Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

— NIPA  

Official title:

Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462032
• Other study ID #: 4R33MH085898-03
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2011
• Last updated: June 3, 2014
• Start date: April 2011
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: Queens College, The City University of New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate two potential treatments for children with Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication. Our goal is to develop new interventions for preschoolers with ADHD that will result in enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent long-term difficulties characteristic of many children with ADHD.

Both interventions involve weekly playgroups (of roughly five children) in which children engage in designated activities while parents engage in groups focusing on parent education, support, and their children's activities. It is hypothesized that both interventions will be helpful, but that only one will have lasting effects well beyond the end of active treatment.

Description:

Children eligible for this study are:

• 4 and 5 years-old (between the ages of 48 - 72 months)

• shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. To enter the study, following our evaluation, they will need to meet diagnostic criteria for ADHD

• enrolled in a preschool or daycare setting

Children are ineligible to participate in this study if they:

• are currently being treated with psychotropic medication

• have a diagnosed neurological disorder

• have an autism spectrum pr pervasive developmental disorder

• are intellectually impaired

• are highly physically aggressive

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 48 Months to 71 Months

Eligibility

Inclusion Criteria:

• Child is hyperactive

• Child meets criteria for ADHD

• Child attends preschool or kindergarten

• Family speaks English at home

Exclusion Criteria:

• Family does not speak English at home

• Child does not attend preschool/kindergarten

• Child is diagnosed with or suspected of having PDD

• Child has IQ of less than 80

• Child is being treated with psychotropic medication

• Child has a diagnosed neurological disorder

• Child is aggressive

• Child is only inattentive and does not exhibit signs of hyperactivity

• Parent has attended parent management classes

• Child is not physically able to participate in group play sessions

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Training Executive, Attention and Motor Skills (TEAMS)
Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home
• Parent support and education
Parents will participate in groups designed to provide information about ADHD and support for working with their child.

Locations

Country	Name	City	State
United States	Queens College, City University of New York	Flushing	New York

Sponsors (1)

Lead Sponsor	Collaborator
Queens College, The City University of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment	This is a clinical rating based on data derived from parent and teacher ratings as well as a semi-structured clinical interview with the child's caretaker.	Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)	No
Secondary	Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment	These are parent and teacher ratings of ADHD symptoms	Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)	No

External Links

•   NIPA Website