Combined Effects of Early Behavioral Intervention and Propranolol on ASD

  • STATUS
    Recruiting
  • End date
    Dec 26, 2024
  • participants needed
    30
  • sponsor
    University of Missouri-Columbia
Updated on 26 May 2022
pervasive developmental disorder
social interaction
behavior modification

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.

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.

Details
Condition Autism
Treatment Placebo, Propranolol
Clinical Study IdentifierNCT02428205
SponsorUniversity of Missouri-Columbia
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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