NCT07708168

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 12, 2026

Last Update Submit

July 12, 2026

Conditions

Mood DisordersAnxiety Disorders

Outcome Measures

Primary Outcomes (2)

  • 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).

    At the end of the 9-week intervention

  • 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.

    At the end of the 9-week intervention

Secondary Outcomes (6)

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

    Baseline and week 9

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

    Baseline and week 9

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

    Baseline and week 9

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

    Baseline and week 9

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

    Baseline and week 9

  • +1 more secondary outcomes

Study Arms (1)

MyFILM

EXPERIMENTAL

The arm will consist of a 9-week structured and closed-group program of MyFILM intervention.

Behavioral: MyFILM

Interventions

MyFILMBEHAVIORAL

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.

MyFILM

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Have active psychosis or mania
  • Have severe cognitive, developmental, and/or behavioural limitations preventing meaningful participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mood DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Rachel Lebovic, MHS

CONTACT

404-444-6024rachel.lebovic@sri.utoronto.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 16, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share