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
Qualifiers
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
Treatments tested in this trial
- MyFILM
Treatment groups
48 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Mark Sinyor
Lead sponsor
Sunnybrook Health Sciences Centre
Sponsor institution
Source ClinicalTrials.gov