Combined Effects of Early Behavioral Intervention and Propranolol on ASD

NCT ID: NCT02428205

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2022-11-01

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.

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Propranolol arm

Propranolol will be administered in the form of a liquid dose via oral syringe by the participants' parent/caregiver an hour before each EIBI session. To minimize risk, the bodyweight adjusted minimum dose of propranolol used safely for test anxiety in healthy adults (10mg) will be used: participants weighing \> 30 kg will be given 4 mg, participants weighing 22.5 - 30 kg will be given 3 mg, participants weighing 15 - 22.5 kg will be given 2 mg. Participants weighing \< 15 kg will be excluded for safety reasons.

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Participant will receive Propranolol prior to each EIBI session

Placebo arm

Placebo will be administered in the form of a liquid dose via oral syringe by the participants' parent/caregiver an hour before each EIBI session.The same bodyweight adjusted doses specified in the propranolol arm will be used for this arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participant will receive placebo prior to each EIBI session

Interventions

Propranolol

Participant will receive Propranolol prior to each EIBI session

Intervention Type: DRUG

Placebo

Participant will receive placebo prior to each EIBI session

Intervention Type: DRUG

Other Intervention Names

Inderal

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Autism Science Foundation

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

David Beversdorf

Associate Professor, Radiology, Neurology, Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Q Beversdorf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

Thompson Center for Autism & Neurodevelopmental Disorders

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2001935

Identifier Type: -

Identifier Source: org_study_id