- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06619639
Feasibility of a Social-emotional Learning Curriculum in an After-school Program for Youth
Cluster Randomized Trial of a Novel Social-emotional Learning Curriculum in an After-school Program for Youth, 11-14 Years
The goal of this cluster randomized trial is to:
1. primary purpose: to determine the feasibility of a novel social-emotional learning curriculum when implemented in the beyond 3:30 after school program; 2a. secondary purpose: to determine whether the novel social-emotional learning curriculum has positive effects youth social emotional learning skills; 2b. secondary purpose: to determine whether the novel social-emotional learning curriculum has positive effects on youth resilience and overall functioning.
Participants:
- Beyond 3:30 facilitators
- Youth aged 11-14 who participate in the beyond 3:30 program
- Parents of youth who participate in the beyond 3:30 program
The main questions this study aims to answer are:
Primary Objectives:
- Is the novel social-emotional curriculum feasible within the beyond 3:30 after school program?
- Is the novel social-emotional curriculum acceptable within the beyond 3:30 after school program?
- Is the novel social-emotional curriculum appropriate within the beyond 3:30 after school program?
Secondary Objectives: Social-emotional learning skills 1. Have youth social-emotional learning skills improved as a result of participating in the novel social-emotional learning curriculum?
Secondary Objectives: Resilience and overall functioning
Have youth resilience abilities and overall functioning improved as a result of participating in the novel social-emotional learning program?
Comparator:
Primary objective: Feasibility - There is no comparison group for the feasibility objectives.
Secondary objective: Social-emotional learning skills
- The investigators will compare the intervention arm [10 sites within the beyond 3:30 program who will implement the EMPOWER social-emotional learning curriculum] with the usual programming control arm [10 sites within the beyond 3:30 program who will implement the usual beyond 3:30 program]
Secondary objective: Resilience and overall functioning
- The investigators will compare the intervention arm [10 sites within the beyond 3:30 program who will implement the EMPOWER social-emotional learning curriculum] with the usual programming control arm [10 sites within the beyond 3:30 program who will implement the usual beyond 3:30 program]
Measures:
Primary Objective: Feasibility
After school program staff participants in the intervention arm will be asked to complete:
- 3 feasibility measures (feasibility, acceptability, appropriateness of intervention) every 4-weeks after each social-emotional module they complete teaching.
- weekly fidelity checklists to assess feasibility.
Youth participants in the intervention arm will be asked to complete:
- the intervention appropriateness measure during the post-curriculum data collection time point.
Secondary Objective: Social-emotional learning skills
After school program staff participants in both intervention and usual programming arms will be asked to complete the following measure pre- and post-curriculum implementation:
- social-emotional learning skills measure for each youth aged 11-14 years in their class.
Youth participants in both intervention and usual programming arms will be asked to complete the following measure pre- and post-curriculum implementation:
- social-emotional learning skills measure Parents participants whose youth are in the intervention arm will be asked to participate in an interview.
Secondary objective: Resilience and overall functioning
After school program staff participants in both intervention and usual programming arms will be asked to complete the follow measures pre- and post-curriculum implementation:
- overall functioning measure for each youth aged 11-14 years in their class.
Youth participants in both intervention and usual programming arms will be asked to complete:
- resilience measure
Study Overview
Status
Intervention / Treatment
Detailed Description
The EMPOWER project is a community-academic partnership between 2 after school programs (beyond 3:30 and Visions of Science) and a mental health teaching hospital (Centre for Addiction and Mental Health). The main objective of this project is to bolster youth mental well-being by developing a novel social-emotional learning curriculum that after school programs can embed into their existing activities.
The curriculum is designed to improve youth's social emotional learning skills through the integration of short social-emotional learning lessons that are embedded into existing programming within an after school program. The curriculum is based on the Collaborative for Academic, Social and Emotional Learning's five core SEL competencies that include self-awareness, self-management, social awareness, relationship skills and decision-making.
The investigators have designed a pilot study to test the feasibility and efficacy of the EMPOWER social-emotional learning curriculum. Beyond 3:30 has 20 sites that are housed in schools across socially and economically vulnerable locations. We will randomize (based on class size and sites who participated in a previous trial of a part of the curriculum) 10 sites to be in the intervention and 10 sites to be in the usual programming control. The intervention arm will implement the 16-week EMPOWER social-emotional learning curriculum, while the usual programming control arm will implement regular beyond 3:30 programming.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
INCLUSION:
Youth participants must meet the following inclusion criteria:
- Must be a youth aged 11-14 years attending the beyond 3:30 program
- Must sign and date the informed consent form
- Must speak and understand English
Staff participants must meet the following inclusion criteria:
- Must be a facilitator of the beyond 3:30 program
- Must sign and date the informed consent form
- Must speak and understand English
Caregiver/parent participants must meet the following inclusion criteria:
- Must be a caregiver/parent of a youth aged 11-14 years attending the beyond 3:30 program. Caregivers/parents whose children decide not to participate in data collection are still able to participate in an interview post-SEL curriculum implementation.
- Must sign and date the informed consent form
- Must speak and understand English
EXCLUSION; None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual programming control (implement beyond 3:30 programming as usual)
Groups assigned to the usual programming control arm will deliver regular beyond 3:30 programming.
|
|
|
Experimental: Social-emotional learning curriculum
The intervention is the EMPOWER social-emotional learning curriculum.
|
EMPOWER is a 16-week social-emotional learning curriculum that is integrated into the after-school program context.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of Intervention
Time Frame: 20-weeks
|
Staff in the active intervention arm will complete the Acceptability of Intervention Measure (Weiner et al., 2017) measure after each social-emotional domain (self-awareness, self-management, social awareness and relationship skills, decision-making) is taught.
This is a 4-item, 5-point Likert-type scale that measures a composite acceptability of intervention score.
|
20-weeks
|
|
Intervention Appropriateness
Time Frame: 20-weeks
|
Staff in the active intervention arm will complete the Intervention Appropriateness (Weiner et al., 2017) measure after each social-emotional domain (self-awareness, self-management, social awareness and relationship skills, decision-making) is taught.
This is a 4-item, 5-point Likert-type scale that measures a composite appropriateness of intervention scale.
Youth in the intervention arm will complete the intervention appropriateness (Weiner et al., 2017) scale post-SEL curriculum implementation.
|
20-weeks
|
|
Feasibility of Intervention
Time Frame: 20-weeks
|
Staff in the active intervention arm will complete the Feasibility of Intervention (Weiner et al., 2017) measure after each social-emotional domain (self-awareness, self-management, social awareness and relationship skills, decision-making) is taught.
This is a 4-item, 5-point Likert-type scale that measures a composite feasibility of intervention score.
|
20-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall functioning
Time Frame: 20 weeks
|
KIDSCREEN 10 (Child Public Health, 2023) is a 10-item, 5-point Likert-type scale that measures global quality of life.
|
20 weeks
|
|
Resilience
Time Frame: 20 weeks
|
Connor-Davidson Resilience Scale (CD-RISC-10; 2007) is a 10-item, 5-point Likert-type scale that measures overall resilience. - Youth in active intervention and usual programming arms will complete this measure pre- and post-EMPOWER SEL curriculum intervention. |
20 weeks
|
|
Social-emotional learning skills
Time Frame: 20 weeks
|
Social Skills Improvement System - Social Emotional Learning (SSIS-SEL Brief Scale; (Elliot et al., 2020) is a 20-item, 4-point Likert-type scale that measures self-awareness, self-management, social awareness, relationship skills, and decision making as a composite score of social-emotional competency.
|
20 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brendan F Andrade, PhD, Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/111
- Les Lois Shaw Foundation (Other Identifier: Les Lois Shaw Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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