search
Back to results

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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral contingency management
Tolerance training
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children ages 6-8
  • Primary diagnosis of ADHD

Exclusion Criteria:

  • Pervasive Developmental Disorder
  • Verbal IQ below 75

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined

Behavioral management

Arm Description

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

This represents the behavioral contingency management intervention only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2010
Last Updated
May 26, 2010
Sponsor
University of Virginia
search

1. Study Identification

Unique Protocol Identification Number
NCT01133028
Brief Title
Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder (ADHD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined
Arm Type
Experimental
Arm Description
This represents a combination of the tolerance training and behavioral management interventions together.
Arm Title
Behavioral management
Arm Type
Active Comparator
Arm Description
This represents the behavioral contingency management intervention only.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral contingency management
Intervention Description
Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Tolerance training
Intervention Description
Teachers will be instructed in procedures to encourage the peer group to be accepting of children with ADHD.
Primary Outcome Measure Information:
Title
Child Peer Relationships
Description
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 Outcome Measure Information:
Title
Child Behavior Problems
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children ages 6-8 Primary diagnosis of ADHD Exclusion Criteria: Pervasive Developmental Disorder Verbal IQ below 75
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amori Y Mikami, PhD
Phone
4342432327
Email
mikami@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amori Y Mikami, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amori Y Mikami, PhD
Phone
434-243-2327
Email
mikami@virginia.edu
First Name & Middle Initial & Last Name & Degree
Amori Y Mikami, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs