Depression and anxiety in children and young people Mental and Behavioural Disorders
Conditions
Interventions
During the SMILE study, participants will be asked to participate in a digital psychosocial intervention in the form of a serious game app and a companion app. Participants will be invited to play a s
these will be allocated pragmatically between sites and adjusted in size and distribution if indicated by the interim analyses. There is no randomisation at the individual level. Clusters will be blin
Sponsors
University of Edinburgh
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adolescents and young adults aged 10-24 years 2. Participants under 16 require consent from a parent or guardian, as well as their own agreement to participate. Informed Consent Forms and their digital equivalents will be tailored to be age-appropriate, ensuring both guardians and participants can make informed decisions. If either the parent or the participant does not agree, the participant will not be included in the study 3. Must complete measures of primary outcome 4. Must have normal or corrected to normal vision
Exclusion criteria
Exclusion criteria: 1. Unable to consent to participation 2. Have a current confirmed diagnosis or treatment episode for: 2.1. severe mental disorder (schizophrenia, bipolar disorder, severe depression), 2.2. substance use disorder, 2.3. epileptic disorders, 2.4. gaming addiction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Depression is measured using the Patient Health Questionnaire for Adolescents (PHQ-A) at Weeks 2, 4 and 6 2. Depression is measured using the Patient Health Questionnaire (PHQ-9) at 2, 4 and 6 3. Anxiety is measured using the Penn-State Worry Questionnaire for Children (PSWQ-C) at Weeks 1, 3 and 5 4. Anxiety is measured using the Generalized Anxiety Disorder Scale (GAD-7) at Weeks 1, 3 and 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Well-being is measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at Weeks 1, 3 and 5 2. Resilience is measured using the Child and Youth Resilience Measure (CYRM-12) at Weeks 1, 3 and 5 3. Resilience is measured using the Brief Resilience Scale (BRS) at Weeks 1, 3 and 5 4. Privacy concerns are measured using an adapted online privacy concerns questionnaire at Week 1 5. Emotion regulation is measured using tailored Experience Sampling Methodology (ESM) items, 4 times a day at Weeks 1-6 6. Self-efficacy is measured using tailored ESM items, 4 times a day at Weeks 1-6 8. Social anxiety is measured using tailored ESM items, 4 times a day at Weeks 5 and 6 9. Usage of the SMILE apps is measured using the Unified Theory of Acceptance and Use of Technology Scale (UTAUT2) Post-test 10. User experience of the SMILE apps is measured using the User Experience Questionnaire short version (UEQ_S) Post-test | — |
Countries
Germany, Italy, Poland, Scotland, Slovakia, Spain, United Kingdom
Contacts
Public ContactMatthias Schwannauer
Outcome results
None listed