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Clinical Trials/NCT00402857
NCT00402857
Completed
Phase 3

Advanced Parenting Education in Pediatrics: The APEP Project

Tufts Medical Center9 sites in 1 country345 target enrollmentNovember 2006

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
Tufts Medical Center
Enrollment
345
Locations
9
Primary Endpoint
Parenting behavior
Status
Completed
Last Updated
13 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
December 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parent or primary caregiver of a child who fits the following criteria:
  • Receives a positive result on behavioral screening

Exclusion Criteria

  • Parent or primary caregiver of a child who fits the following criteria:
  • Diagnosis of pervasive developmental disorder or global developmental delay

Outcomes

Primary Outcomes

Parenting behavior

Time Frame: Measured post-intervention and at 6- and 12-month follow-ups

Child disruptive behaviors

Time Frame: Measured post-intervention and at 6- and 12-month follow-ups

Secondary Outcomes

  • Child and parent functional status/impairment(Measured post-intervention and at 6- and 12-month follow-ups)
  • Parenting stress(Measured post-intervention and at 6- and 12-month follow-ups)
  • Family functioning(Measured post-intervention and at 6- and 12-month follow-ups)
  • Consumer perspectives(Measured post-intervention and at 6- and 12-month follow-ups)
  • Cost of services(Measured post-intervention and at 6- and 12-month follow-ups)
  • Barriers to treatment(Measured post-intervention and at 6- and 12-month follow-ups)

Study Sites (9)

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