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Completed

NCT Number: NCT01462032

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

48 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queens College, City University of New York

Flushing, New York, 11367, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training Executive, Attention and Motor Skills (TEAMS)

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

Behavioral

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

Primary outcomes

  1. Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment

    Time frame: 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)

    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.

Secondary outcomes

  1. Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment

    Time frame: 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)

    These are parent and teacher ratings of ADHD symptoms

Sponsors and collaborators

Lead sponsor

Queens College, The City University of New York

Other

Registry information

Official study title

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

Acronym: NIPA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2011
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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