Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT01352468
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT01352468
Study Brief:
Protocol Section:
NCT01352468