An interventional study of Multifaceted cognitive training in Attention Deficit Hyperactivity Disorder, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a "well-established" evidence-base supporting their efficacy for children with ADHD. Both of these interventions have inherent limitations. Recently multiple studies have demonstrated that cognitive training may improve neuropsychological and behavioral functioning in children with ADHD. The magnitude of treatment effects for cognitive training has been comparable to treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes). A limitation of existing cognitive training programs that may limit their efficacy is that each has employed a unifaceted approach. Each intervention program has targeted a single cognitive domain (e.g., working memory). This is problematic since as a group, children with ADHD have multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition, delay aversion, intra-individual variability) and thus a unifaceted intervention does not address the multifaceted array of cognitive dysfunction in children with ADHD. Also, because individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive training approach may target areas which are non-deficient and miss areas of significant deficit in individual patients depending on their ideographic cognitive profile. The primary goal of the proposed research is to develop and test a multifaceted cognitive training intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby ensuring that children's unique areas of cognitive deficit are targeted. During Phase I (R21 grant), software and a manual will be developed consisting of four training tasks targeting response inhibition, verbal working memory, attention, and delay aversion. Each task will possess advancing levels of difficulty. On each task, children will receive feedback on performance accuracy as well as on intra-individual variability in reaction times. The software will be pilot tested in Phase I to determine performance thresholds and intervention duration. Also, focus groups will be conducted to obtain patient perceptions of each task's difficulty and interest level. In Phase II (R33 grant), a preliminary randomized clinical trial will be conducted in order to obtain initial estimates of treatment efficacy. Pre-, post-, and follow up outcomes will be collected on a wide range of neuropsychological, behavioral, and academic measures. Effect size estimates across outcomes will be used to guide sample size determinations for future clinical trials of multifaceted cognitive training.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 44 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
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Exclusion Criteria:
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Other: Multifaceted cognitive training
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Other: Multifaceted cognitive training
Four computerized training tasks
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms.
Time frame: 8 weeks
Reaction Time Variability on go/No-go Task
Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
Time frame: 8 weeks
Proportion of Words Read Accurately Using the AIMSWEB
Number of words read correctly divided by number of words read
Time frame: 8 weeks
| Milestone | Multifaceted Cognitive Training | Sham Cognitive Training |
|---|---|---|
| Started | 22 | 22 |
| Completed | 17 | 18 |
| Not completed | 5 | 4 |
Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms.
| units on a scale | Multifaceted Cognitive Training | Sham Cognitive Training |
|---|---|---|
| Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale | 25.94 ± 8.95 | 28.28 ± 8.21 |
Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
| milliseconds | Multifaceted Cognitive Training | Sham Cognitive Training |
|---|---|---|
| Reaction Time Variability on go/No-go Task | 182.51 ± 96.12 | 160.25 ± 95.82 |
Number of words read correctly divided by number of words read
| proportion of words read accurately | Multifaceted Cognitive Training | Sham Cognitive Training |
|---|---|---|
| Proportion of Words Read Accurately Using the AIMSWEB | .98 ± .01 | .98 ± .02 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multifaceted Cognitive Training | — | 0/22 (0%) | 0/22 (0%) |
| Sham Cognitive Training | — | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | Multifaceted Cognitive Training | Sham Cognitive Training | Total |
|---|---|---|---|
| <=18 years | 22 | 22 | 44 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Multifaceted Cognitive Training | Sham Cognitive Training | Total |
|---|---|---|---|
| Mean | 9.05 ± 1.73 | 9.22 ± 1.65 | 9.14 ± 1.68 |
| Sex: Female, Male(Participants) | Multifaceted Cognitive Training | Sham Cognitive Training | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 16 | 18 | 34 |
| Ethnicity (NIH/OMB)(Participants) | Multifaceted Cognitive Training | Sham Cognitive Training | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 22 | 21 | 43 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Multifaceted Cognitive Training | Sham Cognitive Training | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 1 | 4 | 5 |
| White | 20 | 18 | 38 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Multifaceted Cognitive Training | Sham Cognitive Training | Total |
|---|---|---|---|
| United States | 22 | 22 | 44 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati