CClinicalTrials.gg
Status unknownNCT00057668Updated Nov 19, 2013

Preventing Behavior Problems in Children With ADHD

A Phase 2 interventional study of Multi-Setting Early Intervention and Community Intervention in Attention Deficit Disorder With Hyperactivity, sponsored by Lehigh University. Status unknown at 1 site in United States. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-19.

Sponsored by Lehigh University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
3 Years to 5 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Attention Deficit Disorder With Hyperactivity
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's enrollment of 200 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Lehigh University is the lead sponsor of 16 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants

Interventions

  • BehavioralMulti-Setting Early Intervention
  • BehavioralCommunity Intervention
06

Study locations

1 site
  • Lehigh University College of Education
    Bethlehem, Pennsylvania 18015, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00057668
Lead sponsor
Lehigh University
Collaborators
National Institute of Mental Health (NIMH)
First posted
Apr 8, 2003
Start date
Sep 2001
Completion
Aug 2006
Last update
Nov 19, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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