Efficacy of Reading Intervention on the Brain Connectivity in Autism

NCT05568056 | Unknown Early Phase 1

• 1 other identifier: 19-03-2120
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Autism; Reading Problem

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Relationship between neurobiological and behavioral changes

  10-12 weeks

Study Arms (2)

ASD-EXP and NT-EXP

EXPERIMENTAL

Autistic children and Neurotypical children who receive intervention between pre and post testing

Behavioral: Visualizing and Verbalizing for Language comprehension and Thinking

ASD-WLC and NT

NO INTERVENTION

Autistic children who receive intervention only after their pre and post testing and Neurotypical children who do not receive any intervention

Interventions

Visualizing and Verbalizing for Language comprehension and Thinking BEHAVIORAL

The V/V intervention program is a language remediation program designed by Dr. Nanci Bell, and developed by the Lindamood-Bell Learning Processes (LBLP) (Bell, 1991b). It has been widely used among children with reading disorders, but not with children with ASD. This intervention is based on the use of nonverbal sensory input, in the form of imaged gestalts, in order to develop oral and written language comprehension, establish vocabulary, and develop higher order thinking skills (Bell, 1991a,b).

ASD-EXP and NT-EXP

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Full Scale and Verbal IQs \> 70
• be 7-13 years of age;
• no antipsychotics for at least one month
• no anti-epileptics/convulsants for at least one week
• no stimulants for 24 hours prior to testing; and
• subjects with ASD meet DSM-V criteria (American Psychiatric Association, 2013)
• 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)
• 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.

You may not qualify if:

• 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)
• seizure disorder or history of head injury

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Rajesh Kana, PhD

CONTACT

2053481391; rkkana@ua.edu

Jennifer Camp

CONTACT

jrcamp@ua.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ASD participants randomly assigned to Experimental or Waitlist control groups. NT-EXP participants assigned to experimental group NT participants assigned to waitlist control group

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 5, 2022
• Study Start: January 10, 2019
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data sharing through NDA has already been started; however, we have requested data to be made available to other researchers only after 2024.

Locations

US (1)