Clinical trial NCT02428205: Combined Effects of Early Behavioral Intervention and Propranolol on ASD
Official title: Combined Effects of Early Behavioral Intervention and Propranolol on ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Autism Science Foundation
First posted: 2015-04-28
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effects of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled pilot trial.

Detailed description: The investigators' specific aim is to examine the effects of serial doses of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled trial. The investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as pupillary light reflex and heart rate variability, and whether anxiety predicts treatment response. The investigators' hypothesis is that propranolol will augment the effects of behavioral therapy on social functioning and language abilities. The investigators have demonstrated benefits of propranolol on social functioning and language in previous single-dose studies in adults and adolescents with autism. The investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of autism spectrum disorder (ASD), defined in this study by the DSM-V criteria plus Autism Diagnostic Observation Schedule (ADOS) criteria for Autism.
* Aged 3-8
* Participants must also be enrolled in an early behavioral intervention program at the Thompson Center or another institution in Missouri for the duration of the study.

Exclusion Criteria:

* Non-autism learning disability (e.g. dyslexia)
* Major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder)
* Other neurological diagnosis
* Major head trauma
* Any of the following exclusionary criteria related to propranolol (diabetes, reactive airway/pulmonary disease, thyroid disease, bradyarrhythmias, unexplained syncope, narrow angle glaucoma, known hypersensitivity/adverse reaction to beta-blockers, potentially interacting drugs, underweight \< 15 kg)
* Any of the following exclusionary criteria related to the use of electrocardiogram (history of rash from adhesives)
* Any of the following exclusionary criteria related to the pupillary reflex measurement (uncorrectable visual acuity impairment).
* Participants with a heart rate of less than 60 or a systolic blood pressure of less than 75 at the outset of the study will be excluded.

Primary outcomes:
measure: Change in General Social Outcome Measure (GSOM)
timeFrame: Week 12
measure: Change in Social Responsiveness Scale (SRS)
timeFrame: Week 12
Secondary outcomes:
measure: Change in Preschool Anxiety Scale (PAS)
timeFrame: Week 12
measure: Change in Aberrant Behavior Checklist (ABC)
timeFrame: Week 12
measure: Change in Vineland Adaptive Behavior Scales-II (VABS)
timeFrame: Week 12
measure: Change in Autism Impact Measure (AIM)
timeFrame: Week 12
measure: Change in Preschool Language Scale (PLS):
timeFrame: Week 12
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Thompson Center for Autism & Neurodevelopmental Disorders
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: David Q Beversdorf, MD
role: PRINCIPAL_INVESTIGATOR
References: