Clinical trial NCT01462032: Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Preschool Children
ADHD
Treatment
Non-pharmacological
Lead sponsor: Queens College, The City University of New York
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 52
Sex: ALL
Minimum age (years): 48
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment
timeFrame: 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:
measure: Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment
timeFrame: 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)
Other outcomes:
Locations:
city: Flushing
country: United States
facility: Queens College, City University of New York
state: New York
Study officials:
affiliation: Queens College, CUNY
name: Jeffrey M Halperin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.