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| Descriptive Information Fields | |||||||||||||
| Brief Title † | Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders | ||||||||||||
| Official Title † | Advanced Parenting Education in Pediatrics: The APEP Project | ||||||||||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||||||
| Study Type † | Interventional | ||||||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||||||
| Primary Outcome Measure † | Parenting behavior [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ] Child disruptive behaviors [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Child and parent functional status/impairment [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ] Parenting stress [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ] Family functioning [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ] Consumer perspectives [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ] Cost of services [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ] Barriers to treatment [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ] |
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| Condition † | Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders |
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| Intervention † | Behavioral: Incredible Years Program | ||||||||||||
| MEDLINE PMIDs | |||||||||||||
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| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||
| Enrollment † | 352 | ||||||||||||
| Start Date † | November 2006 | ||||||||||||
| Completion Date | |||||||||||||
| Eligibility Criteria † | 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:
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| Gender | Both | ||||||||||||
| Ages | 22 Months to 38 Months | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00402857 | ||||||||||||
| Organization ID | R01 MH76244 | ||||||||||||
| Secondary IDs †† | DSIR CT-C | ||||||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||||||
| Collaborators †† | |||||||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||||||
| Verification Date | August 2008 | ||||||||||||
| First Received Date † | November 20, 2006 | ||||||||||||
| Last Updated Date | August 20, 2008 | ||||||||||||