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Clinical Trial Summary

This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.


Clinical Trial Description

Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) are common childhood behavior disorders. Children with ADHD experience hyperactivity, distractibility, poor concentration, and impulsivity. If left untreated, ADHD can continue into adulthood, and can cause problems in family, social, and work environments. Children with ODD exhibit an ongoing pattern of uncooperative, defiant, and hostile behavior toward authority figures. Symptoms of ODD, including frequent temper tantrums, anger, resentment, and vindictiveness, may interfere with a child's everyday functioning. The Incredible Years parent training program has been shown to be effective in multiple settings at training parents to manage their child's behavior. This study will evaluate the effectiveness of the Incredible Years training program within a pediatric office setting at improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.

Participants in this open-label study will be randomly assigned to the Incredible Years training program or a waitlist condition, in which they will begin the program after a 1-year waiting period. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs. Self-report assessments and phone interviews will be used to assess outcomes. Additionally, follow-up visits will occur immediately post-intervention and 6 and 12 months post-intervention. Children will attend one visit before the program begins, as well as the follow-ups held immediately post-intervention and 12 months post-intervention. These visits will include videotaped observations of children and their primary caregivers. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit and Disruptive Behavior Disorders
  • Attention Deficit Disorder With Hyperactivity
  • Disease
  • Mental Disorders

NCT number NCT00402857
Study type Interventional
Source Tufts Medical Center
Contact
Status Completed
Phase Phase 3
Start date November 2006
Completion date December 2011

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