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

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588365
• Other study ID #: 30874-2
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 30, 2018

Study information

• Verified date: August 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 30, 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Behavioral:
• Brain Training (Active)
Online computer games targeting attention, EF, and problem-solving
• Brain Training (Passive)
Online computer games targeting attention, EF, and problem solving
• Brain Training (Active or Passive)
Online computer games targeting attention, EF, and problem solving

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change fro baseline on Executive Function Composite Measure at 2 months	EF composite measured post "Brain Training"	2 months
Secondary	Change from baseline on Executive Function Composite measure at 5 months	EF composite measured 3-months post "Brain Training" and 5 months from baseline	5 months
Secondary	Change from baseline on Executive Function Composite measure at 8 months	EF composite measured 6-months post "Brain Training" and 8 months from baseline	8 months

External Links

•   Webpage with contact information for the Brain Training study