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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary:

  • 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."

Sponsor: Stanford University

Current Primary Outcome: Change fro baseline on Executive Function Composite Measure at 2 months [ Time Frame: 2 months ]

EF composite measured post "Brain Training"


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: October 26, 2015
Date Started: October 2015
Date Completion: December 2018
Last Updated: October 26, 2016
Last Verified: October 2016