ADHDNCT04087850
Encouraging Social Inclusiveness as a Means to Improving Academic Performance
A study testing Making Socially Accepting Inclusive Classrooms in people with ADHD, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Making Socially Accepting Inclusive Classrooms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2016to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -General education teachers of grades K-5 or children in these teachers' classrooms
Who cannot join
- -None
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- Making Socially Accepting Inclusive Classrooms
- Keywords
- peer relationships
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making Socially Accepting Inclusive ClassroomsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Making Socially Accepting Inclusive Classrooms (MOSAIC) | Experimental | Not described Receives: Behavioral: Making Socially Accepting Inclusive Classrooms |
| Typical Practice Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to post-test (approximately 7 months after baseline)
Secondary outcomes (6)
Children's Academic Functioning - Teacher Report
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.
Measured: Change from baseline to post-test (approximately 7 months after baseline)
Children's Academic Functioning - Teacher Report
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.
Measured: Change from baseline to post-test (approximately 7 months after baseline)
Children's Academic Functioning - Grades
Assessed through grades on children's report cards. Higher grades indicates positive outcomes.
Measured: Change from baseline to post-test (approximately 7 months after baseline)
Children's Social Behaviors - Observations
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.
Measured: Change from baseline to post-test (approximately 7 months after baseline)
Children's Social Behaviors - Observations
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.
Measured: Change from baseline to post-test (approximately 7 months after baseline)
Children's Problem Behaviors - Teacher Report
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.
Measured: Change from baseline to post-test (approximately 7 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start15 Aug 2016
- Primary completion1 Jul 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amori Yee Mikami, University of British Columbia
- Investigators
- Amori Mikami, PhD, Principal investigator, University of British ColumbiaJulie Owens, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087850
- Sponsor's protocol ID
- R324A16005
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2019
- Last updated
- 12 Nov 2020
- 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 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Social Inclusiveness as a Means to Improving Academic Performance for Children at Risk Attention-Deficit/Hyperactivity Disorder (ADHD) and Typical Children
- ClinicalTrials.gov ID
- NCT04087850
- Acronym / sponsor ID
- R324A16005
- Conditions
- ADHD
- Keywords
- peer relationships
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 12 Sep 2019 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Making Socially Accepting Inclusive Classrooms (MOSAIC) | Experimental | Behavioral: Making Socially Accepting Inclusive Classrooms |
| Typical Practice Control | No intervention | – |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -General education teachers of grades K-5 or children in these teachers' classrooms
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| Making Socially Accepting Inclusive ClassroomsUsing 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. | Behavioural | Making Socially Accepting Inclusive Classrooms (MOSAIC) |
Primary outcome
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.
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.
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.
6 secondary outcomes
Children's Academic Functioning - Teacher Report
Time frame: 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)
Children's Academic Functioning - Grades
Time frame: 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)
Children's Social Behaviors - Observations
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- 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. This study is not recruiting at the moment.
Amori Mikami, PhD principal investigator
University of British Columbia
Julie Owens, PhD principal investigator
Ohio University
Questions about this trial
What is this clinical trial studying?
A study testing Making Socially Accepting Inclusive Classrooms in people with ADHD, run by University of British Columbia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Peer Relationships - Peer Report (time frame: Change from baseline to post-test (approximately 7 months after baseline)). The study lists 3 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 12 Nov 2020.