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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02588365
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 3
• Duration (Months): 39
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Behavioral: Brain Training (Active); Behavioral: Brain Training (Passive); Behavioral: Brain Training (Active or Passive)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2015
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brain Training (Active) The children in this arm receive one type of "Brain Training" with online computer games that actively matches their skill level.	Behavioral: Brain Training (Active); Online computer games targeting attention, EF, and problem-solving
Experimental: Brain Training (Passive) The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent level.	Behavioral: Brain Training (Passive); Online computer games targeting attention, EF, and problem solving
Experimental: Cross-over 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).	Behavioral: Brain Training (Active or Passive); Online computer games targeting attention, EF, and problem solving

Outcome Measures

Primary Outcome Measures

1. Change fro baseline on Executive Function Composite Measure at 2 months [2 months]

   EF composite measured post "Brain Training"

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Irene M Loe, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Irene M. Loe, MD, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02588365
• Other Study ID Numbers: 30874-2
• First Posted: Oct 27, 2015
• Last Update Posted: Aug 6, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Irene M. Loe, MD, Principal Investigator, Stanford University: Attention Deficit Hyperactivity Disorder; executive function; preschool
• Additional relevant MeSH terms: Hyperkinesis; Disease; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Aug 6, 2019