Home Goals: A study looking at improving mental and physical health and well-being in young people using short physical activity and psychological education sessions

ISRCTN ISRCTN16814810
DOI https://doi.org/10.1186/ISRCTN16814810
Secondary identifying numbers HG01 RDaSH 0243
Submission date
24/06/2021
Registration date
14/07/2021
Last edited
07/03/2025
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

Plain English summary of protocol

Background and study aims
Mental health problems are common in adolescents. For the treatment of depressive symptoms, existing literature reports the benefits of psychoeducation-based interventions.
The WHO (2018) recommends that young people engage in at least one hour of moderate physical activity a day. Vigorous physical activity has been shown to be a protective factor against mental health problems in adolescents. Physical activity has a huge potential to enhance our wellbeing. Even a short burst of 10 minutes’ brisk walking increases our mental alertness, energy and positive mood.
The combination of physical activity and psychoeducation in treatment of stress and depressive symptoms has shown to be superior than merely exercise alone.
The project aims to create therapy groups for children to improve their mental and emotional wellbeing. Each therapy group runs for one hour after school for six weeks, one half an hour focussing on physical activity (led by a local sports club) and another half an hour focusing on psychoeducation, led by NHS staff (e.g mental health nurse, psychiatrist, psychologist, Psychological Well-being Practitioners). The physical health aspect of the groups encompasses a broad range of physical activities, adapted to try at home. The groups also enable young people to learn about how and why anxiety and depression occur, and how we can learn ways of managing them.
This project is especially crucial given the nature of the COVID-19 pandemic, and ensuring the safety of staff and patients, by allowing the delivery of the interventions over video-conferencing software.

Who can participate?
School children aged 11-18 years who attend a participating school who are at risk of or are suffering from low-level mental health problems.

What does the study involve?
Participants will take part in one of the two 6-week interventions, depending on their group assignment. The intervention is the same for both groups but undertaken at different time points. Each therapy group runs for one hour after school for 6 weeks, one half an hour focussing on physical activity (led by a local sports club) and another half an hour focusing on psychoeducation, led by NHS staff (e.g., mental health nurse, psychiatrist, psychologist, psychological well-being practitioners). The physical health aspect of the groups encompasses a broad range of physical activities, adapted to try at home. The groups also enable young people to learn about how and why anxiety and depression occur, and how we can learn ways of managing them. This project is especially crucial given the nature of the COVID-19 pandemic, and ensuring the safety of staff and patients, by allowing the delivery of the interventions over video-conferencing software.

What are the possible benefits and risks of participating?
Participants should increase their understanding of negative emotions and why we experience them, and that it is normal to do so. They will then be given tools to help them deal with the negative impact of these emotions. They will be given the opportunity to try out new physical activities which also provides benefits to their physical and mental health. This may also encourage them to continue with physical activity, leading to long-term benefits Some participants may experience unexpected discomfort during the physical exercise, at which point they will be encouraged to stop. They can withdraw from the study at any time. There is a small chance that children may become distressed during the psychoeducation section, at which time they can leave the session, and they will be signposted on to services that can help them using a support services leaflet. There will be two presents during the session, so if necessary one presenter can speak privately to the distressed participant. Confidentiality will be broken if the participant discloses self-harm or suicidal ideation.

Where is the study run from?
Rotherham Doncaster and South Humber NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2020 to January 2023

Who is funding the study?
1. Active Humber (UK)
2. Yorkshire Sport Foundation (UK)

Who is the main contact?
Dr Victoria Laker
rdash.groundedresearch@nhs.net

Contact information

Dr Victoria Laker
Scientific

Research Governance Manager
Grounded Research Hub
Rotherham Doncaster and South Humber NHS Foundation Trust
2 St Catherines Close
Tickhill Road Hospital
Balby
Doncaster
DN4 8QN
United Kingdom

Phone +44 (0)1302 798456
Email victoria.laker@nhs.net

Study information

Study designPragmatic stepped-wedge open-label randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet ISRCTN16814810_PIS_Parents_v2.1_23Apr2021.pdf
Scientific titleHome Goals: a randomised controlled trial to improve mental and physical health and well-being in young people
Study acronymHome Goals
Study objectives1. Exposure to the intervention will be associated with a significantly lower mean score of depression and anxiety by comparison to a waitlist (delayed intervention) control group
2. After the control group is exposed to the intervention, there will be no significant differences in mean depression and anxiety level between the two groups (immediate intervention group, delayed intervention group)
3. Mean depression and anxiety severity for all participants at the end of the 6-month follow-up period will be significantly lower than baseline severity (prior to intervention), but not significantly different to end-of-treatment severity, indicating maintenance of gains
4. Attitude towards physical exercise will significantly improve following the intervention, and be maintained at the 6-month follow-up period
Ethics approval(s)Approved 27/05/2021, South West - Frenchay Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, UK; frenchay.rec@hra.nhs.uk), REC ref: 21/SW/0046
Health condition(s) or problem(s) studiedMental health
InterventionConsenting participants will be randomly assigned to two groups by a research assistant using a computerized randomization algorithm (applying a simple 1:1 randomization schedule). Participants will take part in one of the two 6-week interventions, depending on their group assignment.

The intervention is a 6-week, psychoeducation and physical education course consisting of online live psychoeducation sessions and physical activity sessions. The intervention is the same for both groups but undertaken at different time points. The interventions will be delivered using an online approach; weekly online video-conference sessions involving half an hour of psychoeducation and half an hour of physical activity. Both interventions will involve a total of six 1-hour sessions delivered once per week using video-conferencing software that can involve large groups of participants. The study will be carried out in four phases.

Participants will complete an online survey with standardised measures at baseline (prior to starting the interventions), after 6 weeks (after group 1 has finished and prior to group 2 commencing), after 12 weeks (post-treatment) and finally after 6 months (follow-up). All measures will be completed online using an industry-standard survey system that automatically sends email reminders to consenting participants.
Intervention typeBehavioural
Primary outcome measureDepression is measured using the Patient Health Questionnaire-adapted for Adolescents (PHQ-A) at baseline, six weeks, 12 weeks and six months after completion of the interventions
Secondary outcome measures1. Demographic information, including age, gender, ethnicity measured by self-report
2. Anxiety is measured using the Generalized Anxiety Disorder-adapted for Adolescents (GAD-A) at baseline, six weeks, 12 weeks and six months after completion of the interventions
3. Physical activity is measured using the physical activity section of the Health Behaviour in School-Aged Children (HBSC) at baseline, six weeks, 12 weeks and six months after completion of the interventions
Overall study start date01/09/2020
Completion date23/01/2023

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit11 Years
Upper age limit17 Years
SexBoth
Target number of participants192
Total final enrolment57
Key inclusion criteria1. Any child aged 11-17 years (the researchers will accept participants who turn 18 in the trial period) who may benefit
2. Children must attend a school within the Rotherham, Doncaster, North Lincolnshire or Bradford locality
Key exclusion criteria1. Adolescents who are already in receipt of psychological therapy
2. Adolescents with a diagnosed condition (such as autism spectrum disorder, learning disabilities, severe depression)
3. Adolescents experiencing suicidal ideation
4. Adolescents with no access to electronic devices
5. Anyone who has participated in either Home Goals or Safety Nets before
6. Anyone who is 18 years old at the time of recruiting (the researchers will accept if they turn 18 over the trial period – but not before the trial starts)
Date of first enrolment08/06/2021
Date of final enrolment31/03/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Grounded Research
Rotherham Doncaster and South Humber NHS Foundation Trust
2 St. Catherine's Close
Tickhill Rd Site
Balby
Doncaster
DN4 8QP
United Kingdom
Bradford District Care NHS Foundation Trust
New Mill
Victoria Rd
Saltaire
Shipley
Bradford
BD18 3LD
United Kingdom

Sponsor information

Rotherham Doncaster and South Humber NHS Foundation Trust
Hospital/treatment centre

Grounded Research
St Catherine’s Close
Tickhill Road Hospital
Balby
Doncaster
DN4 8QP
England
United Kingdom

Phone +44 (0)1302 789456
Email rdash.groundedresearch@nhs.net
Website https://www.rdash.nhs.uk/

Funders

Funder type

Charity

Active Humber

No information available

Yorkshire Sport Foundation

No information available

Results and Publications

Intention to publish date31/12/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planAfter the conclusion of data analysis, we plan to disseminate findings about this study using a variety of forms of communication, including:
1. Scientific journal publications
2. Newsletter in lay terminology
3. NHS Trust communications newsletter and email
4. NHS Trust conferences, strategic meetings
5. Mental health conferences in the UK and abroad
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request - victoria.laker@nhs.net. We do not wish to make the dataset readily available due to the age of the participants. The dataset will be held in a restricted-access drive. The study dataset will be held at the University for a minimum of 5 years after the conclusion of the study.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version v2.1 23/04/2021 14/07/2021 No Yes
Participant information sheet version v1.1 23/04/2021 14/07/2021 No Yes
Protocol file version v2.1 23/04/2021 14/07/2021 No No
HRA research summary 28/06/2023 No No
Basic results 03/03/2025 No No
Statistical Analysis Plan 03/03/2025 No No
Dataset 07/03/2025 No No

Additional files

ISRCTN16814810_PROTOCOL_v2.1_23Apr2021.pdf
Uploaded 14/07/2021
ISRCTN16814810_PIS_Parents_v2.1_23Apr2021.pdf
Uploaded 14/07/2021
ISRCTN16814810_PIS_v1.1_Participants_16+_23Apr2021.doc.pdf
Uploaded 14/07/2021
ISRCTN16814810_BasicResults.pdf
ISRCTN16814810_Statistical_analysis_plan.pdf
ISRCTN16814810_Dataset.xlsx

Editorial Notes

07/03/2025: Dataset uploaded.
03/03/2025: Basic results and statistical analysis plan files uploaded.
14/05/2024: Total final enrolment added. The intention to publish date was changed from 30/11/2023 to 31/12/2025.
06/01/2023: The overall trial end date has been changed from 06/01/2023 to 23/01/2023.
24/11/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/08/2021 to 31/03/2022.
2. The overall trial end date was changed from 02/01/2023 to 06/01/2023.
3. The intention to publish date was changed from 02/01/2024 to 30/11/2023.
14/07/2021: Uploaded protocol Version 2.1, 23 April 2021 (not peer reviewed). The participant information sheet has been uploaded.
25/06/2021: Trial's existence confirmed by NHS HRA.