Impact of an Interactive Film on Resilience, Wellbeing, and Help-Seeking in School-Aged Youth

Not Applicable

Completed

• Conditions: Mental Wellbeing; Resilience; Help-Seeking Behaviour

• Registration Number: NCT06807931
• Lead Sponsor: University of Sunderland

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-06-14
• Primary Completion: 2023-03-20
• Study Completion: 2023-04-29
• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• In selected Y10 or Y12 class (at start of study) at participating school

Exclusion Criteria

• Lack of parental consent for Y10 students

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Willingness of schools to participate and be randomised	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	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	Quantitative missing data, after 6 months Follow up	Quantitative descriptive data, i.e. missing data
Suitability of data collection tools-qualitative perspectives	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	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	Start intervention delivery - study month 6-	Project monitoring data (descriptive data on number of schools and time of recruitment)
Feasibility of follow-up	After 6 months Follow up	Descriptive quantitaive data-What proportion of participants could be followed up at 3 and 6 months?
Feasibility consent procedures	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

Secondary Outcome Measures

Name	Time	Method
Mental wellbeing scale	Baseline, 3-months, 6-months	Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS), validated questionnaire. Scores raneg from 14-70 with higher scores indicating greater positive wellbeing
Resilience scale	Baseline, 3-months, 6-months	Connor-Davidson Resilience Scale for young adults (10 items), validated questionnaire. Total scores range from 0-40, with higher scores indicating greater resilience
Help-seeking attitudes scale	Baseline, 3-months, 6-months	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.

Trial Locations

Locations (1)

University of Sunderland; 🇬🇧 Sunderland, United Kingdom