MyFILM: A Pilot Study for Social Emotional Learning in Clinical Youth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Completion rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Have active psychosis or mania
- •Have severe cognitive, developmental, and/or behavioural limitations preventing meaningful participation
结局指标
主要结局
Completion rate
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Change from baseline in RCADS [Parent] score at the end of the intervention (after Session 9)(Baseline and week 9)
研究者
Mark Sinyor
Staff Psychiatrist
Sunnybrook Health Sciences Centre