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Reading Intervention for Autism (BrainREAD Trial)

Phase < 1
Recruiting
Research Sponsored by University of Alabama, Tuscaloosa
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 10-12 weeks
Awards & highlights

BrainREAD Trial Summary

This trial will test the impact of a reading intervention program on children with ASD to see if it changes the neurobiological mechanisms underlying reading comprehension deficits.

Who is the study for?
This trial is for children aged 7-13 with Autism Spectrum Disorder (ASD) who have average decoding skills but below-average reading comprehension. They must not be on certain medications like antipsychotics, anti-epileptics, or stimulants before testing and should have an IQ over 70. Neurotypical kids without ASD can join if they also struggle with reading comprehension.Check my eligibility
What is being tested?
The study tests a reading program called Visualizing and Verbalizing to see if it improves brain connectivity related to reading in kids with ASD. It compares the effects of this intervention between children with ASD and neurotypical children who both face similar challenges in understanding what they read.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention focused on education, there are no direct medical side effects expected from the Visualizing and Verbalizing program itself.

BrainREAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in reading comprehension
Brain
Secondary outcome measures
Behavior Therapy

BrainREAD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ASD-EXP and NT-EXPExperimental Treatment1 Intervention
Autistic children and Neurotypical children who receive intervention between pre and post testing
Group II: ASD-WLC and NTActive Control1 Intervention
Autistic children who receive intervention only after their pre and post testing and Neurotypical children who do not receive any intervention

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamOTHER
1,590 Previous Clinical Trials
2,281,154 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
827 Patients Enrolled for Autism Spectrum Disorder
University of Alabama, TuscaloosaLead Sponsor
44 Previous Clinical Trials
19,316 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
505 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this clinical trial allow those of advanced age to participate?

"Based on the parameters of this study, participants must fall between 7 and 13 years old."

Answered by AI

How many individuals have registered to partake in this experiment?

"Affirmative. The clinical trial data found on clinicaltrials.gov shows that the research is actively seeking participants, with a starting date of January 10th 2019 and most recent update occurring on September 30th 2022. 200 people are required from 1 centre to complete the study."

Answered by AI

Are there still openings for participants in this experiment?

"According to the records on clinicaltrials.gov, this medical experiment is currently seeking patients and has been since January 10th 2019. The last update was made on September 30th 2022."

Answered by AI

What qualifications must an individual possess to be eligible for this investigation?

"This clinical study aims to recruit two hundred children, ranging from 7-13 years of age and diagnosed with autism spectrum disorder. Furthermore, participants must adhere to several criteria in order for eligibility: no stimulants within 24 hours prior, absence of antipsychotics treatment for one month minimum, lack of antiepileptics/convulsants use over the last week; meet American Psychiatric Association's DSM-V standards (2013); Full Scale IQs score higher than 70 and possess similar reading comprehension difficulties as ASD patients but featuring average decoding complemented by below standard reading understanding."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of Alabama
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

~12 spots leftby Aug 2024