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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Behavioral: Incredible Years Program

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 Type: Interventional
• Enrollment (Actual): 345
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parenting behavior	Measured post-intervention and at 6- and 12-month follow-ups
Child disruptive behaviors	Measured post-intervention and at 6- and 12-month follow-ups

Secondary Outcome Measures

Outcome Measure	Time Frame
Child and parent functional status/impairment	Measured post-intervention and at 6- and 12-month follow-ups
Parenting stress	Measured post-intervention and at 6- and 12-month follow-ups
Family functioning	Measured post-intervention and at 6- and 12-month follow-ups
Consumer perspectives	Measured post-intervention and at 6- and 12-month follow-ups
Cost of services	Measured post-intervention and at 6- and 12-month follow-ups
Barriers to treatment	Measured post-intervention and at 6- and 12-month follow-ups

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: National Institute of Mental Health (NIMH)
• 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 20, 2006
• First Submitted That Met QC Criteria: November 20, 2006
• First Posted (Estimate): November 22, 2006

Study Record Updates

• Last Update Posted (Estimate): February 12, 2013
• Last Update Submitted That Met QC Criteria: February 11, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Primary Health Care; Pediatrics; Child, Preschool; Parenting Education; Oppositional Defiant Disorder; Preventive Intervention; Attention Deficit Disorders; Disruptive Behavior Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Neurodevelopmental Disorders; Disease; Problem Behavior; Mental Disorders; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: R01MH076244 (U.S. NIH Grant/Contract); DSIR CT-C