Anxiety Disorders, Mood Disorders
Conditions
Brief summary
The objective of this pilot study is to evaluate the feasibility and acceptability of MyFILM as a weekly group intervention for children aged 9-12 in a clinical setting. We will also gather preliminary data to explore changes in clinical metrics following participation in MyFILM in preparation for a full-scale clinical trial. Primary Objective (Feasibility): To determine whether a substantial proportion of participants complete the MyFILM intervention. Primary Objective (Acceptability): To determine whether the MyFILM intervention is acceptable to 9-12-year-old participants in a clinical setting. Secondary Objective (Clinical Effectiveness): To determine whether participation in MyFILM show preliminary evidence of improvement in social-emotional skills, coping ability, and reduction in anxiety and depression symptoms. Participants will: Participate in 9 sessions of a structured group-based program.
Interventions
BEHAVIORALMyFILM
9 sessions of MyFILM: The intervention will consist of a 9-week, closed-group program delivered by a trained MSW. Sessions will occur weekly, with most sessions lasting approximately 1 hour, except for Sessions 2 and 6 (approximately 2 hours each) to accommodate in-session viewing of Inside Out films. Content comprises of psychoeducation, mental health literacy (MHL), social-emotional learning (SEL), and CBT-informed coping skills, using structured film vignettes. Sessions 1-4 introduce core concepts and skills anchored in the first film; Sessions 5-8 extend these competencies using the second film; Session 9 focuses on consolidation and skill integration.
Sponsors
Mark Sinyor
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Be between 9 and 12 years of age at enrollment * Be receiving outpatient care through Sunnybrook Health Sciences Centre * Demonstrate elevated risk (first-degree relative with a mental illness, experiencing a major life stressor as judged by the treating physician and investigator), subclinical symptoms (symptoms of a mood and/or anxiety disorder that do not meet the threshold of a clinical diagnosis), or diagnosed mood and/or anxiety-related concerns * Be able to participate in group-based discussions and activities in English * Have parent/guardian consent and participant assent
Exclusion criteria
* Have active psychosis or mania * Have severe cognitive, developmental, and/or behavioural limitations preventing meaningful participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate | At the end of the 9-week intervention | Proportion of participants who enroll in the study and complete the intervention, defined as attendance at least 70% of the scheduled sessions (i.e., ≥6 of 9 sessions). |
| Satisfaction and Acceptability Score | At the end of the 9-week intervention | The number and proportion of participants who rate the intervention positively on a post-intervention Satisfaction and Acceptability Questionnaire composed of 5-point Likert scale items. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in SELIS score at the end of the intervention (after Session 9) | Baseline and week 9 | The Social and Emotional Learning Indicator System (SELIS) Survey, which assesses core social-emotional learning competencies including self-awareness, self-management, social awareness, and relationship skills. |
| Change from baseline in KidCOPE score at the end of the intervention (after Session 9) | Baseline and week 9 | The KidCOPE - Child Version, a self-report measure evaluating coping strategies used in response to stress. |
| Change from baseline in MFQ-SF score at the end of the intervention (after Session 9) | Baseline and week 9 | The Mood and Feelings Questionnaire - Short Form (MFQ-SF), a widely used measure of depressive symptoms in children and adolescents. |
| Change from baseline in RCADS score at the end of the intervention (after Session 9) | Baseline and week 9 | The Revised Children's Anxiety and Depression Scale (RCADS) - Generalized Anxiety and Social Phobia subscales, which assess symptoms of anxiety. |
| Change from baseline in MFQ [Parent] score at the end of the intervention (after Session 9) | Baseline and week 9 | The Mood and Feelings Questionnaire - Short Form (MFQ-SF), a widely used measure of depressive symptoms in children and adolescents. |
| Change from baseline in RCADS [Parent] score at the end of the intervention (after Session 9) | Baseline and week 9 | The Revised Children's Anxiety and Depression Scale (RCADS) - Generalized Anxiety and Social Phobia subscales, which assess symptoms of anxiety. |
Contacts
CONTACTRachel Lebovic, MHS
Outcome results
None listed