Viewing Study NCT00402857



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00402857
Status: COMPLETED
Last Update Posted: 2013-02-12
First Post: 2006-11-20

Brief Title: Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
Sponsor: Tufts Medical Center
Organization: Tufts Medical Center

Study Overview

Official Title: Advanced Parenting Education in Pediatrics The APEP Project
Status: COMPLETED
Status Verified Date: 2013-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 childs everyday functioning The Incredible Years parent training program has been shown to be effective in multiple settings at training parents to manage their childs 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DSIR CT-C US NIH GrantContract None httpsreporternihgovquickSearchR01MH076244
R01MH076244 NIH None None