Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00402857 |
Recruitment Status :
Completed
First Posted : November 22, 2006
Last Update Posted : February 12, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders | Behavioral: Incredible Years Program | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 345 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Advanced Parenting Education in Pediatrics: The APEP Project |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
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. |
- Parenting behavior [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ]
- Child disruptive behaviors [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ]
- Child and parent functional status/impairment [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ]
- Parenting stress [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ]
- Family functioning [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ]
- Consumer perspectives [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ]
- Cost of services [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ]
- Barriers to treatment [ Time Frame: Measured post-intervention and at 6- and 12-month follow-ups ]

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Ages Eligible for Study: | 22 Months to 38 Months (Child) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402857
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 |
Responsible Party: | Tufts Medical Center |
ClinicalTrials.gov Identifier: | NCT00402857 |
Other Study ID Numbers: |
R01MH076244 ( U.S. NIH Grant/Contract ) R01MH076244 ( U.S. NIH Grant/Contract ) DSIR CT-C |
First Posted: | November 22, 2006 Key Record Dates |
Last Update Posted: | February 12, 2013 |
Last Verified: | February 2013 |
Parenting Education Child, Preschool Preventive Intervention Primary Health Care |
Pediatrics Attention Deficit Disorders Oppositional Defiant Disorder Disruptive Behavior Disorder |
Disease Attention Deficit Disorder with Hyperactivity Mental Disorders Problem Behavior |
Attention Deficit and Disruptive Behavior Disorders Pathologic Processes Neurodevelopmental Disorders Behavioral Symptoms |