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NCT07708168
MyFILM: A Pilot Study for Social-Emotional Learning in Clinical Youth
Conditions: Mood Disorders, Anxiety Disorders
Sex: All
Ages: 9 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: Mark Sinyor
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07708168). StuddyBuddy aggregates publicly available trial information.