- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087850
Encouraging Social Inclusiveness as a Means to Improving Academic Performance
November 10, 2020 updated by: Amori Yee Mikami, University of British Columbia
Encouraging Social Inclusiveness as a Means to Improving Academic Performance for Children at Risk Attention-Deficit/Hyperactivity Disorder (ADHD) and Typical Children
Children's peer relationships in elementary school are important to promote their academic learning and their social-emotional development.
Many children with or at risk for Attention-Deficit/Hyperactivity Disorder (ADHD) have difficulty being accepted and getting along with their classroom peers.
This study tested a classroom intervention that aimed to help improve the peer relationships of elementary school age children, with a particular focus on children with or at risk for ADHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
558
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
-General education teachers of grades K-5 or children in these teachers' classrooms
Exclusion Criteria:
-None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Making Socially Accepting Inclusive Classrooms (MOSAIC)
|
Using a consultation model, study staff members met with teachers approximately twice per month and observed them an additional two times per month.
The goal was to help teachers implement practices that create a socially accepting classroom climate for children.
|
|
No Intervention: Typical Practice Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Peer Relationships - Peer Report
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through peer sociometric interviews.
The proportion of positive nominations, negative nominations, friendships, and the average liking rating received from peers will be calculated.
More positive nominations and friendship nominations, fewer negative nominations, and higher liking ratings are considered to be positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
|
Children's Peer Relationships - Child Self-Report
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through child self-report on the Classroom Life Measure.
There are 9 items about peer relationships, each answered from a scale of 0-4.
Scores range from 0-36 where higher numbers indicate more positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
|
Children's Peer Relationships - Teacher Report
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through teacher report on the Dishion Social Acceptance Scale.
The teacher estimates the proportion of classmates that like, dislike, and are neutral toward the child.
Higher proportions of liking and lower proportions of disliking and neutrality represent positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Academic Functioning - Teacher Report
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through teacher report on the Academic Competence Evaluation Scales.
This is a normed measure with 10 items about interpersonal skills, 8 about engagement, and 11 about motivation, each rated on a 1-5 scale.
Each subscale represents the sum of the items on the subscale, and higher scores indicate positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
|
Children's Academic Functioning - Teacher Report
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through teacher report on the Academic Performance Rating Scales.
This is a 19 item scale with each item rated on a 1-5 metric.
Some items are reverse scored.
Higher scores indicate positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
|
Children's Academic Functioning - Grades
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through grades on children's report cards.
Higher grades indicates positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
|
Children's Social Behaviors - Observations
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through behavioral observations on children's classroom behaviors.
This is a proportion score indicating children's off-task, interfering, defiant, and verbally aggressive behaviors.
Lower scores indicate positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
|
Children's Social Behaviors - Observations
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through behavioral observations on messages written by children to one another, on codes representing the connection, support, and positivity in the messages children receive.
Higher scores on these indicators and lower scores on indicators of platitudes indicate positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
|
Children's Problem Behaviors - Teacher Report
Time Frame: Change from baseline to post-test (approximately 7 months after baseline)
|
Assessed through teacher report of ADHD symptoms on the ADHD-4 Rating Scale.
There are 18 symptom items, each rated on a scale of 0-3.
Lower scores indicate positive outcomes.
|
Change from baseline to post-test (approximately 7 months after baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amori Mikami, PhD, University of British Columbia
- Principal Investigator: Julie Owens, PhD, Ohio University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2016
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
September 6, 2019
First Submitted That Met QC Criteria
September 10, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
November 12, 2020
Last Update Submitted That Met QC Criteria
November 10, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R324A16005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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