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Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01320098
First received: March 11, 2011
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
 Behavioral: Home-Based Parenting Program
Behavioral: Clinic-Based Parenting Program
Behavioral: Wait-List Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-Based Parent Training in ADHD Preschoolers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Conners Teacher Rating Scale [ Time Frame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period) ] [ Designated as safety issue: No ]
    Behavior Rating Scale


Secondary Outcome Measures:
  • Conners Parent Rating Scale [ Time Frame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period) ] [ Designated as safety issue: No ]
    Behavior Rating Scale


Estimated Enrollment: 187
Study Start Date: January 2007
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home-Based Parenting Program Behavioral: Home-Based Parenting Program

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.

  1. 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.
  2. Increasing the quality and quantity of positive interactions between you and your child
  3. Changing the way you respond to your child's inappropriate behaviors so as to reduce the frequency of negative interactions.
  4. 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.
Experimental: Clinic-Based Parenting Program Behavioral: Clinic-Based Parenting Program

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:

  1. Increasing the positive attention you give to your child.
  2. Reducing the inappropriate use of commands, questions and criticisms.
  3. Appropriate use of praise and physical attention (e.g., hugs) as rewards.
  4. 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.
Wait-List Control Group Behavioral: Wait-List Control Group
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.

  Eligibility

Ages Eligible for Study:   3 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320098

Locations
United States, New York
NYU Child Study Center, One Park Avenue
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Howard Abikoff, Ph.D. New York University Child Study Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01320098     History of Changes
Other Study ID Numbers: 5 R01 MH074556-04
Study First Received: March 11, 2011
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Attention
Behavior Problems
Compliance
Evaluation
Preschool
 ADHD
Overactive
Inattentive
Attention Deficit Hyperactivity Disorder in Preschoolers

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013