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

Stanford University

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Behavioral: Brain Training (Active); Behavioral: Brain Training (Active or Passive); Behavioral: Brain Training (Passive)

Study type: Interventional

Funder types: Other

Identifiers

NCT02588365

30874-2

Details and patient eligibility

About

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.

Full 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."

Enrollment: 34 patients

Sex: All

Ages: 4 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 3 patient groups

Brain Training (Active)

Experimental group

Description:

The children in this arm receive one type of "Brain Training" with online computer games that actively matches their skill level.

Treatment:

Behavioral: Brain Training (Active)

Brain Training (Passive)

Experimental group

Description:

The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent level.

Treatment:

Behavioral: Brain Training (Passive)

Cross-over

Experimental group

Description:

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).

Treatment:

Behavioral: Brain Training (Active or Passive)