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Preventing Behavior Problems in Children With ADHD

NCT ID: NCT00057668

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2006-08-31

Brief Summary

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This study will determine the effectiveness of a combination of treatments in preventing behaviors that are typically associated with Attention Deficit Hyperactivity Disorder (ADHD) in young children.

Detailed Description

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Participants are randomly assigned to either a Multi-Setting Early Intervention group or to a Community Intervention group. The Early Intervention group receives parent training and assessment-based behavioral and academic intervention for 1 year, followed by either a high or a low intensity maintenance intervention for an additional 18 months. The Community Intervention group members receive psychotropic medication, special education services, and monthly sessions to obtain information about child development and medical functioning for 2 years. Participants are assessed on six occasions over 4 years. Parents and teachers assess children's behavior, academic performance, and archival data, including medical and school records.

Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Multi-Setting Early Intervention

Intervention Type BEHAVIORAL

Community Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Attention Deficit Hyperactivity Disorder (ADHD) diagnosis
* Preschool, nursery school, or group daycare enrollment at least 2 days per week
* Parents who can communicate in English

Exclusion Criteria

* Plans to move out of the area in the near future
* Mental retardation, neurological damage, significant motor or physical impairments, or autism or other pervasive developmental disorder
* Inattentive ADHD or conduct disorder
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Lehigh University

OTHER

Sponsor Role lead

Locations

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Lehigh University College of Education

Bethlehem, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH061563

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR CT-S

Identifier Type: -

Identifier Source: secondary_id

R01MH061563

Identifier Type: NIH

Identifier Source: org_study_id

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