Depression Mental and Behavioural Disorders
Conditions
Interventions
This is a full-scale randomised controlled trial with an internal pilot to assess the clinical, cost-effectiveness and acceptability of a novel blended behavioural activation (BA) intervention, the BA
Sponsors
Greater Manchester Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
11 Years to 17.5 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/09/2024: 1. Young people aged 11-17 years. Participants will be accepted up to 17 years and 6 months but not beyond 2. Young people must have been recently accepted into specialist CAMH (=6 weeks) 3. Young people must score =27 on the Moods and Feelings Questionnaire (this is the standardised cut-off by which elevated symptoms of depression warrant further assessment and potential intervention) 4. Young people must provide consent, or assent along with their carer’s consent (if applicable), to participate in the study Previous inclusion criteria: 1. Young people aged 11-17 years. Participants will be accepted up to their 17th birthday and on the birthday itself, but not beyond 2. Young people must have been recently accepted into specialist CAMH (=4 weeks) 3. Young people must score =27 on the Moods and Feelings Questionnaire (this is the standardised cut-off by which elevated symptoms of depression warrant further assessment and potential intervention) 4. Young people must provide consent, or assent along with their carer’s consent (if applicable), to participate in the study
Exclusion criteria
Exclusion criteria: 1. Young people with severe mental illness which is not primarily depressive and requires a different treatment pathway (schizophrenia/non-depressive psychosis, current mania, anorexia, drug and alcohol addiction) 2. Young people who cannot speak English to a sufficient level to understand the intervention and research materials 3. Young people who have an intellectual disability of a level which prevents adequate understanding of the study or intervention materials (clinical judgement) 4. Young people at a high risk of imminent suicide and therefore need a different pathway of care and support (clinical judgement) 5. Young people who present with a high frequency of severe self-harm and therefore need a different pathway of care and support (clinical judgement) 6. Young people who have received 8 sessions of cognitive behavioural therapy (or BA) in the past 6 months 7. If there is more than one eligible child in the family, only one child will be consented into the study and randomised and the same randomised treatment will be offered to the sibling* *This is applicable to a young person who has a sibling already consented into the study (regardless of whether the sibling is being actively followed up), and if two or more siblings are assessed and accepted into CAMHS at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression in young people is measured using the self-reported Moods and Feelings Questionnaire at baseline, 12 weeks, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression in young people is measured using the self-reported Strengths and Difficulties Questionnaire (SDQ) at baseline, 12 weeks, 6 months and 12 months 2. Depression and anxiety in young people are measured using the self-reported Revised Children’s Anxiety and Depression Scale (RACDS) Brief Version at baseline, 12 weeks, 6 months and 12 months 3. Descriptive accounts of young person’s mental health are measured through the Development and Wellbeing Assessment (DAWBA) at baseline 4. Current engagement in activities in young people is measured using the self-reported Behavioural Activation for Depression at baseline, 12 weeks, 6 months and 12 months 5. Self-harm and suicide behaviours in young people are measured using the self-reported self-harm and suicidality questionnaire at baseline, 12 weeks, 6 months and 12 months 6. Goal achievement in young people is measured using the self-reported goal-based outcome measure at baseline, 12 weeks, 6 months and 12 months 7. Quality of life in young people is measured using the self-reported Child Health Utility at baseline, 12 weeks, 6 months and 12 months 8. Quality of life in young people is measured using the self-reported EQ-5D-Y at baseline and 6 months 9. Service use in young people is measured using the self-reported Healthcare Service Use schedule at baseline, 12 weeks, 6 months and 12 months 10. Elements of behavioural activation in therapy for young people are measured using the self-reported Aspects of Care Checklist at 12 weeks, 6 months and 12 months 11. Relationship with a therapist and young people is measured using the self-reported Working Alliance Inventory halfway through therapy delivery 12. Experiences of BA treatment for young people are measured using a self-reported end-of-treatment questionnaire after the final session of BA therapy 13. Depression in young people is measured using parent completed Strengths and Difficulties Questionnaire at baseline, 12 weeks, 6 months, and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma;Camila Standley;Piccolo-Lawrance
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Outcome results
None listed