NCT06807931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

January 17, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

Interactive filmYoung peopleSchool settingFeasibilityFeasibility trial

Outcome Measures

Primary Outcomes (8)

  • 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-

  • 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

Secondary Outcomes (3)

  • Mental wellbeing scale

    Baseline, 3-months, 6-months

  • Resilience scale

    Baseline, 3-months, 6-months

  • Help-seeking attitudes scale

    Baseline, 3-months, 6-months

Study Arms (3)

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.

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.

Other: Interactive film

Interventions

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.

Interactive FilmInteractive Film Plus Support

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Lack of parental consent for Y10 students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sunderland

Sunderland, Sunderland, SR1 3SD, United Kingdom

Location

Related Publications (1)

  • 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.

Study Officials

  • Floor Christie-de Jong

    University of Sunderland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Public Health for Medicine

Study Record Dates

First Submitted

January 17, 2025

First Posted

February 4, 2025

Study Start

June 14, 2021

Primary Completion

March 20, 2023

Study Completion

April 29, 2023

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Anonymised data can be shared upon reasonable request to the PI

Locations