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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Training Executive, Attention and Motor Skills (TEAMS)
* Behavioral: Parent support and education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 48 Months
Maximum Age: 71 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive enhancing games<br>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)<br>* Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home<br>|
| Active Comparator: Parent support and education<br>Parents will participate in groups designed to provide information about ADHD and support for working with their child. | Behavioral: Parent support and education<br>* Parents will participate in groups designed to provide information about ADHD and support for working with their child.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment | These are parent and teacher ratings of ADHD symptoms | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Preschool Children, Treatment, Non-pharmacological