N/A
Completed N=9
Combined Effects of Early Behavioral Intervention and Propranolol on ASD
Source: ClinicalTrials.gov NCT02428205 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Change in General Social Outcome Measure (GSOM) — 48.3; 20.0 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in General Social Outcome Measure (GSOM) |
48.3; 20.0 | — |
| PRIMARY Change in Social Responsiveness Scale (SRS) |
79.3; 72.0 | — |
| SECONDARY Change in Preschool Anxiety Scale (PAS) |
87.7; 71.5 | — |
| SECONDARY Change in Aberrant Behavior Checklist (ABC) |
72.7; 53.0 | — |
| SECONDARY Change in Vineland Adaptive Behavior Scales-II (VABS) |
70.7; 66.5 | — |
| SECONDARY Change in Autism Impact Measure (AIM) |
23.7; 24.5 | — |
| SECONDARY Change in Preschool Language Scale (PLS): |
87.7; 71.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02428205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.