Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Home-Based Parent Training in ADHD Preschoolers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320098
• Other study ID #: 5R01MH074556-04
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: December 5, 2014
• Start date: January 2007
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 4 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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. 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. Increasing the quality and quantity of positive interactions between you and your child Changing the way you respond to your child's inappropriate behaviors so as to reduce the frequency of negative interactions. 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.
• 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: Increasing the positive attention you give to your child. Reducing the inappropriate use of commands, questions and criticisms. Appropriate use of praise and physical attention (e.g., hugs) as rewards. 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
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.

Locations

Country	Name	City	State
United States	NYU Child Study Center, One Park Avenue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conners Teacher Rating Scale	Behavior Rating Scale	Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)	No
Secondary	Conners Parent Rating Scale	Behavior Rating Scale	Post-Treatment (within one week of the last treatment session / end of the 8 week waiting period)	No

External Links

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