Premature BirthNCT02588391
Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment
A study testing Brain Training (Active), Brain Training (Passive) and Brain Training (Active or Passive) in people with Premature Birth, 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 at risk for EF problems due to premature birth. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- 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
- 57 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 prematurely at <33 weeks gestation
- Able to comprehend task instructions
- EF impairment on standardized questionnaire (t-score of 60 or greater) or EF battery (lower quartile)
Who cannot join
- Major neurosensory impairment (i.e., blind, deaf) or technology dependence (i.e., ventilator dependent) that interferes with testing
- Genetic syndrome
- Inability to comprehend task instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Randomized Controlled Trial of Executive Function Training in Preterm Children at Risk for Inattention, Hyperactivity and Executive Function 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 at risk for EF problems due to premature birth. 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
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
- Premature Birth
- Being tested
- Brain Training (Active), Brain Training (Passive), Brain Training (Active or Passive)
- Keywords
- premature birth; executive function; preschool
- Medical subject headings
- Premature Birth
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 match the child's skill level.
Brain Training (Passive)Behavioural
Online computer games targeting attention, EF, and problem solving are set to a consistent level.
Brain Training (Active or Passive)Behavioural
Online computer games targeting attention, EF, and problem-solving either match the child's level or are set to a consistent level depending on which version the child has already completed.
| Study group | Role | What they receive |
|---|---|---|
| Active Brain Training | 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) |
| Passive Brain Training | Experimental | The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent skill level. Receives: Behavioral: Brain Training (Passive) |
| Cross-over | Other | 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 from baseline on Executive Function Composite Measure at 2 months
EF composite measured post "Brain Training."
Measured: 2 months
Secondary outcomes (4)
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
Change from baseline on Early Academic Skills Measures at 8 months
Composite scores from standardized measures of pre-academic skills and early literacy and numeracy measures at 6-months post "Brain Training" and 8 months from baseline
Measured: 8 months
Change from 8-month Executive Function Composite Measure at 10 months (cross over groups)
Children who cross-over to the other "Brain Training" intervention arm after the 8 month follow-up visit, will be re-assessed at the completion of the alternate version of "Brain Training"
Measured: 2 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 Premature BirthStudies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 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
- NCT02588391
- Sponsor's protocol ID
- 30874
- Other IDs
- K23HD071971
- 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 Preterm Children at Risk for Inattention, Hyperactivity and Executive Function Impairment
- ClinicalTrials.gov ID
- NCT02588391
- Acronym / sponsor ID
- 30874
- Conditions
- Premature Birth
- Keywords
- premature birth; executive function; preschool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 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 at risk for EF problems due to premature birth. 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
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 |
|---|---|---|
| Active Brain Training | 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. |
| Passive Brain Training | 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 skill level. |
| Cross-over | Other | 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 prematurely at <33 weeks gestation
- Able to comprehend task instructions
- EF impairment on standardized questionnaire (t-score of 60 or greater) or EF battery (lower quartile)
Key exclusion criteria (3 listed)
- Major neurosensory impairment (i.e., blind, deaf) or technology dependence (i.e., ventilator dependent) 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 match the child's skill level. | Behavioural | Active Brain Training |
| Brain Training (Passive)Online computer games targeting attention, EF, and problem solving are set to a consistent level. | Behavioural | Passive Brain Training |
| Brain Training (Active or Passive)Online computer games targeting attention, EF, and problem-solving either match the child's level or are set to a consistent level depending on which version the child has already completed. | Behavioural | Cross-over |
Primary outcome
Change from baseline on Executive Function Composite Measure at 2 months
Time frame: 2 months
EF composite measured post "Brain Training."
4 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
Change from baseline on Early Academic Skills Measures at 8 months
Time frame: 8 months
Change from 8-month Executive Function Composite Measure at 10 months (cross over groups)
Time frame: 2 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 Premature Birth, 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 from 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.