Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Treatment enrollment rates |
Determine feasibility and acceptability of the CogMed training program by assessing treatment enrollment |
6 months |
|
Primary |
Attrition rates |
Determine feasibility and acceptability of the CogMed training program by assessing attrition rates. |
6 months |
|
Primary |
Change in scores on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) over time |
Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A). |
Baseline to 6 months |
|
Primary |
Change in scores on Conners' Continuous Performance Test - Third Edition (CPT-3) over time |
Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Conners' Continuous Performance Test - Third Edition (CPT-3). |
Baseline to 6 months |
|
Primary |
Change in scores on Delis-Kaplan Executive Function System (D-KEFS) over time |
Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Delis-Kaplan Executive Function System (D-KEFS). |
Baseline to 6 months |
|
Primary |
Change in scores on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-Update A, B, C, or D) over time |
Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-Update A, B, C, or D). |
Baseline to 6 months |
|
Primary |
Scores on Test of Premorbid Functioning (TOPF) at baseline |
Brief neuropsychological evaluations will be conducted at baseline before the participant is introduced to the CogMed® training program. During this time point, the scores are measured and compared on Test of Premorbid Functioning (TOPF) with other psychological measures. |
Baseline |
|
Primary |
Change in scores on Trial Making Test (TMT) over time |
Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Trial Making Test (TMT). |
Baseline to 6 months |
|
Primary |
Change in scores on Wechsler Memory Scale - Fourth Edition (WMS-IV) over time |
Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Wechsler Memory Scale - Fourth Edition (WMS-IV). |
Baseline to 6 months |
|
Secondary |
Change in scores on Beck Anxiety Inventory (BAI) over time |
Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Beck Anxiety Inventory (BAI). |
Baseline to 6 months |
|
Secondary |
Change in scores on Beck Depression Inventory-II (BDI-II) over time |
Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Beck Depression Inventory-II (BDI-II). |
Baseline to 6 months |
|