Combined Effects of Early Behavioral Intervention and Propranolol on ASD

Last updated: February 28, 2024
Sponsor: University of Missouri-Columbia
Overall Status: Completed

Phase

N/A

Condition

Autism

Treatment

Propranolol

Placebo

Clinical Study ID

NCT02428205
2001935
  • Ages 3-10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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, reactiveairway/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 lessthan 75 at the outset of the study will be excluded.

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Propranolol
Phase:
Study Start date:
April 01, 2015
Estimated Completion Date:
November 01, 2022

Study 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.

Connect with a study center

  • Thompson Center for Autism & Neurodevelopmental Disorders

    Columbia, Missouri 65211
    United States

    Site Not Available

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