Mild to moderate depression Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 08/04/2025:
Study design and justification for the control arm
The study design is a single-blind pilot randomised controlled feasibility trial, with an embedded process ev
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/04/2025: 1. Adolescents aged 11 to 19 years on the date of consent 2. Identified to have symptoms indicative of mild to moderate depressive disorder 3. Able to provide written consent or, if under age 16, written parental consent and written/verbal child assent 4. Has access to a computer with internet access or smartphone or device to use SPARX and must be able to install and log in 5. Parent and adolescent able to read and write in English Previous inclusion criteria: 1. Adolescents aged 11 to 19 years on the date of consent referred to CAMHS or MHST 2. Presented at CAMHS/MHST for treatment with symptoms indicative of mild to moderate depressive disorder as confirmed by the PHQ-A 3. Able to provide written consent or, if under age 16, written parental consent and written/verbal child assent 4. Has access to a computer with internet access or smartphone or device to use SPARX and must be able to install and log in 5. Parent and adolescent able to read and write in English
Exclusion criteria
Exclusion criteria: 1. Depression assessed as being too severe to make SPARX an appropriate intervention as confirmed by the PHQ-A 2. High risk of current self-harm or suicide as confirmed by a clinician 3. Intellectual disability or physical limitations precluding the use of SPARX 4. Had (in the past three months) or currently having treatment with CBT/interpersonal therapy 5. Has another major mental health disorder (e.g., psychosis, eating disorder) where the primary focus was not depression as confirmed by a clinician or DAWBA 6. Safeguarding concerns that are currently not being managed (i.e., the young person is the subject of a safeguarding investigation) as confirmed by a clinician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mood measured using the Patient Health Questionnaire modified for adolescents (PHQ-A) at baseline (pre-intervention), 4 weeks (mid-intervention), and 8-10 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility measures: 1. Willingness of adolescent participants to be randomised (i.e., number withdrawing due to randomisation and numbers approached versus numbers consented/recruited) measured using trial data throughout the trial 2. Willingness of clinicians/MHST practitioners to recruit participants measured using trial data throughout the trial 3. Number of adolescents eligible, follow-up rates, response rates and adherence/compliance rates (i.e. SPARX module completion rates), numbers of outcome measure completion, retention to primary outcome measure, and recruitment rate (actual versus expected) measured using trial data throughout the trial 4. Demographics measured using the demographics questionnaire at baseline 5. Quality of Life measured using the EuroQol child EQ-5D-Y and EQ-5D-Y (Proxy version) at baseline and 8-10 weeks post-randomisation 6. Anxiety measured using the Revised Child Anxiety and Depression Scale (RCADS) at baseline and 8-10 weeks post-randomisation 7. Overall disease severity and change using the Clinical Global Impressions-Severity (CGI-S) scale at baseline 8. Symptom severity, treatment response and the efficacy of treatments measured using the Clinical Global Impressions-Improvement (CGI-I) scale at 8-10 weeks post-randomisation | — |
Countries
England, United Kingdom
Outcome results
None listed