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

NCT01462032 | Completed Phase 2

• 1 other identifier: 4R33MH085898-03
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Preschool Children; ADHD; Treatment; Non-pharmacological

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

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

  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)

Study Arms (2)

Cognitive enhancing games

EXPERIMENTAL

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

Behavioral: Training Executive, Attention and Motor Skills (TEAMS)

Parent support and education

ACTIVE COMPARATOR

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

Behavioral: Parent support and education

Interventions

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

Cognitive enhancing games

Parent support and education BEHAVIORAL

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

Parent support and education

Eligibility Criteria

• Age: 48 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child is hyperactive
• Child meets criteria for ADHD
• Child attends preschool or kindergarten
• Family speaks English at home

You may not qualify if:

• 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

Sponsors & Collaborators

• Queens College, The City University of New York: lead

Study Sites (1)

Queens College, City University of New York

Flushing, New York, 11367, United States

Location

Related Publications (1)

• 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.

  PMID: 31834588 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Jeffrey M Halperin, Ph.D.

  Queens College, CUNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Psychology

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: October 28, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)