NCT01133028

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 28, 2010

Status Verified

May 1, 2010

Enrollment Period

8 months

First QC Date

May 10, 2010

Last Update Submit

May 26, 2010

Conditions

Keywords

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

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.

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

Secondary Outcomes (1)

  • Child Behavior Problems

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

Study Arms (2)

Combined

EXPERIMENTAL

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

Behavioral: Behavioral contingency managementBehavioral: Tolerance training

Behavioral management

ACTIVE COMPARATOR

This represents the behavioral contingency management intervention only.

Behavioral: Behavioral contingency management

Interventions

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

Behavioral managementCombined

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

Combined

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 6-8
  • Primary diagnosis of ADHD

You may not qualify if:

  • Pervasive Developmental Disorder
  • Verbal IQ below 75

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amori Y Mikami, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amori Y Mikami, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 28, 2010

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

June 1, 2012

Last Updated

May 28, 2010

Record last verified: 2010-05

Locations