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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyFILM | Experimental | The arm will consist of a 9-week structured and closed-group program of MyFILM intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyFILM | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate | 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). | At the end of the 9-week intervention |
| Satisfaction and Acceptability Score | 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. | At the end of the 9-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in SELIS score at the end of the intervention (after Session 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. | Baseline and week 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Lebovic, MHS | Contact | 404-444-6024 | rachel.lebovic@sri.utoronto.ca |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
| Change from baseline in KidCOPE score at the end of the intervention (after Session 9) |
The KidCOPE - Child Version, a self-report measure evaluating coping strategies used in response to stress. |
| Baseline and week 9 |
| Change from baseline in MFQ-SF score at the end of the intervention (after Session 9) | The Mood and Feelings Questionnaire - Short Form (MFQ-SF), a widely used measure of depressive symptoms in children and adolescents. | Baseline and week 9 |
| Change from baseline in RCADS score at the end of the intervention (after Session 9) | The Revised Children's Anxiety and Depression Scale (RCADS) - Generalized Anxiety and Social Phobia subscales, which assess symptoms of anxiety. | Baseline and week 9 |
| Change from baseline in MFQ [Parent] score at the end of the intervention (after Session 9) | The Mood and Feelings Questionnaire - Short Form (MFQ-SF), a widely used measure of depressive symptoms in children and adolescents. | Baseline and week 9 |
| Change from baseline in RCADS [Parent] score at the end of the intervention (after Session 9) | The Revised Children's Anxiety and Depression Scale (RCADS) - Generalized Anxiety and Social Phobia subscales, which assess symptoms of anxiety. | Baseline and week 9 |