- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01320098
Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers
Home-Based Parent Training in ADHD Preschoolers
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- NYU Child Study Center, One Park Avenue
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Home-Based Parenting Program
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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.
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Experimental: Clinic-Based Parenting Program
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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:
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Other: Wait-List Control Group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Conners Teacher Rating Scale
Time Frame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
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Behavior Rating Scale
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Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conners Parent Rating Scale
Time Frame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
|
Behavior Rating Scale
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Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Howard Abikoff, Ph.D., New York University Child Study Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01MH074556-04 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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