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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD071971 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Training (Active) | Behavioral | Online computer games targeting attention, EF, and problem-solving match the child's skill level. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on Executive Function Composite Measure at 2 months | EF composite measured post "Brain Training." | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline on Executive Function Composite Measure at 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene M Loe, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Brain Training (Passive) | Behavioral | Online computer games targeting attention, EF, and problem solving are set to a consistent level. |
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| Brain Training (Active or Passive) | Behavioral | 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. |
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EF composite measured 6-months post "Brain Training" and 8 months from baseline
| 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 | 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" | 2 months |
| D000091642 | Urogenital Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |