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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Advanced Parenting Education in Pediatrics: The APEP Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402857
• Other study ID #: R01MH076244
• Secondary ID: R01MH076244DSIR
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2006
• Last updated: February 11, 2013
• Start date: November 2006
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Months to 38 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder With Hyperactivity
• Disease
• Mental Disorders

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.

Locations

Country	Name	City	State
United States	MGH Chelsea Healthcare Center	Chelsea	Massachusetts
United States	Codman Square Health Center	Dorchester	Massachusetts
United States	Martha Eliot Health Center	Jamaica Plain	Massachusetts
United States	Medical Associates Pediatrics	Leominster	Massachusetts
United States	Southboro Medical Group	Southboro	Massachusetts
United States	Pediatrics West	Westford	Massachusetts
United States	Westwood-Mansfield Pediatric Associates	Westwood	Massachusetts
United States	Wilmington Pediatrics	Wilmington	Massachusetts
United States	Woburn Pediatric Associates	Woburn	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting behavior		Measured post-intervention and at 6- and 12-month follow-ups	No
Primary	Child disruptive behaviors		Measured post-intervention and at 6- and 12-month follow-ups	No
Secondary	Child and parent functional status/impairment		Measured post-intervention and at 6- and 12-month follow-ups	No
Secondary	Parenting stress		Measured post-intervention and at 6- and 12-month follow-ups	No
Secondary	Family functioning		Measured post-intervention and at 6- and 12-month follow-ups	No
Secondary	Consumer perspectives		Measured post-intervention and at 6- and 12-month follow-ups	No
Secondary	Cost of services		Measured post-intervention and at 6- and 12-month follow-ups	No
Secondary	Barriers to treatment		Measured post-intervention and at 6- and 12-month follow-ups	No