An intervention to support skills for managing emotions for 9-11 year olds in Welsh schools

ISRCTN ISRCTN91291368
DOI https://doi.org/10.1186/ISRCTN91291368
Submission date
26/11/2024
Registration date
11/12/2024
Last edited
18/08/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study aims to see if a group for young people could be helpful for those who are experiencing problems such as sadness, anxiety or stress. The group is called EASE (Early Adolescent Skills for Emotions). It will look at how to assess which young people will find the group helpful, and the best way to set up a group in a Welsh school.

Who can participate?
Participants are 9-11 year olds from Welsh schools who have experienced some kind of adversity and who are struggling with worries or sadness.

What does the study involve?
The children will attend seven weekly sessions aimed at building skills for emotions. Their parents/caregivers will also attend three complementary sessions. Participants will answer wellbeing questions and some will be interviewed after the intervention about their experience.

What are the possible benefits and risks of participating?
Participants should benefit from the intervention as it can support their wellbeing. There is a small risk of distress as sometimes when people talk about difficult times they might get upset.

Where is the study run from?
The National Centre for Population Health and Wellbeing, Swansea University

When is the study starting and how long is it expected to run for?
June 2024 to April 2025. The intervention will take place from January to February 2025.

Who is funding the study?
Public Health Wales and the Economic and Social Research Council through their support of a PhD studentship

Who is the main contact?
Flo Avery, 2226345@swansea.ac.u
Prof Sinead Brophy, s.brophy@swansea.ac.uk, is the supervisor and Director of the National Centre for Population Health and Wellbeing at Swansea University.

Contact information

Prof Sinead Brophy
Scientific

Singleton Park
Swansea
SA2 8PP
United Kingdom

Phone +44 (0)7864836943
Email s.brophy@swansea.ac.uk
Ms Flo Avery
Public, Principal Investigator

Singleton Park
Swansea
SA2 8PP
United Kingdom

Phone 07925967634
Email f.l.avery.2226345@swansea.ac.uk

Study information

Study designPilot feasibility trial across two school sites
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Medical and other records, School
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleThe implementation of a manualised group intervention for youth with adverse childhood experiences offered through schools in Wales: a feasibility study protocol
Study objectivesThe EASE intervention is an evidence-based intervention suitable for delivery by non-clinicians, which reduces internalising distress in adolescents. EASE has never been trialled in Wales. This study will look at whether EASE can be effective for Welsh adolescents.
Ethics approval(s)

Approved 27/09/2024, Swansea University Health and Social Care Ethics Committee (Singleton Park, Swansea, SA2 8PP, United Kingdom; +441792606996; FMHLS-Ethics@swansea.ac.uk), ref: 4 2024 10283 10467

Health condition(s) or problem(s) studiedAlleviation of internalising distress symptoms
InterventionThis study will involve a mixed methods design using quantitative and qualitative methods to assess the EASE group intervention in a Welsh context. There is no control group. Two school sites both access the EASE (Early Adolescent Skills for Emotions) intervention. This is a group intervention which has 7 weekly sessions for adolescents and 3 complementary sessions for their caregivers/parents. The intervention will be delivered on the school site.
Intervention typeBehavioural
Primary outcome measureAcceptability and feasibility measured via consent and assent rates, and session and programme completion rates using data collected in the study records at one timepoint
Secondary outcome measuresAcceptability of the assessment measures will be measured via completion rates using data collected in the study records at one timepoint. Participants (young people and caregivers) and school staff will also be asked to take part in qualitative, semi-structured exit interviews following intervention delivery.
Overall study start date01/06/2024
Completion date11/04/2025

Eligibility

Participant type(s)Learner/student, Other
Age groupMixed
Lower age limit9 Years
Upper age limit12 Years
SexBoth
Target number of participants48
Total final enrolment34
Key inclusion criteria1. Young people aged 9.5-12 years enrolled at a participating school, and their caregivers
2. Caregiver has given consent and the young person has given their assent
3. Young person has experienced at least one Adverse Childhood Experience (ACE)
4. Young person is struggling with internalising distress such as sadness or worry
Key exclusion criteria1. Young people who are self-harming or at imminent risk of suicide
2. Young people with significant challenges such as psychosis or alcohol dependency
3. Young people who are currently on a child protection plan (e.g. subject to safeguarding proceedings)
4. Young people who are currently accessing another therapeutic intervention such as school-based counselling
Date of first enrolment30/09/2024
Date of final enrolment15/01/2025

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

School information cannot be shared as it may violate anonymity of participants
Caerphilly Borough
Caerphilly Borough
N/A
United Kingdom

Sponsor information

Swansea University
University/education

Singleton Park
Swansea
SA2 8PP
Wales
United Kingdom

Email resgov@swansea.ac.uk
Website https://www.swansea.ac.uk/
ROR logo "ROR" https://ror.org/053fq8t95

Funders

Funder type

Government

Economic and Social Research Council
Government organisation / National government
Alternative name(s)
ESRC
Location
United Kingdom
Public Health Wales
Government organisation / Local government
Alternative name(s)
Iechyd Cyhoeddus Cymru, Public Health Wales NHS Trust, PHW
Location
United Kingdom

Results and Publications

Intention to publish date01/08/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer reviewed journal.
Findings will also be expressed in an accessible manner and disseminated to a wider audience including schools in Wales through the HAPPEN network, and to Educational Psychology Services in Welsh local authorities.
IPD sharing planThe dataset will be available upon request from Flo Avery (2226345@swansea.ac.uk)

Editorial Notes

18/08/2025: The completion date was changed from 01/08/2025 to 11/04/2025.
27/01/2025: Total final enrolment added.
27/11/2024: Study's existence confirmed by the Swansea University Health and Social Care Ethics Committee.