Impact of Combined Medication and Behavioral Treatment for ASD & ADHD

Exclusion Criteria

• •1. Recent use of prohibited psychoactive medication in close proximity of baseline assessments. See MOP for specific medications that are prohibited and washout procedures. Use of a monoamine oxidase inhibitor is prohibited within 14 days of baseline.
• •2. Known allergic reactions to amphetamines or components of Adzenys-XR-ODT.
• •3. Known history of sudden non-ischemic cardiac death in a first or second degree family member (sibling, parent, aunt, uncle, cousin or grandparent).
• •4. Personal history of significant cardiac abnormalities or disease, particularly rhythm abnormalities.
• •5. Significant visual, auditory or motor impairments that would preclude participation in ESDM-informed parent coaching or completion of key assessments.
• •6. Inability of the caregiver participating in P-ESDM and responding to questionnaires to fluently speak English.
• •7. Parent's participation in another parent coaching intervention on more than a monthly basis that may affect study provided therapy as determined by the PI or clinician.
• •8. Presence of any psychiatric conditions or psychiatric symptoms in addition to ASD and ADHD that would confound assessments and/or affect participation in the study as deemed by the PI or clinician.
• •9. Known genetic (e.g. Fragile X) or neurological syndrome or condition with established link to autism, but not events in which the link to ASD is less well known/established (e.g., 16p11.2 CNVs, CHD8 mutations, Trisomy 21, 22q deletion syndrome)
• •10. History of epilepsy or seizure disorder (except for history of simple febrile seizures or if the child is seizure free (regardless of seizure type) for the past year).
• •11. History of neonatal brain damage. (eg., with diagnoses hypoxic or ischemic event)
• •12. Any known environmental circumstances that is likely to account for the picture of autism in the proband (severe nutritional or psychological deprivation etc.)
• •13. Study clinician judgment that it is not in the best interests of the participant and/or the study for the child to participate.