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

This study is currently recruiting participants.
Study NCT00402857.   Last updated on August 20, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
Official Title  Advanced Parenting Education in Pediatrics: The APEP Project
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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 ]
Secondary Outcome Measure  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 ]
Condition  Attention Deficit Disorder With Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Intervention  Behavioral: Incredible Years Program
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  352
Start Date  November 2006
Completion Date
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
Gender Both
Ages 22 Months to 38 Months
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Chris Sheldrick, PhD     617-636-4830     rsheldrick@tuftsmedicalcenter.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00402857
Organization ID R01 MH76244
Secondary IDs †† DSIR CT-C
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
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    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  November 20, 2006
Last Updated Date August 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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