Impact of an Interactive Film-based Intervention on Resilience, Mental Wellbeing and Help-seeking Attitudes in Young People (14-18) At School Settings in North East of England: a Mixed-methods Cluster Randomised Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Willingness of schools to participate and be randomised
研究概览
简要总结
The primary aim of this study is to assess the feasibility and acceptability of a randomised controlled trial of an interactive film intervention (commissioned through a North East and North Cumbria Child (NENC) Health & Wellbeing Network partnership and produced by Trylife), on building resilience, enhancing mental wellbeing and help-seeking attitudes for young people (14-18 years) in schools located in deprived areas of the North East and North Cumbria.
详细描述
Study Objectives:
- To conduct a three-arm feasibility trial to assess the feasibility of a brief interactive film intervention in school settings with randomisation at school level.
- To explore suitability of parameters of the trial, such as school recruitment, school randomisation, participant recruitment and retention, consent taking, data collection tools, feasibility and acceptability of the intervention, with a view of developing a large-scale trial, as primary outcome.
- To explore views and experiences of young people on acceptability and implementation of the trial and the film intervention through using a qualitative design.
- To gather preliminary data on the effectiveness of a brief interactive film intervention in school settings to enhance resilience, help-seeking attitudes and mental wellbeing in young people, as a secondary outcome.
Design Mixed-methods three arm feasibility cluster randomised controlled trial to assess the feasibility and acceptability of intervention delivery and study procedures, including the following key parameters: school recruitment and randomisation, sample size and participant recruitment and retention, consent taking, data collection tools, data analysis, intervention acceptability and delivery.
Setting Three schools across North East England and North Cumbria will be recruited, matched on size and socio-economic status, measured by percentage of children entitled to free meal.
School recruitment Schools will be recruited by telephoning and emailing head teachers at appropriate points of contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In selected Y10 or Y12 class (at start of study) at participating school
排除标准
- •Lack of parental consent for Y10 students
结局指标
主要结局
Willingness of schools to participate and be randomised
时间窗: Qualitative data collection phase, month 20-23
The qualitative assessment will be conducted through interviews with teachers and focus groups with students. They will be asked how they felt about randomisation and what, if any, challenges they encountered with this progression criterion.
Participant recruitment and retention
时间窗: baseline, 3 and 6 month follow up
Quantitative descriptive data, count number of participants at baseline, 3 and 6 month follow up
Suitability of data collection tools-Quantitative
时间窗: Quantitative missing data, after 6 months Follow up
Quantitative descriptive data, i.e. missing data
Suitability of data collection tools-qualitative perspectives
时间窗: Qualitative data collection phase- month 20-23
qualitative interviews and perspectives of participants on questionnaires, i.e. what did they think of the measures, length etc
Acceptability of the intervention
时间窗: Qualitative data collection phase, study month 20-23
qualitative exploration through focus groupd and interveiws-Was the intervention and its implementation acceptable to participants and stakeholders, including intervention components and delivery mode?
Feasibility of recruiting schools
时间窗: Start intervention delivery - study month 6-
Project monitoring data (descriptive data on number of schools and time of recruitment)
Feasibility of follow-up
时间窗: After 6 months Follow up
Descriptive quantitaive data-What proportion of participants could be followed up at 3 and 6 months?
Feasibility consent procedures
时间窗: Qualitative data collection phase month 20-23
Were consent procedures acceptable to participants? qualitative exploration through interviews and focus groups asking participants how they felt about consent procedures
次要结局
- Mental wellbeing scale(Baseline, 3-months, 6-months)
- Resilience scale(Baseline, 3-months, 6-months)
- Help-seeking attitudes scale(Baseline, 3-months, 6-months)
研究者
Floor Christie-de Jong
Associate Professor in Public Health for Medicine
University of Sunderland