NCT01320098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

7.8 years

First QC Date

March 11, 2011

Last Update Submit

December 5, 2014

Conditions

Keywords

AttentionBehavior ProblemsComplianceEvaluationPreschoolADHDOveractiveInattentiveAttention Deficit Hyperactivity Disorder in Preschoolers

Outcome Measures

Primary Outcomes (1)

  • Conners Teacher Rating Scale

    Behavior Rating Scale

    Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)

Secondary Outcomes (1)

  • Conners Parent Rating Scale

    Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)

Study Arms (3)

Home-Based Parenting Program

EXPERIMENTAL
Behavioral: Home-Based Parenting Program

Clinic-Based Parenting Program

EXPERIMENTAL
Behavioral: Clinic-Based Parenting Program

Wait-List Control Group

OTHER
Behavioral: Wait-List Control Group

Interventions

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.

Home-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.

Clinic-Based Parenting Program

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.

Wait-List Control Group

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Child Study Center, One Park Avenue

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMental DisordersPatient Compliance

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Howard Abikoff, Ph.D.

    New York University Child Study Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 22, 2011

Study Start

January 1, 2007

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations