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| Name | Class |
|---|---|
| University of Huddersfield | OTHER |
| University of Cumbria | UNKNOWN |
| Newcastle University | OTHER |
| North East and North Cumbria Child Health and Wellbeing Network |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control condition | No Intervention | Participants in this condition received the standard Personal, Social, Health, and Economic (PSHE) Education curriculum provided by the school. | |
| Interactive Film | Experimental | Participants in this condition engaged in three class sessions wherein they watched the interactive film. The film was delivered both individually and to the whole class and featured decision points, and the viewer's choices influenced the storyline's progression. |
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| Interactive Film Plus Support | Experimental | Participants in this condition watched the interactive film as in the previous condition. Additionally, they participated in facilitated discussions led by trained youth workers, focusing on the decisions made in the film and their consequences. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive film | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | baseline, 3 and 6 month follow up |
| Suitability of data collection tools-Quantitative | Quantitative descriptive data, i.e. missing data | 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 | 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? | 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) | Start intervention delivery - study month 6- |
| Measure | Description | Time Frame |
|---|---|---|
| Mental wellbeing scale | Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS), validated questionnaire. Scores raneg from 14-70 with higher scores indicating greater positive wellbeing | Baseline, 3-months, 6-months |
| Resilience scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Floor Christie-de Jong | University of Sunderland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sunderland | Sunderland | Sunderland | SR1 3SD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40898276 | Derived | Christie-de Jong F, Walker E, Corlett H, Hardarce C, Soulsby E, Arnott B, Franks K, Ling J, Stephenson J, Azevedo LB. A cluster randomised feasibility trial assessing an interactive film intervention to improve wellbeing of young people in school settings in the North of England. Pilot Feasibility Stud. 2025 Sep 2;11(1):117. doi: 10.1186/s40814-025-01699-1. |
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Anonymised data can be shared upon reasonable request to the PI
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| UNKNOWN |
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| Feasibility of follow-up | Descriptive quantitaive data-What proportion of participants could be followed up at 3 and 6 months? | 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 | Qualitative data collection phase month 20-23 |
Connor-Davidson Resilience Scale for young adults (10 items), validated questionnaire. Total scores range from 0-40, with higher scores indicating greater resilience
| 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. | Baseline, 3-months, 6-months |