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

No phase Interventional Mood Disorders Anxiety Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MyFILM.
Who it may be relevant to
Registry conditions: Mood Disorders, Anxiety Disorders. Basic parameters: 9 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Behavioral MyFILM
    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 con

Primary outcome measures

  • Completion rate [Time frame: At the end of the 9-week intervention]
  • Satisfaction and Acceptability Score [Time frame: At the end of the 9-week intervention]
Secondary outcome measures (6)
  • Change from baseline in SELIS score at the end of the intervention (after Session 9) [Time frame: Baseline and week 9]
  • Change from baseline in KidCOPE score at the end of the intervention (after Session 9) [Time frame: Baseline and week 9]
  • Change from baseline in MFQ-SF score at the end of the intervention (after Session 9) [Time frame: Baseline and week 9]
  • Change from baseline in RCADS score at the end of the intervention (after Session 9) [Time frame: Baseline and week 9]
  • Change from baseline in MFQ [Parent] score at the end of the intervention (after Session 9) [Time frame: Baseline and week 9]
  • Change from baseline in RCADS [Parent] score at the end of the intervention (after Session 9) [Time frame: Baseline and week 9]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07708168 · 7272

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗