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This study is an investigation of the effect of a computer-based working memory training program on memory and language processing in at-risk children (e.g., those with working memory weaknesses) who have received cochlear implants.
The long-term goal of this research program is to improve speech-language outcomes in prelingually deaf children who receive CIs. The objective of this proposal is to investigate the short-term effects of a novel working memory training program on memory, learning, and speech-language outcomes in children with CIs. The specific hypothesis of this project is that completion of a behaviorally-based training program designed to increase working memory capacity will improve attention, working memory span, and working memory-related speech-language processing in a group of deaf children with CIs. This hypothesis is based on past research demonstrating the efficacy of working memory training programs in improving attention and working memory in children with attention deficits, as well as on past research showing an association between working memory and speech-language outcomes in children with CIs. Knowledge about the effects of working memory training on CI speech-language outcomes will provide a better understanding of the process by which children with CIs learn speech-language following implantation and may offer an entirely new avenue of intervention to improve speech-language outcomes, particularly in deaf children who show limited improvement following implantation.
The specific aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cogmed Working Memory Training | Experimental | Cogmed Working Memory Training Program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cogmed Working Memory Training Program | Behavioral | The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success. |
| Measure | Description | Time Frame |
|---|---|---|
| Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory) | This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory. | Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit) |
| Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory) | This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory. | Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit) |
| Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William G. Kronenberger, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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All eligible subjects were assigned to Cogmed working memory training.
Subjects were recruited over a 2 year period from a database of families whose children had received cochlear implants at a large university-based teaching hospital and who had consented to be contacted for participation in research studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cogmed Working Memory Training | Cogmed Working Memory Training Program Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Waiting Period |
| |||||||||||||
| Training Period |
| |||||||||||||
| 1-Month Follow-Up Period |
| |||||||||||||
| 6-Month Follow-Up Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cogmed Working Memory Training | Cogmed Working Memory Training Program Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory) | This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory. | Posted | Mean | Standard Deviation | Scores on a scale | Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening Visit | Screening Visit at Study Entry Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Kronenberger, Ph.D. | Indiana University School of Medicine | 317-944-8162 | wkronenb@iupui.edu |
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| ID | Term |
|---|---|
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
|
The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory. |
| Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Screening Visit |
Screening Visit at Study Entry Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success. |
| OG001 | Pretraining Visit | Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started |
| OG002 | Posttraining Visit | Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period) |
| OG003 | 1-Month Follow Up Visit | Visit 1 month after Cogmed working memory training was completed |
| OG004 | 6-Month Follow Up Visit | Visit 6 months after Cogmed working memory training completed |
|
|
|
| Primary | Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory) | This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory. | Posted | Mean | Standard Deviation | Scores on a scale | Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit) |
|
|
|
|
| Primary | Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory) | The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory. | Posted | Mean | Standard Deviation | Scores on a scale | Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit) |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Pretraining Visit | Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started | 0 | 9 | 0 | 9 |
| EG002 | Posttraining Visit | Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period) | 0 | 9 | 0 | 9 |
| EG003 | 1-Month Follow Up Visit | Visit 1 month after Cogmed working memory training was completed | 0 | 9 | 0 | 9 |
| EG004 | 6-Month Follow Up Visit | Visit 6 months after Cogmed working memory training completed | 0 | 9 | 0 | 9 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Change during training period
| t-test, 2 sided |
t(8)=4.05 |
| 0.004 |
| Mean Difference (Final Values) |
| 2.44 |
| Standard Deviation |
| 1.81 |
| 2-Sided |
| 95 |
| 1.05 |
| 3.84 |
| Superiority or Other |
| 1 Month Follow Up change from pre-training | t-test, 2 sided | t(8)=2.07 | 0.072 | Mean Difference (Final Values) | 2.11 | Standard Deviation | 3.06 | 2-Sided | 95 | -0.24 | 4.46 | Superiority or Other |
| 6 month follow up change from pre-training | t-test, 2 sided | t(8)=1.02 | 0.34 | Mean Difference (Final Values) | 0.78 | Standard Deviation | 2.28 | 2-Sided | 95 | -0.97 | 2.53 | Superiority or Other |
Training Period - Pretraining to Post-Training Visit
| t-test, 2 sided |
t(8)=2.46 |
| 0.039 |
| Mean Difference (Final Values) |
| -1.78 |
| Standard Deviation |
| 2.17 |
| 2-Sided |
| 95 |
| -3.44 |
| -0.11 |
| Superiority or Other |
| 1 Month Follow Up Period from Pretraining | t-test, 2 sided | t(8)=0.90 | 0.40 | Mean Difference (Final Values) | -0.89 | Standard Deviation | 2.98 | 2-Sided | 95 | -3.17 | 1.40 | Superiority or Other |
| 6 Month Follow Up period from pretraining | t-test, 2 sided | t(8)=0.89 | 0.40 | Mean Difference (Final Values) | -0.67 | Standard Deviation | 2.50 | 2-Sided | 95 | -2.59 | 1.26 | Superiority or Other |