Mood DisordersNCT07708168
MyFILM: A Pilot Study for Social-Emotional Learning in Clinical Youth
A study testing MyFILM in people with Mood Disorders and Anxiety Disorders, run by Mark Sinyor.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Mood Disorders, Anxiety Disorders
- What is being tested?
- MyFILM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Have active psychosis or mania
- Have severe cognitive, developmental, and/or behavioural limitations preventing meaningful participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Mood Disorders, Anxiety Disorders
- Being tested
- MyFILM
- Medical subject headings
- Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyFILMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MyFILM | Experimental | The arm will consist of a 9-week structured and closed-group program of MyFILM intervention. Receives: Behavioral: MyFILM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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)
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.
Measured: Baseline and week 9
Change from baseline in KidCOPE score at the end of the intervention (after Session 9)
The KidCOPE - Child Version, a self-report measure evaluating coping strategies used in response to stress.
Measured: Baseline and week 9
Change from baseline in MFQ-SF score at the end of the intervention (after Session 9)
The Mood and Feelings Questionnaire - Short Form (MFQ-SF), a widely used measure of depressive symptoms in children and adolescents.
Measured: Baseline and week 9
Change from baseline in RCADS score at the end of the intervention (after Session 9)
The Revised Children's Anxiety and Depression Scale (RCADS) - Generalized Anxiety and Social Phobia subscales, which assess symptoms of anxiety.
Measured: Baseline and week 9
Change from baseline in MFQ [Parent] score at the end of the intervention (after Session 9)
The Mood and Feelings Questionnaire - Short Form (MFQ-SF), a widely used measure of depressive symptoms in children and adolescents.
Measured: Baseline and week 9
Change from baseline in RCADS [Parent] score at the end of the intervention (after Session 9)
The Revised Children's Anxiety and Depression Scale (RCADS) - Generalized Anxiety and Social Phobia subscales, which assess symptoms of anxiety.
Measured: Baseline and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Sinyor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Sinyor, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708168
- Sponsor's protocol ID
- 7272
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyFILM: A Pilot Study for Social Emotional Learning in Clinical Youth
- ClinicalTrials.gov ID
- NCT07708168
- Acronym / sponsor ID
- 7272
- Conditions
- Mood Disorders, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mark SinyorUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyFILM | Experimental | Behavioral: MyFILMThe arm will consist of a 9-week structured and closed-group program of MyFILM intervention. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Have active psychosis or mania
- Have severe cognitive, developmental, and/or behavioural limitations preventing meaningful participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyFILM9 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. | Behavioural | MyFILM |
Primary outcome
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).
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing MyFILM in people with Mood Disorders and Anxiety Disorders, run by Mark Sinyor.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Lebovic, MHS (404-444-6024, rachel.lebovic@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: At the end of the 9-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.