- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01133028
Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention Deficit Hyperactivity Disorder (ADHD)
May 26, 2010 updated by: University of Virginia
Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Children with Attention-Deficit/Hyperactivity Disorder (ADHD) comprise about 5-10% of the elementary school-age population.
One place where children with ADHD have great difficulty is in being accepted by peers and in making friends.
It has unfortunately been very difficult for the field to find good treatments for peer relationship problems for this population.
Even when children with ADHD do improve their behavior, it is common that peers do not seem to like the child with ADHD any better.
This may happen because children often have negative reputations with their classmates that are hard to change.
That is, once a class of children get the impression that one child is disliked or the social outcast, even if that child's ADHD symptoms get better, the peer group may not notice any of these improvements.
It is hypothesized that the elementary school teacher may be able to help peers notice positive behavior changes in children with ADHD when they do occur.
This clinical trial will design and pilot-test an intervention that would train teachers in classroom practices to reduce the peer rejection of students with ADHD.
The pilot test will be conducted in a summer program created to be similar to a regular school classroom in structure.
If the treatment seems to succeed in the summer program, then it will be tried in regular classrooms in a future study.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Charlottesville, Virginia, United States, 22904
- University of Virginia
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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
6 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children ages 6-8
- Primary diagnosis of ADHD
Exclusion Criteria:
- Pervasive Developmental Disorder
- Verbal IQ below 75
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combined
This represents a combination of the tolerance training and behavioral management interventions together.
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Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors.
Teachers will be instructed in procedures to encourage the peer group to be accepting of children with ADHD.
|
|
Active Comparator: Behavioral management
This represents the behavioral contingency management intervention only.
|
Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Peer Relationships
Time Frame: The first day of the treatment and the last day of the treatment (two weeks later)
|
This is collected in the summer program in which the intervention will be adminstered.
On the first day of the program (before treatment begins), pre-test measures will be taken.
They will be re-taken on the last day of the program two weeks later (on the last day of treatment).
Peer relationships will be assessed by peer sociometric interviews.
Proportion scores of peer acceptance, reciprocated friendship, and inclusion in social networks will be calculated, and changes in these outcomes over the summer prorgam will be considered as evidence to evaluate the treatment.
|
The first day of the treatment and the last day of the treatment (two weeks later)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Behavior Problems
Time Frame: The first day of the treatment and the last day of the treatment (two weeks later)
|
This measure will be collected on the same time frame as is the primary outcome measure.
Children's behavior problems (aggression, inattention, hyperactivity/impulsivity, social withdrawal) will be assessed by teacher report and by observation.
Changes in behavior problems during this period will be considered as evidence for the efficacy of the treatment.
|
The first day of the treatment and the last day of the treatment (two weeks later)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amori Y Mikami, PhD, University of Virginia
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
January 1, 2011
Primary Completion (Anticipated)
September 1, 2011
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
May 10, 2010
First Submitted That Met QC Criteria
May 26, 2010
First Posted (Estimate)
May 28, 2010
Study Record Updates
Last Update Posted (Estimate)
May 28, 2010
Last Update Submitted That Met QC Criteria
May 26, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-0066-00
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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