View Clinical Trial (Medical Research Study)
Development of a Multi-faceted Cognitive Training Program for Children With ADHD
| City: |
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Cincinnati |
| State: |
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Ohio |
| Zip Code: |
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45229 |
| Conditions: |
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Attention Deficit Hyperactivity Disorder |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Consent: The family must provide signature of informed consent by parents or legal
guardians.
- Age at time of Screening: 7 to 12 years of age, inclusive.
- Gender: includes male and female children.
- ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD-PIT or
ADHD-CT subtype. Section D.4 below describes in detail the diagnostic process for
arriving at diagnosis.
- Cognitive Functioning: IQ of greater than 80 as estimated by the Wechsler
Intelligence Scale for Children Fourth Edition.
- Learning Disability: Children must score 75 or above on two of the Wechsler
Individual Achievement Test (WIAT) subtests (Reading & Numerical Operations).
- School: Children must be enrolled in a school setting from which teacher ratings can
be obtained.
- History of Psychiatric Medications: Children may be taking psychiatric medications.
However, they must present with significant ADHD inattention symptoms while on
medication in order to be included in the study. We will ask that children on ADHD
medications to refrain from altering the dosage for 10 weeks from study enrollment to
after the immediate post-intervention follow-up. In order to screen for possible
medication adjustments, all parents will be asked during the initial phone screen if
their child is on an ADHD medication and if they anticipate a change in that
medication dosage. If they answer that they anticipate a dosage change, they will be
excluded from the study.
Exclusion Criteria:
- Understanding Level. The patient and parent cannot understand or follow instructions
given in the study.
- Exclusionary Psychiatric Conditions: Children who meet diagnostic criteria on the
K-SADS for OCD, any psychotic disorder, major depressive disorder or bipolar disorder
will be excluded from participation.
- Developmental Disabilities. Patients will be excluded if they are deemed to be
significantly developmentally delayed or have a pervasive developmental disorder.
Developmental delay will be operationally defined as an IQ score below 80. Children
scoring 80 or above will be included. A semi-structured interview, the CAARTE, will
be used to screen for autism.
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| NCT ID: |
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NCT01352468 |
| Primary Contact: |
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Principal Investigator
Jeffery N Epstein, Ph.D.
Cincinnati Childrens Hospital Medical Center
Anne Bush, B.A.
Phone: 513-636-1506
Email: anne.bush@cchmc.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cincinnati, Ohio 45229
United States
Anne Bush, B.A.
Phone: 513-636-1506
Email: anne.bush@cchmc.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
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