Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
Primary Purpose
Attention Deficit Disorder With Hyperactivity, Attention Deficit and Disruptive Behavior Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Incredible Years Program
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Parenting Education, Child, Preschool, Preventive Intervention, Primary Health Care, Pediatrics, Attention Deficit Disorders, Oppositional Defiant Disorder, Disruptive Behavior Disorder
Eligibility Criteria
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
Sites / Locations
- MGH Chelsea Healthcare Center
- Codman Square Health Center
- Martha Eliot Health Center
- Medical Associates Pediatrics
- Southboro Medical Group
- Pediatrics West
- Westwood-Mansfield Pediatric Associates
- Wilmington Pediatrics
- Woburn Pediatric Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
Participants will receive the Incredible Years Program, a group parenting intervention
Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period
Outcomes
Primary Outcome Measures
Parenting behavior
Child disruptive behaviors
Secondary Outcome Measures
Child and parent functional status/impairment
Parenting stress
Family functioning
Consumer perspectives
Cost of services
Barriers to treatment
Full Information
NCT ID
NCT00402857
First Posted
November 20, 2006
Last Updated
February 11, 2013
Sponsor
Tufts Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00402857
Brief Title
Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
Official Title
Advanced Parenting Education in Pediatrics: The APEP Project
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Attention Deficit and Disruptive Behavior Disorders
Keywords
Parenting Education, Child, Preschool, Preventive Intervention, Primary Health Care, Pediatrics, Attention Deficit Disorders, Oppositional Defiant Disorder, Disruptive Behavior Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
345 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive the Incredible Years Program, a group parenting intervention
Arm Title
2
Arm Type
Other
Arm Description
Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period
Intervention Type
Behavioral
Intervention Name(s)
Incredible Years Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parenting behavior
Time Frame
Measured post-intervention and at 6- and 12-month follow-ups
Title
Child disruptive behaviors
Time Frame
Measured post-intervention and at 6- and 12-month follow-ups
Secondary Outcome Measure Information:
Title
Child and parent functional status/impairment
Time Frame
Measured post-intervention and at 6- and 12-month follow-ups
Title
Parenting stress
Time Frame
Measured post-intervention and at 6- and 12-month follow-ups
Title
Family functioning
Time Frame
Measured post-intervention and at 6- and 12-month follow-ups
Title
Consumer perspectives
Time Frame
Measured post-intervention and at 6- and 12-month follow-ups
Title
Cost of services
Time Frame
Measured post-intervention and at 6- and 12-month follow-ups
Title
Barriers to treatment
Time Frame
Measured post-intervention and at 6- and 12-month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Months
Maximum Age & Unit of Time
38 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen C. Perrin, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Sheldrick, PhD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jannette McMenamy, PhD
Organizational Affiliation
Fitchburg State College
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Chelsea Healthcare Center
City
Chelsea
State/Province
Massachusetts
Country
United States
Facility Name
Codman Square Health Center
City
Dorchester
State/Province
Massachusetts
ZIP/Postal Code
02124
Country
United States
Facility Name
Martha Eliot Health Center
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Medical Associates Pediatrics
City
Leominster
State/Province
Massachusetts
ZIP/Postal Code
01453
Country
United States
Facility Name
Southboro Medical Group
City
Southboro
State/Province
Massachusetts
ZIP/Postal Code
01772
Country
United States
Facility Name
Pediatrics West
City
Westford
State/Province
Massachusetts
ZIP/Postal Code
01886
Country
United States
Facility Name
Westwood-Mansfield Pediatric Associates
City
Westwood
State/Province
Massachusetts
ZIP/Postal Code
02090
Country
United States
Facility Name
Wilmington Pediatrics
City
Wilmington
State/Province
Massachusetts
ZIP/Postal Code
01887
Country
United States
Facility Name
Woburn Pediatric Associates
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24190691
Citation
Perrin EC, Sheldrick RC, McMenamy JM, Henson BS, Carter AS. Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial. JAMA Pediatr. 2014 Jan;168(1):16-24. doi: 10.1001/jamapediatrics.2013.2919.
Results Reference
derived
Learn more about this trial
Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
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