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

Tracking Information

First Received Date ^ICMJE

March 11, 2011

Last Updated Date

June 29, 2012

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01320098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers

Official Title ^ICMJE

Home-Based Parent Training in ADHD Preschoolers

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Attention Deficit Hyperactivity Disorder

Intervention ^ICMJE

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.
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.
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.

Study Arm (s)

Experimental: Home-Based Parenting Program
Intervention: Behavioral: Home-Based Parenting Program
Experimental: Clinic-Based Parenting Program
Intervention: Behavioral: Clinic-Based Parenting Program
Wait-List Control Group
Intervention: Behavioral: Wait-List Control Group

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

187

Estimated Completion Date

November 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Years to 4 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01320098

Other Study ID Numbers ^ICMJE

5 R01 MH074556-04

Has Data Monitoring Committee

Responsible Party

New York University School of Medicine

Study Sponsor ^ICMJE

New York University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Howard Abikoff, Ph.D.

New York University Child Study Center

Information Provided By

New York University School of Medicine

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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