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Skills for adolescent wellbeing

A randomised controlled trial of a group Cognitive Behavioural Therapy intervention for young people with parental treatment optimisation: skills for adolescent WELLbeing (SWELL)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13924193
Enrollment
400
Registered
2023-03-15
Start date
2023-08-21
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of depression in young people at increased risk for depression Mental and Behavioural Disorders

Interventions

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

Sponsors

Cardiff University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 19 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactRhys Williams-Thomas
ThomasR95@cardiff.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026