- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057668
Preventing Behavior Problems in Children With ADHD
November 18, 2013 updated by: Lehigh University
Prevention of Behavioral Deficits in Young ADHD Children
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.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- Lehigh University College of Education
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Study Completion
August 1, 2006
Study Registration Dates
First Submitted
April 4, 2003
First Submitted That Met QC Criteria
April 4, 2003
First Posted (Estimate)
April 8, 2003
Study Record Updates
Last Update Posted (Estimate)
November 19, 2013
Last Update Submitted That Met QC Criteria
November 18, 2013
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH061563 (U.S. NIH Grant/Contract)
- DSIR CT-S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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