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

NCT ID: NCT01462032

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-03-31

Brief 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.

Detailed 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

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cognitive enhancing games

Children will be introduced to specific games believed to enhance cognitive functioning. Parent will be encouraged to play these games with their children.

Group Type: EXPERIMENTAL

Training Executive, Attention and Motor Skills (TEAMS)

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Parent support and education

Intervention Type: BEHAVIORAL

Parents will participate in groups designed to provide information about ADHD and support for working with their child.

Interventions

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

Intervention Type: BEHAVIORAL

Parent support and education

Parents will participate in groups designed to provide information about ADHD and support for working with their child.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 48 Months
• Maximum Eligible Age: 71 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queens College, The City University of New York

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Halperin

Distinguished Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey M Halperin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Queens College, CUNY

Locations

Queens College, City University of New York

Flushing, New York, United States

Countries

United States

References

Halperin JM, Marks DJ, Chacko A, Bedard AC, O'Neill S, Curchack-Lichtin J, Bourchtein E, Berwid OG. Training Executive, Attention, and Motor Skills (TEAMS): a Preliminary Randomized Clinical Trial of Preschool Youth with ADHD. J Abnorm Child Psychol. 2020 Mar;48(3):375-389. doi: 10.1007/s10802-019-00610-w.

Reference Type: DERIVED

PMID: 31834588 (View on PubMed)

Other Identifiers

4R33MH085898-03

Identifier Type: NIH

Identifier Source: org_study_id

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