Clinical trial NCT06807931: Impact of an Interactive Film on Resilience, Wellbeing, and Help-Seeking in School-Aged Youth
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Wellbeing
Resilience
Help-Seeking Behaviour
Keywords: Interactive film
Young people
School setting
Feasibility
Feasibility trial
Lead sponsor: University of Sunderland
Sponsor class: OTHER
Collaborators: name: University of Huddersfield
name: University of Cumbria
name: Newcastle University
name: North East and North Cumbria Child Health and Wellbeing Network
First posted: 2025-02-04
Enrollment: 175
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Lack of parental consent for Y10 students

Primary outcomes:
measure: Willingness of schools to participate and be randomised
timeFrame: Qualitative data collection phase, month 20-23
measure: Participant recruitment and retention
timeFrame: baseline, 3 and 6 month follow up
measure: Suitability of data collection tools-Quantitative
timeFrame: Quantitative missing data, after 6 months Follow up
measure: Suitability of data collection tools-qualitative perspectives
timeFrame: Qualitative data collection phase- month 20-23
measure: Acceptability of the intervention
timeFrame: Qualitative data collection phase, study month 20-23
measure: Feasibility of recruiting schools
timeFrame: Start intervention delivery - study month 6-
measure: Feasibility of follow-up
timeFrame: After 6 months Follow up
measure: Feasibility consent procedures
timeFrame: Qualitative data collection phase month 20-23
Secondary outcomes:
measure: Mental wellbeing scale
timeFrame: Baseline, 3-months, 6-months
measure: Resilience scale
timeFrame: Baseline, 3-months, 6-months
measure: Help-seeking attitudes scale
timeFrame: Baseline, 3-months, 6-months
Other outcomes:
Locations:
city: Sunderland
country: United Kingdom
facility: University of Sunderland
Study officials:
affiliation: University of Sunderland
name: Floor Christie-de Jong
role: PRINCIPAL_INVESTIGATOR
References: