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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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11 February 2019 |
Main ID: |
ISRCTN14415936 |
Date of registration:
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05/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Adapting and piloting the ASSIST model of informal peer-led intervention delivery to the Talk to Frank drug prevention programme in UK secondary schools (ASSIST+Frank)
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Scientific title:
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Adapting and piloting the ASSIST model of informal peer-led intervention delivery to the Talk to Frank drug prevention programme in UK secondary schools (ASSIST+Frank): intervention development and a pilot trial |
Date of first enrolment:
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01/03/2014 |
Target sample size:
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1632 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN14415936 |
Study type:
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Interventional |
Study design:
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Intervention development followed by a four-arm pilot cluster randomized trial (at the level of school) with an embedded process evaluation (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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James
White |
Address:
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South East Wales Trials Unit (SEWTU)
School of Medicine
Cardiff University
4th Floor Neuadd Meirionnydd
Heath Park
CF14 4YS
Cardiff
United Kingdom |
Telephone:
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+44 (0)29 2068 7243/875184 |
Email:
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whitej11@cf.ac.uk |
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Key inclusion & exclusion criteria
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Inclusion criteria: Schools will be eligible for inclusion if they are among the state secondary schools identified by Welsh Government and Public Health Wales as receiving ASSIST in the 2014-2015 academic year. Students in Year 8 in these schools in 2014-2015 will be eligible participants in baseline and follow-up data collections (baseline conducted in Year 8; 18-month follow-up Year 9)
Exclusion criteria: Students who refuse their consent, or whose parents/carers refuse consent
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Illicit drug use Mental and Behavioural Disorders
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Intervention(s)
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ASSIST is an informal peer-led smoking prevention intervention to diffuse and sustain non-smoking norms via secondary school students? social networks in Year 8 (aged 12-13).
ASSIST has five stages:
1. Nomination of peer supporters: Students aged 12?13 years (UK year 8) are asked to identify influential peers using three questions, ?Who do you respect in year 8 at your school??, ?Who are good leaders in sports or other groups activities in year 8 at your school??, and ?Who do you look up to in year 8 at your school?? The 17.5% of year 8 pupils receiving the most peer nominations are invited to a recruitment meeting.
2. Recruitment of peer supporters: A meeting is held with nominees to explain the role of a peer supporter and answer questions. Trainers make it clear that students who smoke can only be peer supporters if they commit to trying to stop smoking.
3. Training of peer supporters: The aims of the training are to: provide information about the risks of smoking and the benefits of remaining smoke-free; develop communication skills including listening, cooperation and negotiation, and conflict resolution; enhance students? confidence, empathy, assertiveness, attitudes to risk-taking, and exploration of personal values and to role play having informal conversations about smoking with their peers. Training takes place at a venue outside school over 2 days by a team of external trainers experienced in youth work and health promotion.
4. Intervention period: 10-week peer-led intervention where supporters have informal conversations with their peers on smoking when travelling to and from school, in breaks, at lunchtime, and after school in their free time, and log a record of these conversations in a pro-forma diary. Four follow-up school visits by trainers to meet with peer supporters and provide them with additional support and training and to review progress wit
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Primary Outcome(s)
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The progression criteria on which the decision to proceed to a definitive trial are our primary outcomes. These are:
Acceptability and feasibility of the interventions to school and intervention delivery staff
1. Was it feasible to implement the ASSIST+Frank intervention in (at least) two out of three intervention schools? This will be assessed according to whether: a) 75%+ of year 8 ASSIST peer supporters are recruited and re-trained as ASSIST+Frank peer supporters in year 9; b) 75%+ of year 9 students nominated are recruited and trained as Frank friends peer supporters and, c) PHW staff delivered the additional ASSIST+Frank training in full in all three intervention schools. This will be assessed via interviews and focus groups with peer supporters and PHW staff, as well as observations of peer supporter training.
2. Was it feasible to implement the Frank friends intervention in (at least) two out of three intervention schools? This will be assessed according to whether: a) PHW staff delivered the Frank friends training in full in all three schools. This will be assessed via interviews and focus groups with peer supporters and PHW staff, as well as observations of peer supporter training.
Acceptability of the intervention to peer supporters and fidelity
3. Was the intervention acceptable to students trained as ASSIST+Frank peer supporters? This will be assessed according to whether: a) 75%+ of ASSIST+Frank peer supporters report having at least one or more informal conversations with their peers at school about drug-related risks/harms; and b) 75%+ of ASSIST+Frank peer supporters report at least one contact with PHW staff, either via a follow-up visit and/or contact via email, text or Facebook. This will be assessed via interviews and focus groups with peer supporters and PHW staff, and analysis of documentary evidence (e.g. PHW log of attendance at follow-ups, etc.).
4. Was the intervention acceptable to students trained as Frank friends peer supporters? This will be assessed according to whether: a) 75%+ of Frank friends peer supporters report having at least one or more informal conversations with their peers at school about drug-related risks/harms; and b) 75%+ of Frank friends peer supporters report ongoing contact with PHW staff throughout the year via a follow-up visit. This will be assessed via interviews and focus groups with peer supporters and PHW staff, and analysis of documentary evidence (e.g. PHW log of attendance at follow-ups, etc.).
Acceptability of the intervention to school staff and parents
5. Was the ASSIST+Frank intervention acceptable to the majority of school senior management teams (SMT), other school staff, and parents? This will be assessed via interviews with SMT and focus groups with school staff and parents.
6. Was the Frank friends intervention acceptable to the majority of school senior management teams (SMT), other school staff, and parents? This will be assessed via interviews with SMT and focus groups with school staff and parents.
Acceptability of the trial design and assessment methods
7. Were the trial design and methods acceptable and feasible? This will be assessed according to whether: a) randomization occurred as planned and was acceptable to SMTs; b) a minimum of five out of six intervention schools and two out of three schools from the comparison arms participate up in the 18-month follow-up? and, c) the student survey response rates are acceptable at baseline (80%+) and follow-up (75%+).
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Secondary Outcome(s)
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Incidence of any illicit drug use assessed by self-report questionnaire 18 months after randomisation. Use of cannabis, cocaine, amphetamines, crack, ecstasy, aerosols, gas, glue, solvents, poppers, nitrus oxide, sedatives or sleeping pills, LSD, magic mushrooms, ketamine, steroids, methadrone, other prescription drugs, and opioids. Questions will assess use: ever (lifetime prevalence), over the past 12 months, past 30 days and past week; Age of first experimentation with any drug; Cannabis use: age of first use; frequency of use; symptoms after use (e.g. anxiety, relaxation, paranoia); method of use (by itself, mixed with tobacco); cannabis dependence: Cannabis Abuse Screen Test (CAST); Tobacco use: lifetime use; current use; use in past 12 months, past 30 days and past week; frequency of use; (taken from ASSIST trial and Health Survey for England); Heaviness of Smoking Index; Fagerstrom test of nicotine dependence.
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Secondary ID(s)
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12/3060/03
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Source(s) of Monetary Support
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National Institute for Health Research (NIHR) (UK) - Public Health Research Programme (PHR) (ref: 12/3060/03)
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Ethics review
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Status:
Approval date:
Contact:
School of Social Sciences Ethics Committee, 09/09/2013, ref: SREC/1103
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/09/2016 |
URL:
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