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Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-Based Parenting Program
Clinic-Based Parenting Program
Wait-List Control Group
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention, Behavior Problems, Compliance, Evaluation, Preschool, ADHD, Overactive, Inattentive, Attention Deficit Hyperactivity Disorder in Preschoolers

Eligibility Criteria

3 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age = 3.0 - 4.11
  • In preschool program at least 2 half days per week
  • Meets criteria for ADHD on clinical evaluation / DISC
  • ADHD severity: > 1.5 SD above mean for age/sex on CTRS-R
  • ADHD severity: > 1.0 SD above mean for age/sex on CPRS-R

Exclusion Criteria:

  • Current Medication treatment for ADHD
  • IQ < 70 (Full Scale on WPPSI III)
  • Pervasive Developmental Disorder
  • Psychosis
  • Severe receptive language impairment
  • Neurological Disorder
  • Significant medical disorder
  • Primary caretaker is not able to participate
  • Non-English speaking primary care taker

Sites / Locations

  • NYU Child Study Center, One Park Avenue

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Home-Based Parenting Program

Clinic-Based Parenting Program

Wait-List Control Group

Arm Description

Outcomes

Primary Outcome Measures

Conners Teacher Rating Scale
Behavior Rating Scale

Secondary Outcome Measures

Conners Parent Rating Scale
Behavior Rating Scale

Full Information

First Posted
March 11, 2011
Last Updated
December 5, 2014
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT01320098
Brief Title
Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers
Official Title
Home-Based Parent Training in ADHD Preschoolers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to evaluate and compare the effectiveness of two parenting programs in reducing the ADHD symptoms and behavioral problems of preschool children with ADHD through a controlled study. One program is a home-based parent training intervention that is designed to enhance the parent-child interaction, constructive parenting skills, and the child's tolerance for delay. The other intervention is a clinic-based parent training program that focuses on reducing noncompliance in preschool children and improving parenting skills. Both programs consist of private weekly parenting sessions with Clinical Psychologists - once a week for 8 weeks. The sessions are 1-1.5 hours in length. Both programs use behavior modification as a means of improving oppositional and non-compliant child behavior. Both interventions also involve procedures that focus on improving children's attention. Neither program involves medication, and all families will receive one of the two parenting programs being evaluated. Study evaluations, as well as participation in the parenting programs, are provided at no cost to families. Evaluation and parenting sessions can be scheduled at times convenient to families.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention, Behavior Problems, Compliance, Evaluation, Preschool, ADHD, Overactive, Inattentive, Attention Deficit Hyperactivity Disorder in Preschoolers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-Based Parenting Program
Arm Type
Experimental
Arm Title
Clinic-Based Parenting Program
Arm Type
Experimental
Arm Title
Wait-List Control Group
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Home-Based Parenting Program
Intervention Description
The Home-Based Parenting Program aims to improve impulsive and oppositional behaviors in 3 and 4 year-olds. The program involves 8 home visits with a therapist. The visits focus on the skills listed below as a means of improving your child's behavior. Helping you set developmentally appropriate goals for your child. One way we do this is by focusing on situations that occur naturally in your home. Another way is by having you engage in activities with your child that focus on improving attention and the ability to delay. Increasing the quality and quantity of positive interactions between you and your child Changing the way you respond to your child's inappropriate behaviors so as to reduce the frequency of negative interactions. Improving your parenting skills. This program also includes between-session "homework tasks" so that you can practice the skills you have learned throughout the week.
Intervention Type
Behavioral
Intervention Name(s)
Clinic-Based Parenting Program
Intervention Description
The Clinic-Based Parenting Program aims to improve ADHD symptoms by reducing noncompliance, which is common in children with ADHD. Parents learn how to help their child attend to and comply with requests and directions so as to improve compliance and attention. The program involves 8 clinic visits with a therapist. Parents learn various parenting skills to help improve their child's behaviors. Parents learn techniques and skills to promote positive interactions with their child, including: Increasing the positive attention you give to your child. Reducing the inappropriate use of commands, questions and criticisms. Appropriate use of praise and physical attention (e.g., hugs) as rewards. Actively ignoring minor, inappropriate behaviors. Parents also learn how to: increase compliance via clear instruction; respond to compliant and noncompliant behaviors; and create and use clear rules about appropriate and inappropriate child behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Wait-List Control Group
Intervention Description
If your child is randomized to the 8-week Wait-List group, you and your child will be asked to attend 2 assessment visits -1 screening/baseline visit and one 8 weeks later. These assessment visits will take place at our clinic. After completing the second assessment, you will receive your choice of either the home-based or clinic-based parenting program.
Primary Outcome Measure Information:
Title
Conners Teacher Rating Scale
Description
Behavior Rating Scale
Time Frame
Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
Secondary Outcome Measure Information:
Title
Conners Parent Rating Scale
Description
Behavior Rating Scale
Time Frame
Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age = 3.0 - 4.11 In preschool program at least 2 half days per week Meets criteria for ADHD on clinical evaluation / DISC ADHD severity: > 1.5 SD above mean for age/sex on CTRS-R ADHD severity: > 1.0 SD above mean for age/sex on CPRS-R Exclusion Criteria: Current Medication treatment for ADHD IQ < 70 (Full Scale on WPPSI III) Pervasive Developmental Disorder Psychosis Severe receptive language impairment Neurological Disorder Significant medical disorder Primary caretaker is not able to participate Non-English speaking primary care taker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Abikoff, Ph.D.
Organizational Affiliation
New York University Child Study Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Child Study Center, One Park Avenue
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25318650
Citation
Abikoff HB, Thompson M, Laver-Bradbury C, Long N, Forehand RL, Miller Brotman L, Klein RG, Reiss P, Huo L, Sonuga-Barke E. Parent training for preschool ADHD: a randomized controlled trial of specialized and generic programs. J Child Psychol Psychiatry. 2015 Jun;56(6):618-31. doi: 10.1111/jcpp.12346. Epub 2014 Oct 16.
Results Reference
derived
Links:
URL
http://www.aboutourkids.org/research/research_studies/recruiting_studies
Description
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Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers

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