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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT04240756
Eligibility Criteria:
Child Inclusion Criteria:
* Be at least 3 years old and no more than 8 years old
* ADHD medication naive or have not had an adequate trial of stimulant medications
* Have ≥5 inactivity or ≥5 hyperactivity symptoms rated as 1 or 2 on the Vanderbilt
* Have a CGI-S-ADHD rating ≥4 and \<7
Child Exclusion Criteria:
* Severe ADHD (CGI-S-ADHD score of greater than 6)
Parent Inclusion Criteria:
* Be at least 21 years old and English-speaking
* Meet full DSM-5 criteria for ADHD (any subtype)
* Have findings on physical examination, laboratory studies, vital signs, and electrocardiogram judged to be normal for age with no contraindications for stimulant medication
* Have pulse and blood pressure (BP) within 95% of age and gender mean
* Women of childbearing potential agree to use a medically accepted contraception method consistently
* Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent (i.e. Beck Depression Inventory (BDI)-II score of 2 or 3 to Q9 which assesses suicidal thoughts); and (b) if receiving an antidepressant medication, their medication is well-tolerated, has not changed within 30 days, and the prescribing physician approves of their participation in the study
* Must have regular access to a computer or phone that can be used to deliver the behavioral parent training
Parent Exclusion Criteria:
* History of allergic or other severe negative reactions to study medications
* Substance abuse in the past 3 months, or a positive baseline urinary toxic screen that is not explained by a time-limited medical circumstance
* Current bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring other immediate treatment
* History of chronic/acute medical disorder for which stimulant therapy would be contraindicated (e.g., glaucoma, hypertension)
* Stimulant medication for ADHD in the past 30 days
* Is pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
65 Years
Study:
NCT04240756
Study Brief:
Protocol Section:
NCT04240756