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Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
This study is currently recruiting participants.
Study NCT00402857   Information provided by National Institute of Mental Health (NIMH)
First Received: November 20, 2006   Last Updated: March 23, 2009   History of Changes

November 20, 2006
March 23, 2009
November 2006
August 2011   (final data collection date for primary outcome measure)
  • Parenting behavior [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Child disruptive behaviors [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Measured post-intervention and at 6- and 12-month follow-ups: Parenting behavior
  • Child disruptive behaviors
Complete list of historical versions of study NCT00402857 on ClinicalTrials.gov Archive Site
  • Child and parent functional status/impairment [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Parenting stress [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Family functioning [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Consumer perspectives [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Cost of services [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Barriers to treatment [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Measured post-intervention and at 6- and 12-month follow-ups: Child and parent functional status/impairment
  • Parenting stress
  • Family functioning
  • Consumer perspectives
  • Cost of services
  • Barriers to treatment
 
Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
Advanced Parenting Education in Pediatrics: The APEP Project

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.

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.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Attention Deficit Disorder With Hyperactivity
  • Attention Deficit and Disruptive Behavior Disorders
Behavioral: Incredible Years Program
  • Experimental: Participants will receive the Incredible Years Program, a group parenting intervention
  • Other: Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
352
 
August 2011   (final data collection date for primary outcome measure)

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
Both
22 Months to 38 Months
Yes
Contact: Chris Sheldrick, PhD 617-636-4830 rsheldrick@tuftsmedicalcenter.org
United States
 
NCT00402857
Ellen C. Perrin, MD, Principal Investigator, Tufts-New England Medical Center
R01 MH076244, DSIR CT-C
National Institute of Mental Health (NIMH)
 
Principal Investigator: Ellen C. Perrin, MD Tufts Medical Center
Principal Investigator: Christopher Sheldrick, PhD Tufts Medical Center
Principal Investigator: Jannette McMenamy, PhD Fitchburg State College
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP