Clinical trial NCT01320098: Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers
Official title: Home-Based Parent Training in ADHD Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention
Behavior Problems
Compliance
Evaluation
Preschool
ADHD
Overactive
Inattentive
Attention Deficit Hyperactivity Disorder in Preschoolers
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 187
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Conners Teacher Rating Scale
timeFrame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
Secondary outcomes:
measure: Conners Parent Rating Scale
timeFrame: Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Child Study Center, One Park Avenue
state: New York
Study officials:
affiliation: New York University Child Study Center
name: Howard Abikoff, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.