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

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: Brain Training (Active); Behavioral: Brain Training (Passive); Behavioral: Brain Training (Active or Passive)

• Registration Number: NCT02588365
• Lead Sponsor: Stanford University

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 Description

* 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."

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Primary Completion: 2018-12
• Study Completion: 2018-12-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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Exclusion Criteria

• Major neurosensory impairment (ie blind, deaf) that interferes with testing
• Genetic syndrome
• Inability to comprehend task instructions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Brain Training (Active)	Brain Training (Active)	The children in this arm receive one type of "Brain Training" with online computer games that actively matches their skill level.
Brain Training (Passive)	Brain Training (Passive)	The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent level.
Cross-over	Brain Training (Active or Passive)	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).

Primary Outcome Measures

Name	Time	Method
Change fro baseline on Executive Function Composite Measure at 2 months	2 months	EF composite measured post "Brain Training"

Secondary Outcome Measures

Name	Time	Method
Change from baseline on Executive Function Composite measure at 5 months	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	8 months	EF composite measured 6-months post "Brain Training" and 8 months from baseline

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States