Mental WellbeingNCT06807931
Impact of an Interactive Film on Resilience, Wellbeing, and Help-Seeking in School-Aged Youth
A study testing Interactive film in people with Mental Wellbeing and Resilience, run by University of Sunderland at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Wellbeing, Resilience, Help-Seeking Behaviour
- What is being tested?
- Interactive film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2021to 29 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- In selected Y10 or Y12 class (at start of study) at participating school
Who cannot join
- Lack of parental consent for Y10 students
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Sunderland
Sunderland, Sunderland, SR1 3SD
About this study
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
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.
Read the 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.
- Conditions
- Mental Wellbeing, Resilience, Help-Seeking Behaviour
- Being tested
- Interactive film
- Keywords
- Interactive film, Young people, School setting, Feasibility, Feasibility trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive filmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interactive film |
| 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. Receives: Other: Interactive film |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline, 3 and 6 month follow up
Suitability of data collection tools-Quantitative
Quantitative descriptive data, i.e. missing data
Measured: 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
Measured: 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?
Measured: 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)
Measured: 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?
Measured: 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
Measured: Qualitative data collection phase month 20-23
Secondary outcomes (3)
Mental wellbeing scale
Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS), validated questionnaire. Scores raneg from 14-70 with higher scores indicating greater positive wellbeing
Measured: 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
Measured: 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.
Measured: Baseline, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start14 Jun 2021
- Primary completion20 Mar 2023
- Study completion29 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sunderland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Huddersfield, University of Cumbria, Newcastle University, North East and North Cumbria Child Health and Wellbeing Network
- Responsible party
- Principal investigator, Floor Christie-de Jong, University of Sunderland
- Investigators
- Floor Christie-de Jong, Principal investigator, University of Sunderland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807931
- Sponsor's protocol ID
- 100471
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data can be shared upon reasonable request to the PI
Publications
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.
PubMed 40898276
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06807931
- Acronym / sponsor ID
- 100471
- Conditions
- Mental Wellbeing, Resilience, Help-Seeking Behaviour
- Keywords
- Interactive film, Young people, School setting, Feasibility, Feasibility trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of SunderlandUniversity, hospital or other
- Collaborators
- University of Huddersfield, University of Cumbria, Newcastle University, North East and North Cumbria Child Health and Wellbeing Network
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 29 Apr 2023 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Interactive filmParticipants 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. |
| Interactive Film Plus Support | Experimental | Other: Interactive filmParticipants 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- In selected Y10 or Y12 class (at start of study) at participating school
Key exclusion criteria (1 listed)
- Lack of parental consent for Y10 students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive filmAn 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. | Other | Interactive Film, Interactive Film Plus Support |
Primary outcome
Willingness of schools to participate and be randomised
Time frame: 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
Time frame: 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
Time frame: Quantitative missing data, after 6 months Follow up
Quantitative descriptive data, i.e. missing data
Suitability of data collection tools-qualitative perspectives
Time frame: 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
Time frame: 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
Time frame: Start intervention delivery - study month 6-
Project monitoring data (descriptive data on number of schools and time of recruitment)
Feasibility of follow-up
Time frame: After 6 months Follow up
Descriptive quantitaive data-What proportion of participants could be followed up at 3 and 6 months?
Feasibility consent procedures
Time frame: 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
3 secondary outcomes
Mental wellbeing scale
Time frame: Baseline, 3-months, 6-months
Resilience scale
Time frame: Baseline, 3-months, 6-months
Help-seeking attitudes scale
Time frame: Baseline, 3-months, 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Derived from this study: PubMed 40898276Christie-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.
- Individual participant dataSharing planned: No. Anonymised data can be shared upon reasonable request to the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Floor Christie-de Jong principal investigator
University of Sunderland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive film in people with Mental Wellbeing and Resilience, run by University of Sunderland at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness of schools to participate and be randomised (time frame: Qualitative data collection phase, month 20-23). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06807931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.