Skills for adolescent wellbeing
| ISRCTN | ISRCTN13924193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13924193 |
| IRAS number | 305331 |
| Secondary identifying numbers | IRAS 305331, SPON1902-22, CPMS 54480 |
- Submission date
- 14/03/2023
- Registration date
- 15/03/2023
- Last edited
- 25/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Depression is common in young people. It is impairing and can have a long-term impact. Finding ways to prevent depression from developing in young people is important. Studies have found that a type of talking therapy - Cognitive Behavioural Therapy (CBT) - which involves learning skills like how to solve problems and how to think in a balanced, less negative way, can help to reduce depression in young people. This type of talking therapy may work particularly well for young people who have a higher-than-average chance of developing depression (e.g. for young people whose parent(s) have a history of depression, those who have experienced depression before themselves, or have mild depressive symptoms).
This study aims to test whether an online group CBT program helps to prevent depression in young people who are at increased risk of developing depression. It also aims to understand how the CBT program works, and what young people and their parents think of it. As there is evidence to suggest that the presence of depression in parents may reduce the effectiveness of CBT programs for depression in young people, this study will also involve optimizing the treatment of parents who are depressed at the start of the study.
Who can participate?
We are inviting young people aged 13-19 years old and their parents to take part. In order to take part we are asking that young people:
• have been diagnosed with depression before, OR currently have mild symptoms of depression (but are not depressed)
• live with a parent who has been diagnosed with depression recently or in the past, who is also willing to take part in the study
• have access to the internet and have a valid email address.
What does the study involve?
Parents and young people who are interested in taking part in the study will first complete screening questions with a researcher, including questions about depression symptoms, to check they are eligible to take part in the study.
For those that are eligible to take part, where the parent has high levels of depression symptoms at the screening stage, the parent will undergo a 12-week period of depression treatment optimization with a study psychiatrist. At the end of the treatment optimization, the parent and young person will be entered into the study. For those that are eligible to take part, where the parent does not have high levels of depression symptoms at the screening stage, the parent and young person will be entered straight into the study.
On entering the study, baseline assessments (questionnaires and interviews) will be completed with parent and young person. Following these assessments the young person will be allocated randomly to receive either i) a group psychological intervention designed for the prevention of adolescent depression plus treatment as usual (TAU), OR ii) treatment as usual (TAU).
Young people allocated to the psychological intervention group will join an online group of 6-8 young people plus a facilitator. The group will meet via video call, for up to 1.5 hours per week over 8 weeks, followed by 3 continuation sessions held monthly. During online group sessions young people will learn new skills by taking part in group Cognitive Behavioural Therapy (CBT). Young people in this psychological intervention group will also be free to continue any existing treatment and begin new treatments outside the study, alongside the trial intervention.
Young people allocated to the treatment as usual group (TAU) will not receive the group psychological intervention, but they will be able to continue with any treatment that they already receive and will be free to begin new treatment outside the study.
All parents and all young people participating will be asked to complete questionnaires and meet with researchers to answer questions over a 9-month follow-up period. In addition to this, some parents who took part in the parent depression treatment optimisation, and some of the young people who took part in the psychological intervention group will be asked to talk to researchers separately about their experience of taking part.
What are the possible benefits and risks of participating?
Possible benefits: Research participants will have the chance to increase understanding of depression, and the ways to prevent it from developing in young people. This might help to improve the care of other young people in the future.
Young people and parents involved in the study may also directly benefit from taking part. The young people who are allocated to the group therapy intervention will be taught problem solving skills, how to cope with stress and how to reduce unrealistic negative thinking, with the aim of preventing them from developing depression in the future. Parents who are depressed at the screening stage of the trial will undergo treatment optimisation, with the aim of reducing their depression symptoms.
Possible risks: Some people may find it difficult to discuss certain things such as their mood and how they are feeling. For those who feel they need support whilst taking part in the study, our study team will be available for them to talk to and discuss whether it would be helpful to talk to someone else, such as their family doctor.
Where is the study run from?
Wolfson Centre for Young People’s Mental Health at Cardiff University (UK)
When is the study starting and how long is it expected to run for?
March 2021 to December 2026
Who is funding the study?
The Wolfson Foundation (UK)
Who is the main contact?
Professor Frances Rice, Professor of Developmental Psychopathology, ricef2@cardiff.ac.uk
Contact information
Principal Investigator
Hadyn Ellis Building
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
 ORCID ID |
0000-0002-9484-1729 |
|---|---|
| Phone | +44 2920688384 |
| ricef2@cardiff.ac.uk |
Scientific
Hadyn Ellis Building
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
| ORCID ID |
0000-0003-1944-9679 |
|---|---|
| Phone | +44 2920688452 |
| eyreo2@cardiff.ac.uk |
Scientific
Hadyn Ellis Building
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
| Phone | +44 29 2068 8452 |
|---|---|
| powellv@cardiff.ac.uk |
Public
Centre for Trials Research
Cardiff University
Cardiff
CF14 4YS
United Kingdom
| ThomasR95@cardiff.ac.uk |
Scientific
Centre for Trials Research
Cardiff University
Cardiff
CF14 4YS
United Kingdom
| AirdrieJ@Cardiff.ac.uk |
Study information
| Study design | Randomized controlled effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial of a group Cognitive Behavioural Therapy intervention for young people with parental treatment optimisation: skills for adolescent WELLbeing (SWELL) |
| Study acronym | SWELL |
| Study hypothesis | Current study hypothesis as of 22/08/2024: The group CBT intervention evaluated in this trial will increase the time to depressive disorder in young people aged 13-19 years who are at increased risk for developing depression compared to treatment as usual. The group CBT intervention will reduce symptoms of mental health problems, depression risk score and time to recovery from depressive episodes, improve functioning and quality of life and increase the number of depression free days, length of wellness intervals and time to depression recurrence more than treatment as usual. _____ Previous study hypothesis: The group CBT intervention evaluated in this trial will increase the time to depressive disorder in young people aged 13-17 years who are at increased risk for developing depression compared to treatment as usual. The group CBT intervention will reduce symptoms of mental health problems, depression risk score and time to recovery from depressive episodes, improve functioning and quality of life and increase the number of depression free days, length of wellness intervals and time to depression recurrence more than treatment as usual. |
| Ethics approval(s) | Approved 28/09/2022, Wales REC 5 (Health and Care Research Wales Support Centre, Bangor, CF11 9AB, UK; +44 2922 941106; Wales.REC5@Wales.nhs.uk), ref: 22/WA/0254 |
| Condition | Prevention of depression in young people at increased risk for depression |
| Intervention | Current interventions as of 22/08/2024: Following parental depression treatment optimization for all parents who are depressed at the recruitment/screening stage of the study, and following baseline assessments, young people will be allocated randomly to either receive 1. Intervention plus treatment as usual (TAU), OR 2. TAU. Young people will be randomised 1:1 via simple permuted block randomisation and the unit of randomisation will be the young person. Each young person randomised to the intervention plus TAU arm will be assigned to an online therapy group (maximum size: 8 young people) and will receive the psychological intervention. The intervention consists of group therapy sessions delivered in two phases – the acute and continuation phase. The acute phase consists of eight up to 90-minute sessions delivered online by a trained therapist once a week. The acute phase is followed by 3 continuation sessions, which are held monthly. The online sessions start by giving an overview of depression and its relationship to stressful situations. They then focus on training young people in cognitive-restructuring skills and in modifying irrational or negative thoughts, as these are hypothesised to contribute to the development and maintenance of depressive disorder. Sessions will also cover problem solving strategies, behavioural activation, relaxation, and assertiveness training. Young people in the intervention group will also be free to continue any existing treatment and begin new treatments outside the study, alongside the trial intervention. Young people in the TAU arm will not receive the psychological intervention, though they will be able to continue with any treatment that they already receive and will be free to begin new treatment outside the study. All participants in both the intervention + TAU and the TAU arms will be followed up for 9 months via questionnaires and interviews. _____ Previous interventions: Following parental depression treatment optimization for all parents who are depressed at the recruitment/screening stage of the study, and following baseline assessments, young people will be allocated randomly to either receive 1. Intervention plus treatment as usual (TAU), OR 2. TAU. Young people will be randomised 1:1 via simple permuted block randomisation and the unit of randomisation will be the young person. Each young person randomised to the intervention plus TAU arm will be assigned to an online therapy group (maximum size: 8 young people) and will receive the psychological intervention. The intervention consists of group therapy sessions delivered in two phases – the acute and continuation phase. The acute phase consists of eight 90-minute sessions delivered online by a trained therapist once a week. The acute phase is followed by 3 continuation sessions, which are held monthly. The online sessions start by giving an overview of depression and its relationship to stressful situations. They then focus on training young people in cognitive-restructuring skills and in modifying irrational or negative thoughts, as these are hypothesised to contribute to the development and maintenance of depressive disorder. Sessions will also cover problem solving strategies, behavioural activation, relaxation, and assertiveness training. Young people in the intervention group will also be free to continue any existing treatment and begin new treatments outside the study, alongside the trial intervention. Young people in the TAU arm will not receive the psychological intervention, though they will be able to continue with any treatment that they already receive and will be free to begin new treatment outside the study. All participants in both the intervention + TAU and the TAU arms will be followed up for 9 months via questionnaires and interviews. |
| Intervention type | Behavioural |
| Primary outcome measure | Time to a DSM-5 major depressive episode occurring in the young person during the 9 month follow up period (measured using the young person and parent rated Longitudinal Interview Follow-up Evaluation (LIFE) at 9 months) |
| Secondary outcome measures | 1. Number of depression free weeks, length of wellness intervals, time to recovery from depressive episodes and time to recurrence of depressive episodes in the 9-month follow up period assessed with the LIFE 2. Depressive symptoms assessed with the CES-D at 9 months 3. Anxiety symptoms assessed using the Revised Children's Anxiety and Depression scale (RCADS) at 9 months 4. Irritability symptoms assessed using the Affective Reactivity Index (ARI) at 9 months 5. Quality of life assessed using EQ-5D-Y at 9 months 6. Developmental competence assessed using Developmental Competence Scale at 9 months 7. Functional impairment and mental health related impairment assessed using Children's Global assessment Scale (cGAS) at 9 months 8. Individual depression risk score (an individual risk algorithm developed at Cardiff University which assesses 3 year risk of depression) 9. Service use and treatment assessed with the CSRI. Data on potential mediators will also be collected at baseline, 3 month and 9 month follow-up: 10. Negative self-beliefs assessed with the DAS-C 11. Self-efficacy and problem solving assessed with the GSE 12. Perceived stress assessed with the PSS 13. Behavioural activation assessed with the BADS-SF 14. Interpersonal relationships assessed with the CBQ, CRPBI, and the child disclosure subscale from the parent monitoring measure |
| Overall study start date | 01/03/2021 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | up to 400 |
| Participant inclusion criteria | Current inclusion criteria as of 22/08/2024: 1. Adolescents aged 13-19 years at study entry 2. Experiencing subthreshold depressive symptoms (CES-D score >=16) , and/or has a history of depression according to DSM-5. 3. Living with a parent (biological or non-biological) who has a history of recurrent unipolar depression (at least 1 previous episodes) who is willing and able to engage with a depression treatment plan 4. Both young person and parent have access to the internet via a desktop/laptop/phone/tablet and have a valid email address or mobile phone number 5. Both young person and parent have the ability to complete trial activities as specified in the protocol, e.g., sufficient understanding of English language, absence of learning disability that would impair ability to participate, and for the young person, ability to participate in small group therapy sessions ______ Previous inclusion criteria: 1. Adolescents aged 13-17 years at study entry 2. Experiencing subthreshold depressive symptoms (CES-D score >=20) , and/or has a history of depression according to DSM-5. 3. Living with a parent (biological or non-biological) who has a history of recurrent unipolar depression (at least 2 previous episodes) who is willing and able to engage with a depression treatment plan 4. Both young person and parent have access to the internet via a desktop/laptop/phone/tablet and have a valid email address or mobile phone number 5. Both young person and parent have the ability to complete trial activities as specified in the protocol, e.g., sufficient understanding of English language, absence of learning disability that would impair ability to participate, and for the young person, ability to participate in small group therapy sessions |
| Participant exclusion criteria | Current exclusion criteria as of 22/08/2024: 1. Young person already receiving specialist treatment for depression (e.g. currently on antidepressants, or is currently receiving cognitive behavioural therapy (CBT)) 2. Young person has a current diagnosis of depression as given by a doctor or healthcare professional 3. Young person has been told by a doctor or healthcare professional that they have a primary diagnosis of bipolar disorder, schizophrenia, eating disorder or alcohol/drug dependence or have generalized learning difficulties, that the parent judges would prevent them from participating in trial activities 4. Parent has been told by a doctor or healthcare professional that they have a diagnosis of bipolar disorder, schizophrenia or personality disorder 5. Parent is receiving treatment from secondary mental health services (e.g. community mental health team or psychiatrist) 6. Parent or young person are not resident in the UK _____ Previous exclusion criteria as of 01/03/2024: 1. Young person already receiving specialist treatment for depression (e.g. currently on antidepressants, or has received a full course of cognitive behavioural therapy (CBT) previously) 2. Young person is experiencing a current depression episode at baseline that meets DSM-5 diagnostic criteria (i.e. five or more symptoms including either depressed mood/irritable mood and loss of interest that are present during the same 2-week period and represent a change from previous functioning) 3. Young person has been told by a doctor or healthcare professional that they have a primary diagnosis of bipolar disorder, schizophrenia, eating disorder or alcohol/drug dependence or have generalized learning difficulties, that the parent judges would prevent them from participating in trial activities 4. Parent has been told by a doctor or healthcare professional that they have a diagnosis of bipolar disorder, schizophrenia or personality disorder 5. Parent is receiving treatment from secondary mental health services (e.g. community mental health team or psychiatrist) 6. Parent or young person are not resident in the UK _____ Previous exclusion criteria: 1. Young person already receiving specialist treatment for depression (e.g. currently on antidepressants, or has received a full course of cognitive behavioural therapy (CBT) previously) 2. Young person is experiencing a current depression episode at baseline that meets DSM-5 diagnostic criteria (i.e. five or more symptoms including either depressed mood/irritable mood and loss of interest that are present during the same 2-week period and represent a change from previous functioning) 3. Young person has been told by a doctor or healthcare professional that they have a primary diagnosis of bipolar disorder, schizophrenia, eating disorder or alcohol/drug dependence or have generalized learning difficulties, that the parent judges would prevent them from participating in trial activities 4. Parent has been told by a doctor or healthcare professional that they have a diagnosis of bipolar disorder, schizophrenia, personality disorder or post-traumatic stress disorder 5. Parent is receiving treatment from secondary mental health services (e.g. community mental health team or psychiatrist) 6. Parent or young person are not resident in the UK |
| Recruitment start date | 21/08/2023 |
| Recruitment end date | 31/08/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
Unit 3
Navigation Park
Mountain Ash
CF45 4SN
United Kingdom
Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom
Sponsor information
University/education
Research and Innovation Services
Cardiff University
Joint Research Office
2nd Floor
Lakeside Building
University Hosptial of Wales
Cardiff
CF14 4XW
Wales
United Kingdom
| Phone | +44 2920879277 |
|---|---|
| falconerhe@cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Wolfson Foundation, wolfsonfdn
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We plan to publish the trial protocol paper in a scientific peer reviewed journal prior to the start of the trial, and the findings in a good quality peer reviewed journal on completion of the trial. Findings will also be disseminated to academics, clinicians and policy makers, and to participating families in the form of reports, newsletters and social media once the study has been completed. |
| IPD sharing plan | The datasets generated are not expected to be made publicly available. However, the data or information generated as part of this trial may be shared with other researchers in the UK or abroad in the future. The data will not identify the participant by name (pseudoanonymised data), and any future research using this data will be in the interest of public health and care. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Protocol file | version 5.8 | 05/03/2025 | 25/03/2025 | No | No |
Additional files
Editorial Notes
25/03/2025: The following changes were made:
1. The overall study end date was changed from 31/03/2026 to 31/12/2026.
2. Protocol file added (not peer reviewed).
22/08/2024: The following changes were made to the trial record:
1. Contact details were changed.
2. The study hypothesis was changed.
3. The interventions were changed.
4. The inclusion criteria were changed.
5. The exclusion criteria were changed.
01/03/2024: The exclusion criteria were updated. The recruitment end date was changed from 01/12/2024 to 31/08/2025.
04/08/2023: The recruitment start date has been changed from 01/05/2023 to 21/08/2023.
03/04/2023: Internal review.
15/03/2023: Trial's existence confirmed by Wales REC 5.
