Cognitive Training Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 7 - 12 |
| Updated: | 4/21/2016 |
| Start Date: | September 2010 |
| End Date: | June 2016 |
Efficacy of a Cognitive Training Intervention for Children With ADHD
Currently, only two treatment modalities for pediatric attention deficit hyperactivity
disorder (ADHD) are considered evidence-based: (1) pharmacological and (2) behavioral
treatment. Recently, several studies have shown promising results suggesting efficacy for
cognitive training interventions for children with ADHD. These interventions directly train
cognitive function (i.e., attention, working memory) by having children practice cognitive
skills using computerized tasks. In these studies, improvements related to the cognitive
training intervention have been documented on neuropsychological tests, academic tasks, and
parent ratings of children's ADHD behavior. Given the ubiquitous finding of increased
reaction time (RT) variability among children with ADHD, the candidate worked with a group
of developers to modify a cognitive training intervention to target RT variability. That is,
train the children to be less variable in their responding. Initial clinical data from this
intervention suggest that intervention exposure improves behavioral outcomes. However, an
appropriate powered randomized clinical trial is necessary to experimentally demonstrate
intervention efficacy.Sixty-four (64) children diagnosed with ADHD (either Predominantly
Inattentive Type or Combined Type) will be randomly assigned to intervention or control
conditions. Children in the intervention group will receive 8 weeks of the Computerized
Progressive Attention Training (CPAT) intervention. Children in the control group will
receive the CPAT intervention but there will be no progression in difficulty based on
performance as in the intervention group. Children in both groups will be assessed
pre-intervention and immediately after the 8-week training on neuropsychological,
behavioral, and academic outcome measures. Hypothesis-driven data analyses will assess
intervention efficacy.
Hypothesis #1: Children in the experimental group exposed to the CPAT intervention will show
greater improvement from pre- to post-intervention on neuropsychological tests compared to
children in the control group.
Hypothesis #2: Children in the experimental group exposed to the CPAT intervention will show
greater improvement from pre- to post-intervention on parent and teacher behavioral ratings
of ADHD behavior compared to children in the control group.
Hypothesis #3: Children in the experimental group exposed to the CPAT intervention will show
greater improvement from pre- to post-intervention on academic outcomes compared to children
in the control group.
disorder (ADHD) are considered evidence-based: (1) pharmacological and (2) behavioral
treatment. Recently, several studies have shown promising results suggesting efficacy for
cognitive training interventions for children with ADHD. These interventions directly train
cognitive function (i.e., attention, working memory) by having children practice cognitive
skills using computerized tasks. In these studies, improvements related to the cognitive
training intervention have been documented on neuropsychological tests, academic tasks, and
parent ratings of children's ADHD behavior. Given the ubiquitous finding of increased
reaction time (RT) variability among children with ADHD, the candidate worked with a group
of developers to modify a cognitive training intervention to target RT variability. That is,
train the children to be less variable in their responding. Initial clinical data from this
intervention suggest that intervention exposure improves behavioral outcomes. However, an
appropriate powered randomized clinical trial is necessary to experimentally demonstrate
intervention efficacy.Sixty-four (64) children diagnosed with ADHD (either Predominantly
Inattentive Type or Combined Type) will be randomly assigned to intervention or control
conditions. Children in the intervention group will receive 8 weeks of the Computerized
Progressive Attention Training (CPAT) intervention. Children in the control group will
receive the CPAT intervention but there will be no progression in difficulty based on
performance as in the intervention group. Children in both groups will be assessed
pre-intervention and immediately after the 8-week training on neuropsychological,
behavioral, and academic outcome measures. Hypothesis-driven data analyses will assess
intervention efficacy.
Hypothesis #1: Children in the experimental group exposed to the CPAT intervention will show
greater improvement from pre- to post-intervention on neuropsychological tests compared to
children in the control group.
Hypothesis #2: Children in the experimental group exposed to the CPAT intervention will show
greater improvement from pre- to post-intervention on parent and teacher behavioral ratings
of ADHD behavior compared to children in the control group.
Hypothesis #3: Children in the experimental group exposed to the CPAT intervention will show
greater improvement from pre- to post-intervention on academic outcomes compared to children
in the control group.
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 Abbreviated
Scale of Intelligence.
- Learning Disability: Children must score above 75 on all three of the Wechsler
Individual Achievement Test (WIAT) subtests (Reading, Spelling, Numerical
Operations).
- School: Children must be enrolled in a school setting from which teacher ratings can
be obtained.
Exclusion Criteria:
- Understanding Level. The patient and parent cannot understand or follow instructions
given in the study.
- History of Psychiatric Medications: Children must not have taken psychiatric
medications within the past month. In addition, the family must indicate that they do
not plan on placing their child on medication for any psychiatric condition during
the course of 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. A
pervasive developmental delay will be defined as a T score above 65 on the Autism
Composite Scale of the PDD Behavior Inventory.
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