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

Queens College, The City University of New York

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Behavioral: Parent support and education; Behavioral: Training Executive, Attention and Motor Skills (TEAMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01462032

4R33MH085898-03

Details and patient eligibility

About

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.

Full 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

Enrollment: 52 patients

Sex: All

Ages: 48 to 71 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

Cognitive enhancing games

Experimental group

Description:

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

Treatment:

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

Parent support and education

Active Comparator group

Description:

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

Treatment:

Behavioral: Parent support and education