Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders |
Behavioral: Incredible Years Program |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Advanced Parenting Education in Pediatrics: The APEP Project |
- 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 ]
- 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 ]
| Enrollment: | 345 |
| Study Start Date: | November 2006 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive the Incredible Years Program, a group parenting 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.
|
|
2
Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 22 Months to 38 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Massachusetts | |
| MGH Chelsea Healthcare Center | |
| Chelsea, Massachusetts, United States | |
| Codman Square Health Center | |
| Dorchester, Massachusetts, United States, 02124 | |
| Martha Eliot Health Center | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| Medical Associates Pediatrics | |
| Leominster, Massachusetts, United States, 01453 | |
| Southboro Medical Group | |
| Southboro, Massachusetts, United States, 01772 | |
| Pediatrics West | |
| Westford, Massachusetts, United States, 01886 | |
| Westwood-Mansfield Pediatric Associates | |
| Westwood, Massachusetts, United States, 02090 | |
| Wilmington Pediatrics | |
| Wilmington, Massachusetts, United States, 01887 | |
| Woburn Pediatric Associates | |
| Woburn, Massachusetts, United States, 01801 | |
| Principal Investigator: | Ellen C. Perrin, MD | Tufts Medical Center |
| Principal Investigator: | Christopher Sheldrick, PhD | Tufts Medical Center |
| Principal Investigator: | Jannette McMenamy, PhD | Fitchburg State College |
More Information
No publications provided
| Responsible Party: | Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT00402857 History of Changes |
| Other Study ID Numbers: | R01 MH076244, R01MH076244, DSIR CT-C |
| Study First Received: | November 20, 2006 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Tufts Medical Center:
|
Parenting Education Child, Preschool Preventive Intervention Primary Health Care |
Pediatrics Attention Deficit Disorders Oppositional Defiant Disorder Disruptive Behavior Disorder |
Additional relevant MeSH terms:
|
Mental Disorders Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder with Hyperactivity Hyperkinesis Mental Disorders Diagnosed in Childhood |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013