Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention Deficit Hyperactivity Disorder (ADHD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Virginia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01133028
First received: May 10, 2010
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Behavioral: Behavioral contingency management
Behavioral: Tolerance training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Child Peer Relationships [ Time Frame: The first day of the treatment and the last day of the treatment (two weeks later) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 102
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined
This represents a combination of the tolerance training and behavioral management interventions together.
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.
Active Comparator: Behavioral management
This represents the behavioral contingency management intervention only.
Behavioral: Behavioral contingency management
Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors.

  Eligibility

Ages Eligible for Study:   6 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children ages 6-8
  • Primary diagnosis of ADHD

Exclusion Criteria:

  • Pervasive Developmental Disorder
  • Verbal IQ below 75
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Amori Y Mikami, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01133028     History of Changes
Other Study ID Numbers: 2010-0066-00
Study First Received: May 10, 2010
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Attention Deficit Hyperactivity Disorder (ADHD)

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014