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Completed

NCT Number: NCT00402857

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

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.

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Key information

Age range

22 month–38 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MGH Chelsea Healthcare Center, Chelsea, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incredible Years Program

Behavioral

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.

Primary outcomes

  1. Parenting behavior

    Time frame: Measured post-intervention and at 6- and 12-month follow-ups

  2. Child disruptive behaviors

    Time frame: Measured post-intervention and at 6- and 12-month follow-ups

Secondary outcomes

  1. Child and parent functional status/impairment

    Time frame: Measured post-intervention and at 6- and 12-month follow-ups

  2. Parenting stress

    Time frame: Measured post-intervention and at 6- and 12-month follow-ups

  3. Family functioning

    Time frame: Measured post-intervention and at 6- and 12-month follow-ups

  4. Consumer perspectives

    Time frame: Measured post-intervention and at 6- and 12-month follow-ups

  5. Cost of services

    Time frame: Measured post-intervention and at 6- and 12-month follow-ups

  6. Barriers to treatment

    Time frame: Measured post-intervention and at 6- and 12-month follow-ups

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Advanced Parenting Education in Pediatrics: The APEP Project

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2006
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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