitej11@cf.ac.uk). |
Editorial Notes
09/05/2022: Forty schools in England and Wales were recruited, randomised, and baseline data collected from 6,754 students (response rate = 94.5%). By March 2020 intervention delivery was complete in five schools and started in another eight. The UK wide lockdown resulted in the cancellation of all remining intervention delivery sessions. In June 2020, the Trial Management Group decided the impact of COVID-19 related delays on intervention delivery was likely to reduce the effectiveness of the intervention to such an extent that it was no longer scientifically sensible to continue with the cohort of recruited students. The study was therefore placed on hold and all trial staff were made redundant or redeployed onto other studies. All schools were informed that the study would close on 30/11/2020. The study was formally closed in May 2022.
12/04/2022: The overall trial end date has been changed from 30/06/2022 to 07/04/2022 and the plain English summary has been updated accordingly.
24/11/2020: In March 2020, in response to the COVID-19 pandemic, the UK and Welsh governments closed all schools. This meant the FRANK friends intervention could no longer be delivered. Prior to school closures, the intervention was delivered in full to five out of the 20 schools the researchers had intended. The FRANK Friends Trial Management Group did not believe this was enough schools to be able to detect any effects and recommended the study be closed. The Trial Steering Committee agreed with these recommendations. The researchers are working with their funder to plan how the study will restart. If you have any questions about the study or data, please contact Dr James White (whitej11@cardiff.ac.uk).
11/06/2020: Total final enrolment number added.
09/01/2020: The following changes were made to the trial record:
1. The ethics approval was updated with an amendment.
2. The interventions were changed.
3. The target number of participants was changed from 5655 to 7242.
4. The plain English summary was updated to reflect these changes.
08/01/2020: The recruitment end date has been changed from 01/12/2019 to 01/03/2020.
04/11/2019: The recruitment end date has been changed from 31/10/2019 to 01/12/2019.
09/07/2019: Trial's existence confirmed by ethics committee and funder.
