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Completed

NCT Number: NCT02588365

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

  • 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."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Training (Active)

Behavioral

Online computer games targeting attention, EF, and problem-solving

Brain Training (Passive)

Behavioral

Online computer games targeting attention, EF, and problem solving

Brain Training (Active or Passive)

Behavioral

Online computer games targeting attention, EF, and problem solving

Primary outcomes

  1. Change fro baseline on Executive Function Composite Measure at 2 months

    Time frame: 2 months

    EF composite measured post "Brain Training"

Secondary outcomes

  1. Change from baseline on Executive Function Composite measure at 5 months

    Time frame: 5 months

    EF composite measured 3-months post "Brain Training" and 5 months from baseline

  2. Change from baseline on Executive Function Composite measure at 8 months

    Time frame: 8 months

    EF composite measured 6-months post "Brain Training" and 8 months from baseline

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2015
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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