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Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00402857
First received: November 20, 2006
Last updated: February 11, 2013
Last verified: February 2013

November 20, 2006
February 11, 2013
November 2006
December 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
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Attention Deficit Disorder With Hyperactivity
  • Attention Deficit and Disruptive Behavior Disorders
Behavioral: Incredible Years Program
The Incredible Years Program is a 10-week group parenting intervention. 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.
  • Experimental: 1
    Participants will receive the Incredible Years Program, a group parenting intervention
    Intervention: Behavioral: Incredible Years Program
  • 2
    Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period
    Intervention: Behavioral: Incredible Years Program
Perrin EC, Sheldrick RC, McMenamy JM, Henson BS, Carter AS. Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial. JAMA Pediatr. 2014 Jan;168(1):16-24. doi: 10.1001/jamapediatrics.2013.2919.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
December 2011
December 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 information is only displayed when the study is recruiting subjects
United States
 
NCT00402857
R01 MH076244, R01MH076244, DSIR CT-C
No
Tufts Medical Center
Tufts Medical Center
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
Tufts Medical Center
February 2013

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