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

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00402857
  Purpose

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.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Behavioral: Incredible Years Program
Phase III

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder    Children's Health    Parenting   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Advanced Parenting Education in Pediatrics: The APEP Project

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment:   352
Study Start Date:   November 2006
Estimated Primary Completion Date:   August 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Participants will receive the Incredible Years Program, a group parenting intervention
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.
2
Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period
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.

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.

  Eligibility
Ages Eligible for Study:   22 Months to 38 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402857

Contacts
Contact: Chris Sheldrick, PhD     617-636-4830     rsheldrick@tuftsmedicalcenter.org    

Locations
United States, Massachusetts
Medical Associates Pediatrics     Recruiting
      Leominster, Massachusetts, United States, 01453
Codman Square Health Center     Recruiting
      Dorchester, Massachusetts, United States, 02124
Martha Eliot Health Center     Completed
      Jamaica Plain, Massachusetts, United States, 02130
Southboro Medical Group     Recruiting
      Southboro, Massachusetts, United States, 01772
Wilmington Pediatrics     Recruiting
      Wilmington, Massachusetts, United States, 01887
Woburn Pediatric Associates     Recruiting
      Woburn, Massachusetts, United States, 01801
Pediatrics West     Recruiting
      Westford, Massachusetts, United States, 01886
Westwood-Mansfield Pediatric Associates     Recruiting
      Westwood, Massachusetts, United States, 02090

Sponsors and 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    
  More Information


Responsible Party:   Tufts-New England Medical Center ( Ellen C. Perrin, MD, Principal Investigator )
Study ID Numbers:   R01 MH76244, DSIR CT-C
First Received:   November 20, 2006
Last Updated:   August 20, 2008
ClinicalTrials.gov Identifier:   NCT00402857
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Parenting Education  
Child, Preschool  
Preventive Intervention  
Primary Health Care  
Pediatrics
Attention Deficit Disorders
Oppositional Defiant Disorder
Disruptive Behavior Disorder

Study placed in the following topic categories:
Signs and Symptoms
Oppositional defiant disorder
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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