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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Advanced Parenting Education in Pediatrics: The APEP Project

Conditions
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Attention Deficit Disorder With Hyperactivity, Attention Deficit and Disruptive Behavior Disorders

Intervention / Treatment
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* Behavioral: Incredible Years Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Months
Maximum Age: 38 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive the Incredible Years Program, a group parenting intervention | Behavioral: Incredible Years Program<br>* 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.<br>|
| Other: 2<br>Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period | Behavioral: Incredible Years Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenting Education, Child, Preschool, Preventive Intervention, Primary Health Care, Pediatrics, Attention Deficit Disorders, Oppositional Defiant Disorder, Disruptive Behavior Disorder