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Combined Effects of Early Behavioral Intervention and Propranolol on ASD

N/A

Waitlist Available

Led By David Q Beversdorf, MD

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Summary

This trial tests whether propranolol, a calming medication, combined with intensive therapy can improve social skills, language, and reduce anxiety in children with autism. Propranolol has been shown to improve cognitive performance, social skills, and conversation reciprocity in children with autism spectrum disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in General Social Outcome Measure (GSOM)

Change in Social Responsiveness Scale (SRS)

Secondary study objectives

Change in Aberrant Behavior Checklist (ABC)

Change in Autism Impact Measure (AIM)

Change in Preschool Anxiety Scale (PAS)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Propranolol armExperimental Treatment1 Intervention

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 II: Placebo armPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol

2010

Completed Phase 4

~1290

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