Autism Spectrum Disorder Clinical Trial
— BrainREADOfficial title:
The Efficacy of a Visualizing Reading Intervention on Improving the Brain's Reading Network in Children With Autism
The overarching goal of this proposal is to test the impact of a comprehensive reading intervention program (Visualizing and Verbalizing) on changing the neurobiological mechanisms underlying reading comprehension deficits in children with autism spectrum disorders (ASD). To this end, the investigators will test a group of children with ASD and NT control participants who share common characteristic of average level decoding along with below average reading comprehension. Inclusion of an additional NT group that does not have any reading comprehension deficit will provide another control for additional comparisons.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 13 Years |
Eligibility | Inclusion Criteria: 1. Full Scale and Verbal IQs > 70 2. be 7-13 years of age; 3. no antipsychotics for at least one month 4. no anti-epileptics/convulsants for at least one week 5. no stimulants for 24 hours prior to testing; and 6. subjects with ASD meet DSM-V criteria (American Psychiatric Association, 2013) 7. Neurotypical participants will be medically healthy (below ASD symptom cutoff score on the SCQ (Rutter, Bailey, & Lord, 2003); without a self-reported and parent- reported history of neurologic or psychiatric disorders; and without a family history of ASD) 8. The NT-EXP participants need to have similar profile of reading comprehension difficulties as the ASD participants with average decoding accompanied by below average reading comprehension. Exclusion Criteria: 1. contraindication for MRI (cardiac pacemaker, aneurysm clip, cochlear implants, Intra Uterine Device, shrapnel, neurostimulators, defibrillator, artificial heart valve, or history of metal fragments in eyes, pregnancy, a body weight of more than 250 lbs. and claustrophobia) 2. seizure disorder or history of head injury |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama | Tuscaloosa | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama, Tuscaloosa | University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional and anatomical changes in the brain | changes in the brain, measured by Magnetic Resonance Imaging, as a result of reading intervention | 10-12 weeks | |
Primary | Change in reading comprehension | improvement in reading comprehension, measured by the Grey Oral Reading Test, as a result of reading intervention | 10-12 weeks | |
Secondary | Relationship between neurobiological and behavioral changes | changes in reading comprehension, measured by GORT, will be related to the changes in brain organization (measured by MRI) | 10-12 weeks |
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