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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Advanced Parenting Education in Pediatrics: The APEP Project

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

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 ]

Enrollment: 345
Study Start Date: November 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Tufts Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00402857     History of Changes
Other Study ID Numbers: R01 MH076244, R01MH076244, DSIR CT-C
Study First Received: November 20, 2006
Last Updated: February 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Tufts Medical Center:
Parenting Education
Child, Preschool
Preventive Intervention
Primary Health Care
Pediatrics
Attention Deficit Disorders
Oppositional Defiant Disorder
Disruptive Behavior Disorder

Additional relevant MeSH terms:
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014