Trial record 1 of 4 for:
mikami
Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention Deficit Hyperactivity Disorder (ADHD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01133028 |
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Recruitment Status : Unknown
Verified May 2010 by University of Virginia.
Recruitment status was: Not yet recruiting
First Posted : May 28, 2010
Last Update Posted : May 28, 2010
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Sponsor:
University of Virginia
Information provided by:
University of Virginia
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Behavioral: Behavioral contingency management Behavioral: Tolerance training | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention-Deficit/Hyperactivity Disorder (ADHD) |
| Study Start Date : | January 2011 |
| Estimated Primary Completion Date : | September 2011 |
| Estimated Study Completion Date : | June 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Attention Deficit Hyperactivity Disorder
| Arm | Intervention/treatment |
|---|---|
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Experimental: Combined
This represents a combination of the tolerance training and behavioral management interventions together.
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Behavioral: Behavioral contingency management
Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors. Behavioral: Tolerance training Teachers will be instructed in procedures to encourage the peer group to be accepting of children with ADHD. |
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Active Comparator: Behavioral management
This represents the behavioral contingency management intervention only.
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Behavioral: Behavioral contingency management
Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 6 Years to 8 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Children ages 6-8
- Primary diagnosis of ADHD
Exclusion Criteria:
- Pervasive Developmental Disorder
- Verbal IQ below 75
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133028
Contacts
| Contact: Amori Y Mikami, PhD | 4342432327 | mikami@virginia.edu |
Locations
| United States, Virginia | |
| University of Virginia | Not yet recruiting |
| Charlottesville, Virginia, United States, 22904 | |
| Contact: Amori Y Mikami, PhD 434-243-2327 mikami@virginia.edu | |
| Principal Investigator: Amori Y Mikami, PhD | |
Sponsors and Collaborators
University of Virginia
Investigators
| Principal Investigator: | Amori Y Mikami, PhD | University of Virginia |
| Responsible Party: | Amori Y Mikami, Assistant Professor, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT01133028 History of Changes |
| Other Study ID Numbers: |
2010-0066-00 |
| First Posted: | May 28, 2010 Key Record Dates |
| Last Update Posted: | May 28, 2010 |
| Last Verified: | May 2010 |
Keywords provided by University of Virginia:
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Attention Deficit Hyperactivity Disorder (ADHD) |
Additional relevant MeSH terms:
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Disease Attention Deficit Disorder with Hyperactivity Hyperkinesis Pathologic Processes Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders |
Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |