Brain Training in Children With/At-risk for Attention-Deficit/Hyperactivity Disorder and Executive Function Impairment

Study Overview
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Brief Summary
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The purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games (brain training) targeting executive function (EF) skills (i.e., thinking, problem-solving) result in improvements in EF in preschool children with or at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) and EF problems. The investigators hypothesize that children receiving active brain training will show greater improvements in EF and related skills immediately after treatment than children receiving passive brain training. The investigators are also interested in whether any improvements in EF and related skills occur or are maintained at 3 and 6 months after completion of brain training.

Detailed Description
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Investigators will talk to you by telephone to determine if your child might be eligible for the study. Children complete two baseline testing sessions to evaluate executive function (EF) and related skills Parents complete a packet of information, including questionnaires about the child's behavior, EF, and functional skills. After completion of the baseline testing, we will inform you of eligibility for the Brain Training phase. During Brain Training children play online computer games for 25-30 minutes/day (can range from 15-45 minutes/day depending on your child's attention, training version received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete a total of 25 sessions. Children return for 3 more time points, immediately after the completion of Brain Training (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after completion of Brain Training.

Official Title
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Randomized Controlled Trial of Executive Function Training in Children With or At-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) and Executive Function (EF) Impairment

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Brain Training (Active)
* Behavioral: Brain Training (Passive)
* Behavioral: Brain Training (Active or Passive)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 4 or 5 years Born Full term (37 weeks gestation or greater) Diagnosis of ADHD or high ADHD symptoms (T-score 60 or greater on standardized behavior questionnaire) Able to comprehend task instructions Exclusion Criteria: Major neurosensory impairment (ie blind, deaf) that interferes with testing Genetic syndrome Inability to comprehend task instructions

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain Training (Active)<br>The children in this arm receive one type of Brain Training with online computer games that actively matches their skill level. | Behavioral: Brain Training (Active)<br>* Online computer games targeting attention, EF, and problem-solving<br>|
| Experimental: Brain Training (Passive)<br>The children in this arm receive one type of Brain Training with online computer games that are at a consistent level. | Behavioral: Brain Training (Passive)<br>* Online computer games targeting attention, EF, and problem solving<br>|
| Experimental: Cross-over<br>Following completion of the 6-month follow-up sessions after completion of Brain Training, each group is allowed to cross-over to the other arm of Brain Training (open-label extension). | Behavioral: Brain Training (Active or Passive)<br>* Online computer games targeting attention, EF, and problem solving<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change fro baseline on Executive Function Composite Measure at 2 months | EF composite measured post Brain Training | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on Executive Function Composite measure at 5 months | EF composite measured 3-months post Brain Training and 5 months from baseline | 5 months | 
| Change from baseline on Executive Function Composite measure at 8 months | EF composite measured 6-months post Brain Training and 8 months from baseline | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder; executive function; preschool