Clinical trial NCT02588365: Brain Training in Children With/At-risk for Attention-Deficit/Hyperactivity Disorder and Executive Function Impairment
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) Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder; executive function; preschool
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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."

Eligibility criteria: 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

Primary outcomes:
measure: Change fro baseline on Executive Function Composite Measure at 2 months
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline on Executive Function Composite measure at 5 months
timeFrame: 5 months
measure: Change from baseline on Executive Function Composite measure at 8 months
timeFrame: 8 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Irene M Loe, MD
role: PRINCIPAL_INVESTIGATOR
References: