Digital support for young people with their mood and wellbeing
| ISRCTN | ISRCTN12437531 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12437531 |
| IRAS number | 257222 |
| Secondary identifying numbers | IRAS 257222, CPMS 49679 |
- Submission date
- 23/03/2022
- Registration date
- 29/04/2022
- Last edited
- 21/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Depression is common in young people, and most are not getting any help. Researchers have developed a digital programme, MoodHwb, with young people and families/carers to support their mood and well-being. The programme is a website and an app. It aims to engage and promote self-help, help-seeking, and social support. The study aims to further develop and test MoodHwb by looking at how young people use it and by getting feedback from young people, parents/carers and professionals who use it. If found to be effective, the programme could be made freely available and rolled out in health, education, youth and social services/charities.
Who can participate?
Adolescents aged 13 to 19 years old who have problems with their mood and wellbeing (e.g. feeling down or low in mood), their parents and carers, and professionals who work with young people.
What does the study involve?
Young people interested in the study will be asked to fill out a form on the study website. If eligible, they will be asked to complete consent forms and then questionnaires about their mood and wellbeing. Two-thirds of young people will have access to the online programme and a third will receive a digital information pack. A computer will decide which group they will go into. The young people with access to the programme will be able to use it as much they like, either on their own or with someone else. Two months later all participants will be asked to complete questionnaires again. Some of the young people and parents/carers who had access to the programme will be interviewed for their feedback on it. There will also be a group meeting for professionals to discuss the programme.
What are the possible benefits and risks of participating?
Participants may find it useful and interesting to take part in the study. Some might find it difficult to think about mental health problems when taking part in the project, and the researchers will try to avoid this as much as possible. They will arrange for meetings to be as convenient and comfortable as possible. The meetings will be focused on the programme, and not on the participants' personal experiences of mental health difficulties. If after taking part they feel the need for support, they can get in touch with the researchers at any time. The researchers will discuss the problems with them and whether they need to talk to someone else, such as their family doctor.
Where is the study run from?
Cardiff University (UK)
When is the study starting and how long is it expected to run for?
November 2018 to January 2024
Who is funding the study?
1. National Institute for Health Research (UK)
2. Health and Care Research Wales (UK)
Who is the main contact?
Dr Rhys Bevan Jones
bevanjonesr1@cardiff.ac.uk, YouthOnlineStudy@cardiff.ac.uk.
Contact information
Principal Investigator
Division of Psychological Medicine & Clinical Neurosciences
Cardiff University
Hadyn Ellis Building
Maindy Rd
Cardiff
CF24 4HQ
United Kingdom
 ORCID ID |
0000-0001-8976-9825 |
|---|---|
| Phone | +44 (0)2920688451 |
| bevanjonesr1@cardiff.ac.uk |
Study information
| Study design | Feasibility randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Further development and feasibility trial of a digital programme for adolescent depression (MoodHwb) |
| Study hypothesis | The digital programme to support mood and well-being in young people, MoodHwb, and the trial methods are feasible and acceptable. |
| Ethics approval(s) | Approved 01/09/2021, Wales REC 3 (Health and Care Research Support Center, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920785735; Wales.REC3@wales.nhs.uk), ref: 21/WA/0205 |
| Condition | Adolescent depression |
| Intervention | Participants will be assigned randomly 2:1 to use the digital programme, MoodHwb, or digital health information sheets (all will also continue with their usual treatment). The randomisation will be computerised and stratified related to site (Wales/Scotland sites). Two-thirds of the participants will be from Wales and one-third from Scotland. The young people (and their families/carers) will complete questionnaires about their mood and behaviour at the start of the study and again after 2 months. Some will also be interviewed and there will be a focus group for professionals to discuss the programme and study. |
| Intervention type | Other |
| Primary outcome measure | 1. Feasibility and acceptability outcomes related to the digital programme, including: 1.1. Level of usage of programme, from Web usage, questionnaire and interview data, after 2 months 1.2. Views/acceptability of design and content of programme, from interview and focus group data, after 2 months 1.3. Technical and accessibility aspects, from Web usage, questionnaire and interview data, after 2 months 2. Feasibility and acceptability outcomes related to the trial methods, including: 2.1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 6 months - updated 29/03/2023: 9 months 2.2. Retention rate assessed using the number of participants who consent to participate who remain in the study at 2 months 2.3. Completeness of outcome measure questionnaire data at baseline and 2 months 2.4. Views/acceptability of the methods, particularly the remote approaches, from questionnaire data at baseline and 2 months, and interview data at 2 months |
| Secondary outcome measures | Core set of domains at baseline and 2-month follow-up including: 1. Depression literacy/knowledge measured using the Adolescent Depression Knowledge Questionnaire 2. Stigma measured using the Depression Stigma Scale 3. Self-efficacy measured using the General Self-Efficacy Scale 4. Help-seeking behaviour measured using the General Health-Seeking Questionnaire 5. Wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale 6. Depressive and anxiety symptoms measured using the Mood and Feelings Questionnaire; Revised Children’s Anxiety and Depression Scale-short version |
| Overall study start date | 01/11/2018 |
| Overall study end date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 13 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 120 young people and their parents/guardians |
| Participant inclusion criteria | Current inclusion criteria as of 29/03/2023: 1. Adolescents aged 13-19 years 2. Experiencing depressive symptoms 3. Sufficient understanding of English 4. Access to the Internet and a valid email address Previous inclusion criteria: 1. Adolescents aged 13-19 years 2. Experiencing depressive symptoms, where this is the primary mental health difficulty 3. Sufficient understanding of English 4. Access to the Internet and a valid email address |
| Participant exclusion criteria | Current exclusion criteria as of 29/03/2023: 1. Young people already receiving specialist treatment for depression (e.g. cognitive behavioural therapy (CBT) in secondary child and adolescent mental health services [CAMHS]) 2. Presence of other mental health difficulties, where alternative support might be appropriate Previous exclusion criteria: 1. Young people already receiving specialist treatment for depression (e.g. cognitive behavioural therapy (CBT) in secondary child and adolescent mental health services [CAMHS]) 2. Presence of severe depressive symptoms 3. Presence of other severe mental health difficulties |
| Recruitment start date | 14/11/2022 |
| Recruitment end date | 30/11/2023 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
- Wales
Study participating centres
Cardiff
CF10 3AT
United Kingdom
Glasgow
G12 8QQ
United Kingdom
Sponsor information
University/education
Research and Innovation Services
7th Floor
McKenzie House
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Phone | +44 (0)2920879273 |
|---|---|
| resgov@cardiff.ac.uk | |
| Website | https://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health & Care Research Wales, Ymchwil Iechyd a Gofal Cymru, Health Care Research Wales, HCRW
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of protocol and trial findings in high-impact peer-reviewed journals |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the PI at YouthOnlineStudy@cf.ac.uk, subject to review according to internal processes and appropriate data sharing agreements, at the Centre for Trials Research, Cardiff University and the University of Glasgow. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 21/11/2022 | 29/03/2023 | No | No | |
| Protocol article | 05/06/2023 | 06/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/12/2023: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2023 to 30/11/2023.
2. The overall study end date has been changed from 31/12/2023 to 31/01/2024 and the plain English summary updated accordingly.
14/08/2023: The following changes have been made:
1. The recruitment end date has been changed from 13/08/2023 to 31/10/2023.
2. The overall study end date has been changed from 13/10/2023 to 31/12/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/06/2024 to 30/09/2024.
06/06/2023: Publication reference added.
11/04/2023: IPD sharing statement added.
29/03/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 12/04/2022 to 14/11/2022.
2. The recruitment end date was changed from 12/10/2022 to 13/08/2023.
3. The overall trial end date was changed from 31/10/2022 to 13/10/2023.
4. The intention to publish date was changed from 31/10/2023 to 30/06/2024.
5. The primary outcome measures and the inclusion and exclusion criteria were updated.
6. Preprint added.
05/05/2022: Internal review.
28/03/2022: Trial's existence confirmed by the HRA.
