NCT02428205

Combined Effects of Early Behavioral Intervention and Propranolol on ASD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Propranolol	Participant will receive Propranolol prior to each EIBI session
DRUG	Placebo	Participant will receive placebo prior to each EIBI session

Timeline

• Start date: 2015-04-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2015-04-28
• Last updated: 2024-03-04
• Results posted: 2024-03-04

Locations

1 site across 1 country: United States