MyFILM: A Pilot Study for Social-Emotional Learning in Clinical Youth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorMark Sinyor
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Have active psychosis or mania
Have severe cognitive, developmental, and/or behavioural limitations preventing meaningful participation
Trial design
Design model
Single group
Treatments tested in this trial
MyFILM
Behavioral9 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.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: MyFILMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 intervention2
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 interventionSecondary outcomes
1
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.
Time frame
Baseline and week 92
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.
Time frame
Baseline and week 93
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.
Time frame
Baseline and week 94
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.
Time frame
Baseline and week 9Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mark Sinyor
Lead sponsor
Sunnybrook Health Sciences Centre
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: