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Preventing Behavior Problems in Children With ADHD

L

Lehigh University

Status and phase

Unknown
Phase 2

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Behavioral: Community Intervention
Behavioral: Multi-Setting Early Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00057668
R01MH061563 (U.S. NIH Grant/Contract)
DSIR CT-S

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

3 to 5 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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