Clinical trial NCT01133418: Cognitive Training Trial
Official title: Efficacy of a Cognitive Training Intervention for Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-05-28
Enrollment: 72
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
timeFrame: 2 months
measure: Clinical Global Impression - Improvement
timeFrame: 2 months
Secondary outcomes:
measure: Intra-individual Variability on Go/No-Go Task
timeFrame: 2 months
measure: Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate)
timeFrame: 2 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Center for ADHD, Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
References: