NCT04087850

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
558

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

September 6, 2019

Last Update Submit

November 10, 2020

Conditions

Keywords

peer relationships

Outcome Measures

Primary Outcomes (3)

  • Children's Peer Relationships - Peer Report

    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

    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

    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 Outcomes (6)

  • Children's Academic Functioning - Teacher Report

    Change from baseline to post-test (approximately 7 months after baseline)

  • Children's Academic Functioning - Teacher Report

    Change from baseline to post-test (approximately 7 months after baseline)

  • Children's Academic Functioning - Grades

    Change from baseline to post-test (approximately 7 months after baseline)

  • Children's Social Behaviors - Observations

    Change from baseline to post-test (approximately 7 months after baseline)

  • Children's Social Behaviors - Observations

    Change from baseline to post-test (approximately 7 months after baseline)

  • +1 more secondary outcomes

Study Arms (2)

Making Socially Accepting Inclusive Classrooms (MOSAIC)

EXPERIMENTAL
Behavioral: Making Socially Accepting Inclusive Classrooms

Typical Practice Control

NO INTERVENTION

Interventions

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.

Making Socially Accepting Inclusive Classrooms (MOSAIC)

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • General education teachers of grades K-5 or children in these teachers' classrooms

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amori Mikami, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Julie Owens, PhD

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Some outcome measures are collected through interviewing children and their classmates, who would not be aware of the intervention condition of their classroom; this is because the intervention is delivered to the classroom teacher outside of class time.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 12, 2019

Study Start

August 15, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share