MyFILM: A Pilot Study for Social-Emotional Learning in Clinical Youth

N/ANot Yet RecruitingNCT07708168

Mark Sinyor48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mood Disorders Anxiety Disorders

Interventions

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.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: At the end of the 9-week intervention

Secondary Outcomes

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.