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NCT Number: NCT07708168

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

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.

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Key information

Conditions

Mood Disorders Anxiety Disorders Mental Disorders

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyFILM

Behavioral

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.

Primary outcomes

  1. Completion rate

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

    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).

  2. Satisfaction and Acceptability Score

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

    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.

Secondary outcomes

  1. Change from baseline in SELIS score at the end of the intervention (after Session 9)

    Time frame: Baseline and week 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.

  2. Change from baseline in KidCOPE score at the end of the intervention (after Session 9)

    Time frame: Baseline and week 9

    The KidCOPE - Child Version, a self-report measure evaluating coping strategies used in response to stress.

  3. Change from baseline in MFQ-SF score at the end of the intervention (after Session 9)

    Time frame: Baseline and week 9

    The Mood and Feelings Questionnaire - Short Form (MFQ-SF), a widely used measure of depressive symptoms in children and adolescents.

  4. Change from baseline in RCADS score at the end of the intervention (after Session 9)

    Time frame: Baseline and week 9

    The Revised Children's Anxiety and Depression Scale (RCADS) - Generalized Anxiety and Social Phobia subscales, which assess symptoms of anxiety.

  5. Change from baseline in MFQ [Parent] score at the end of the intervention (after Session 9)

    Time frame: Baseline and week 9

    The Mood and Feelings Questionnaire - Short Form (MFQ-SF), a widely used measure of depressive symptoms in children and adolescents.

  6. Change from baseline in RCADS [Parent] score at the end of the intervention (after Session 9)

    Time frame: Baseline and week 9

    The Revised Children's Anxiety and Depression Scale (RCADS) - Generalized Anxiety and Social Phobia subscales, which assess symptoms of anxiety.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Lebovic, MHS

CONTACT

[email protected]

404-444-6024

Sponsors and collaborators

Lead sponsor

Mark Sinyor

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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