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.
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. Randomisation Each of the three schools will be allocated at random (i.e. computer generated stratified randomisation), to one of the three intervention conditions: control condition, interactive film and interactive film plus support, matched according to the size of the school, socio-economic level, estimated by proportion of students receiving free school meals, and urban or rural location. Participants Participants will be aged 14-18, years 10-12, at participating schools. Years 11 and 13 will not be targeted because of exam preparation, particularly in the light of COVID-19 disruption. Participants who receive parental consent as appropriate and who provide written informed consent/assent to taking part will be invited to complete baseline measures. Study Intervention Interactive film Follow-up Participants will be followed up at 3-months and 6-months. Qualitative evaluation After the intervention participants will be invited to take part in a focus group (n=6, per school). Focus groups tend to be more comfortable for young people (29). The invitation will be on a separate form accompanying their survey documents. If participants are interested they will provide their contact details, which will be retained separately from the research data. The focus groups will explore young people's views on the trial procedures and the intervention. Interviews (n=6) will be conducted with head teachers and youth workers on acceptability of the trial and intervention. Analysis Descriptive statistics will be used to provide estimations regarding recruitment, retention, intervention delivery and inform power-calculations for a large-scale trial. Descriptive statistics will be used to report participants' scores on scales. Two-way ANOVA will be used for preliminary analysis to explore differences between groups, however instead of doing a formal hypothesis testing to prove effectiveness, a 95 % confidence interval will be presented to describe the range of effect. Thematic content analysis will be used to capture recurring themes, commonalities and patterns in people's perspectives explored in focus groups and interviews.
An interactive film, co-produced with young people, that aims to provide young people with a virtual experience of making choices and facing consequences in various life scenarios. At key moments the action is paused and the user decides the outcome. The particular film series that was commissioned and included in the trial was 'Jessica's story', which focused on perinatal mental health, as well as many other public health issues relevant to young people, including mental wellbeing, domestic violence, and help-seeking behaviour.
University of Sunderland
Sunderland, Sunderland, United Kingdom
Willingness of schools to participate and be randomised
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.
Time frame: Qualitative data collection phase, month 20-23
Participant recruitment and retention
Quantitative descriptive data, count number of participants at baseline, 3 and 6 month follow up
Time frame: baseline, 3 and 6 month follow up
Suitability of data collection tools-Quantitative
Quantitative descriptive data, i.e. missing data
Time frame: Quantitative missing data, after 6 months Follow up
Suitability of data collection tools-qualitative perspectives
qualitative interviews and perspectives of participants on questionnaires, i.e. what did they think of the measures, length etc
Time frame: Qualitative data collection phase- month 20-23
Acceptability of the intervention
qualitative exploration through focus groupd and interveiws-Was the intervention and its implementation acceptable to participants and stakeholders, including intervention components and delivery mode?
Time frame: Qualitative data collection phase, study month 20-23
Feasibility of recruiting schools
Project monitoring data (descriptive data on number of schools and time of recruitment)
Time frame: Start intervention delivery - study month 6-
Feasibility of follow-up
Descriptive quantitaive data-What proportion of participants could be followed up at 3 and 6 months?
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
175
Time frame: After 6 months Follow up
Feasibility consent procedures
Were consent procedures acceptable to participants? qualitative exploration through interviews and focus groups asking participants how they felt about consent procedures
Time frame: Qualitative data collection phase month 20-23
Mental wellbeing scale
Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS), validated questionnaire. Scores raneg from 14-70 with higher scores indicating greater positive wellbeing
Time frame: Baseline, 3-months, 6-months
Resilience scale
Connor-Davidson Resilience Scale for young adults (10 items), validated questionnaire. Total scores range from 0-40, with higher scores indicating greater resilience
Time frame: Baseline, 3-months, 6-months
Help-seeking attitudes scale
The 10-item Attitudes Toward Seeking Professional Psychiatric Help Scale (ATSPPHS) tool, validated questionnaire Total range scores: 0-30, above 20 Reflect a positive attitude toward seeking professional psychological help. Below 10 Reflect a negative attitude or reluctance toward seeking professional psychological help. Mid range (10-20 Reflect ambivalence or mixed attitudes.
Time frame: Baseline, 3-months, 6-months