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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00402857 |
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 |
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Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders |
Behavioral: Incredible Years Program |
Phase III |
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 |
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 |
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1: Experimental
Participants will receive the Incredible Years Program, a group parenting intervention
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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.
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2
Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period
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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.
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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.
Ages Eligible for Study: | 22 Months to 38 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Parent or primary caregiver of a child who fits the following criteria:
Exclusion Criteria:
Parent or primary caregiver of a child who fits the following criteria:
Contact: Chris Sheldrick, PhD | 617-636-4830 | rsheldrick@tuftsmedicalcenter.org |
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 |
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 |
Responsible Party: | Tufts-New England Medical Center ( Ellen C. Perrin, MD, Principal Investigator ) |
Study ID Numbers: | R01 MH76244, DSIR CT-C |
Study First Received: | November 20, 2006 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00402857 |
Health Authority: | United States: Federal Government |
Parenting Education Child, Preschool Preventive Intervention Primary Health Care |
Pediatrics Attention Deficit Disorders Oppositional Defiant Disorder Disruptive Behavior Disorder |
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 |
Pathologic Processes Disease Nervous System Diseases |