CClinicalTrials.gg
Status unknownNCT01133028Updated May 28, 2010

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

An interventional study of Behavioral contingency management and Tolerance training in Attention Deficit Hyperactivity Disorder, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-28.

Sponsored by University of Virginia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • Attention Deficit Hyperactivity Disorder (ADHD)
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's planned enrollment of 102 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Children ages 6-8
  • Primary diagnosis of ADHD

Exclusion criteria

Exclusion Criteria:

  • Pervasive Developmental Disorder
  • Verbal IQ below 75
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Combined

    This represents a combination of the tolerance training and behavioral management interventions together.

    Behavioral: Behavioral contingency management · Behavioral: Tolerance training

  • Active comparator
    Behavioral management

    This represents the behavioral contingency management intervention only.

    Behavioral: Behavioral contingency management

Interventions

  • BehavioralBehavioral contingency management

    Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors.

  • BehavioralTolerance training

    Teachers will be instructed in procedures to encourage the peer group to be accepting of children with ADHD.

06

What researchers measure

Primary outcomes

  1. Child Peer Relationships

    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.

    Time frame: The first day of the treatment and the last day of the treatment (two weeks later)

Secondary outcomes

  1. Child Behavior Problems

    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.

    Time frame: The first day of the treatment and the last day of the treatment (two weeks later)

07

Study locations

1 site
  • University of Virginia
    Charlottesville, Virginia 22904, United States
    • Amori Y Mikami, PhD · Contact · mikami@virginia.edu · 434-243-2327
    • Amori Y Mikami, PhD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01133028
Lead sponsor
University of Virginia
First posted
May 28, 2010
Start date
Jan 2011
Primary completion
Sep 2011 (estimated)
Completion
Jun 2012 (estimated)
Last update
May 28, 2010

Study contacts

Amori Y Mikami, PhD
Contact
mikami@virginia.edu
4342432327
Amori Y Mikami, PhD
principal investigator · University of Virginia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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