Attention Deficit Hyperactivity DisorderNCT02588365
Brain Training in Children With/At-risk for Attention-Deficit/Hyperactivity Disorder and Executive Function Impairment
A study testing Brain Training (Active), Brain Training (Passive) and Brain Training (Active or Passive) in people with Attention Deficit Hyperactivity Disorder, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Brain Training (Active), Brain Training (Passive) and Brain Training (Active or Passive)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Major neurosensory impairment (ie blind, deaf) that interferes with testing
- Genetic syndrome
- Inability to comprehend task instructions
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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."
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Brain Training (Active), Brain Training (Passive), Brain Training (Active or Passive)
- Keywords
- Attention Deficit Hyperactivity Disorder; executive function; preschool
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Training (Active)Behavioural
Online computer games targeting attention, EF, and problem-solving
Brain Training (Passive)Behavioural
Online computer games targeting attention, EF, and problem solving
Brain Training (Active or Passive)Behavioural
Online computer games targeting attention, EF, and problem solving
| Study group | Role | What they receive |
|---|---|---|
| Brain Training (Active) | Experimental | The children in this arm receive one type of "Brain Training" with online computer games that actively matches their skill level. Receives: Behavioral: Brain Training (Active) |
| Brain Training (Passive) | Experimental | The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent level. Receives: Behavioral: Brain Training (Passive) |
| Cross-over | Experimental | 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). Receives: Behavioral: Brain Training (Active or Passive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change fro baseline on Executive Function Composite Measure at 2 months
EF composite measured post "Brain Training"
Measured: 2 months
Secondary outcomes (2)
Change from baseline on Executive Function Composite measure at 5 months
EF composite measured 3-months post "Brain Training" and 5 months from baseline
Measured: 5 months
Change from baseline on Executive Function Composite measure at 8 months
EF composite measured 6-months post "Brain Training" and 8 months from baseline
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene M. Loe, MD, Stanford University
- Investigators
- Irene M Loe, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588365
- Sponsor's protocol ID
- 30874-2
- Status last verified
- Aug 2019
- First submitted
- 26 Oct 2015
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02588365
- Acronym / sponsor ID
- 30874-2
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder; executive function; preschool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain Training (Active) | Experimental | Behavioral: 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) | Experimental | Behavioral: 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 | Experimental | Behavioral: 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). |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Major neurosensory impairment (ie blind, deaf) that interferes with testing
- Genetic syndrome
- Inability to comprehend task instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Training (Active)Online computer games targeting attention, EF, and problem-solving | Behavioural | Brain Training (Active) |
| Brain Training (Passive)Online computer games targeting attention, EF, and problem solving | Behavioural | Brain Training (Passive) |
| Brain Training (Active or Passive)Online computer games targeting attention, EF, and problem solving | Behavioural | Cross-over |
Primary outcome
Change fro baseline on Executive Function Composite Measure at 2 months
Time frame: 2 months
EF composite measured post "Brain Training"
2 secondary outcomes
Change from baseline on Executive Function Composite measure at 5 months
Time frame: 5 months
Change from baseline on Executive Function Composite measure at 8 months
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene M Loe, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Training (Active), Brain Training (Passive) and Brain Training (Active or Passive) in people with Attention Deficit Hyperactivity Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change fro baseline on Executive Function Composite Measure at 2 months (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.