Impact of a reading intervention on brain connectivity in children with autism

The Efficacy of a Visualizing Reading Intervention on Improving the Brain's Reading Network in Children With Autism

This study is testing a new reading program to see if it can help children with autism improve their reading skills and how their brains work while reading.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 7 Years to 13 Years
• Sex: All
• Sponsor: University of Alabama, Tuscaloosa (Academic / other)
• Locations: 1 site (Tuscaloosa, Alabama)
• Trial ID: NCT05568056 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of a comprehensive reading intervention program called Visualizing and Verbalizing on the neurobiological mechanisms related to reading comprehension deficits in children with autism spectrum disorders (ASD). The research will involve children with ASD and neurotypical (NT) control participants who have average decoding skills but below-average reading comprehension. The study will utilize multimodal neuroimaging techniques, including task-based and resting state functional MRI, to assess changes in brain circuitry associated with reading comprehension. By comparing the outcomes of the ASD group with those of NT participants, the study seeks to provide insights into effective interventions for improving reading comprehension in children with ASD.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 7-13 with autism spectrum disorder who have average decoding abilities but struggle with reading comprehension.

Not a fit: Patients who do not meet the inclusion criteria, such as those with significant neurological or psychiatric disorders or those not meeting the DSM-V criteria for ASD, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance reading comprehension skills in children with autism, leading to improved academic performance and overall quality of life.

How similar studies have performed: While there is evidence supporting the need for effective reading interventions in children with ASD, this specific approach using multimodal neuroimaging is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Tuscaloosa, Alabama

• University of Alabama — Tuscaloosa, Alabama, United States (Recruiting)

Study contacts

• Study coordinator: Rajesh Kana, PhD

Conditions Autism Spectrum Disorder; Autism; Reading Problem