Status:
TERMINATED
Impact of Combined Medication and Behavioral Treatment for ASD & ADHD
Lead Sponsor:
Duke University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
36-131 years
Phase:
PHASE2
Brief Summary
Children with comorbid autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) have significantly worse outcomes than those with either ASD alone or ADHD alone. Effective ea...
Detailed Description
This randomized, placebo-controlled, Phase 2, single site, pilot study will evaluate the developmental impact of combined medication and behavioral treatment (COMB) versus placebo and behavioral treat...
Eligibility Criteria
Inclusion
- Provision of a parent signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged 36 months to less than 132 months.
- Diagnosed with both ASD and ADHD based consensus diagnosis informed by results of the Autism Diagnostic Observation Schedule 2nd edition (ADOS-2), Autism Diagnostic Interview - Revised (ADI-R), and a Standardized ADHD Diagnostic Interview and the MINI psychiatric diagnostic interview.
- In good general health as evidenced by medical history and physical exam and review of safety labs and electrocardiogram.
Exclusion
- 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.
- Known allergic reactions to amphetamines or components of Adzenys-XR-ODT.
- Known history of sudden non-ischemic cardiac death in a first or second degree family member (sibling, parent, aunt, uncle, cousin or grandparent).
- Personal history of significant cardiac abnormalities or disease, particularly rhythm abnormalities.
- Significant visual, auditory or motor impairments that would preclude participation in ESDM-informed parent coaching or completion of key assessments.
- Inability of the caregiver participating in P-ESDM and responding to questionnaires to fluently speak English.
- 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.
- 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.
- 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)
- 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).
- History of neonatal brain damage. (eg., with diagnoses hypoxic or ischemic event)
- Any known environmental circumstances that is likely to account for the picture of autism in the proband (severe nutritional or psychological deprivation etc.)
- Study clinician judgment that it is not in the best interests of the participant and/or the study for the child to participate.
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03242772
Start Date
December 14 2018
End Date
April 19 2021
Last Update
March 22 2022
Active Locations (1)
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1
Duke Center for Autism and Brain Development
Durham, North Carolina, United States, 27705