Combined Effects of Early Behavioral Intervention and Propranolol on ASD

NCT02428205 | Completed Results

• 1 other identifier: 2001935
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Outcome Measures

Primary Outcomes (2)

• Change in General Social Outcome Measure (GSOM)

  The GSOM is a brief evaluation tool that measures a participant's level of social functioning and how it changes with intervention. There GSOM includes 4 different tasks: conversational reciprocity, ability to recognize facial expressions, social problem solving, affect demonstration, and emotional perspective taking. The experimenter administers each component of the GSOM to the participant and then scores their responses according to a pre-determined scoring rubric. Each component is scored on a 1-5 or 0 - 2 scale, with higher total scores indicating better social functioning. A video camera will be used to record the participant's behavior during GSOM administration for the purposes of having two independent raters score the tasks after the study session is complete. A camera will also be used during the affect demonstration task of the GSOM. The overall score is used. The range is 6-132, with higher scores being better.

  Week 12

• Change in Social Responsiveness Scale (SRS)

  This 65-item, parent-report measure asks questions about a participants' social awareness, social information processing, capacity for reciprocal social responses, social anxiety or avoidance, and characteristic autistic preoccupations or traits. The total score is used with a range of 0-195, with lower scores being better.

  Week 12

Secondary Outcomes (5)

• Change in Preschool Anxiety Scale (PAS)

  Week 12

• Change in Aberrant Behavior Checklist (ABC)

  Week 12

• Change in Vineland Adaptive Behavior Scales-II (VABS)

  Week 12

• Change in Autism Impact Measure (AIM)

  Week 12

• Change in Preschool Language Scale (PLS):

  Week 12

Study Arms (2)

Propranolol arm

EXPERIMENTAL

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.

Drug: Propranolol

Placebo arm

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Propranolol DRUG

Participant will receive Propranolol prior to each EIBI session

Also known as: Inderal

Propranolol arm

Placebo DRUG

Participant will receive placebo prior to each EIBI session

Placebo arm

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Non-autism learning disability (e.g. dyslexia)
• Major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder)
• Other neurological diagnosis
• Major head trauma
• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Autism Science Foundation: collaborator

Study Sites (1)

Thompson Center for Autism & Neurodevelopmental Disorders

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

This was only a feasibility trial. We do not recommend emphasis be placed on the results due to the very small sample.

Results Point of Contact

• Title: Dr David Beversdorf
• Organization: University of Missouri

beversdorfd@health.missouri.edu

5738826081

Study Officials

• David Q Beversdorf, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Radiology, Neurology, Psychology

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 28, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-02

Locations

US (1)