Autism Spectrum DisorderEarly Phase 1BrainREADNCT05568056
Efficacy of Reading Intervention on the Brain Connectivity in Autism
A Early Phase 1 study testing Visualizing and Verbalizing for Language comprehension and Thinking in people with Autism Spectrum Disorder and Autism, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Reading Problem
- What is being tested?
- Visualizing and Verbalizing for Language comprehension and Thinking
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2019to 31 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jennifer Camp contact
United States1 site, 1 recruiting
- Recruiting
University of Alabama
Tuscaloosa, Alabama, 35487
Rajesh Kana, 205-348-1391, rkkana@ua.edu
Skyler Hughes, smhughes4@ua.edu
About this study
Official 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.
Read the detailed description
The overarching goal of this proposal is to test the impact of a comprehensive reading intervention program on changing the neurobiological mechanisms underlying reading comprehension deficits in children with autism spectrum disorders (ASD). There is evidence that as many as 65% of children with ASD have a deficit in reading comprehension. This ultimately has profound impact on language, learning, and academic success (Nation, Clarke, Wright, \& Williams, 2006). Poor reading comprehension in children with autism is often masked by their relative strength in decoding. Moreover, reading comprehension in general is not well-understood, and as a result, current treatments are limited in its potential and in its effectiveness. In this project, 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. The investigators also have included an additional NT group without any reading comprehension deficits, and this group will serve as another control for additional comparisons. The investigators will test the efficacy of an intensive reading intervention training program, visualizing and verbalizing for language comprehension and thinking (V/V), and its effects on changing the brain circuitry underlying reading comprehension in children with ASD. The project will use multimodal neuroimaging with task-based functional MRI, resting state functional MRI, diffusion imaging, and neuropsychological testing. It should be noted that neuroimaging as well as behavioral studies of language in autism have largely ignored a subgroup of children with comprehension deficits. The proposed project addresses this critical gap by targeting brain plasticity in children with ASD (age: 7-13 years). Average decoding ability with below average comprehension of language in children is an important problem of academic and public health significance. The outcome of this study will throw more light on this important subgroup of children. In addition, it will test the efficacy of an intervention that can, in the long-run, help NT and children with reading problems to achieve academic success. Findings may provide important preliminary steps in using V/V intervention in schools.
This project will use multimodal neuroimaging [functional MRI, structural MRI, and diffusion weighted imaging (DWI)] to assess changes in brain function and white matter connectivity in autism. This will be accomplished using 4 groups of participants matched on age, gender and IQ: 1) children with ASD who will undergo the V/V intervention after their first MRI scan (ASD-EXP) (n=50); 2) children with ASD who will receive the intervention at the end of the trial (wait-list controls) (ASD-WLC) (n=50); 3) NT children with reading comprehension deficits who will receive intervention after their first MRI scan (NT-EXP) (n = 50); and 4) NT (n = 50) control participants (no reading comprehension deficits) who will be scanned twice but will not receive any intervention. A total of 200 participants (with 20 additional participants to account for attrition) will take part in this project. It should be noted that neuroimaging as well as behavioral studies of language in autism have largely ignored children with comprehension deficits. The proposed project addresses this critical gap by targeting brain plasticity in ASD and NT children (age: 7-13 years), with the following three independent, but inter-related specific aims.
AIM #1: Examine the differential impact of V/V intervention on the functional organization (activation and functional connectivity) of the brain's reading network (Koyama et al., 2011) in ASD and NT children who share reading comprehension deficits.
Hypothesis: Along with improvement in comprehension in both groups, the investigators predict that the connectivity between classic language areas and regions involved in visual/visuospatial processing will be stronger in ASD-EXP children compared to NT-EXP children after intervention.
AIM #2: Test the impact of V/V intervention on the microstructural connectivity of the white matter underlying reading network (primarily AF: the arcuate fasciculus and UF: the uncinate fasciculus) in ASD and NT children who share similar reading comprehension deficits.
Hypothesis: At post-scanning, white matter connectivity of the AF and UF (connecting frontal and temporal areas) will be increased in children who receive V/V intervention compared to themselves and to waitlist controls. It is expected that the extent of this change will differ between ASD-EXP and NT-EXP groups.
AIM #3: Establish brain-behavior relationship by testing how improvements in language skills (decoding, comprehension, fluency and other components) and autism symptoms predict post-intervention changes in neurobiological and behavioral profiles in ASD and NT children.
Hypotheses: 1) Improvement in comprehension (as measured by Gray Oral Reading Test) following V/V intervention will predict increased activation, functional connectivity, and white matter connectivity in the reading network in NT-EXP and ASD-EXP groups; 2) ASD symptom severity will negatively predict improvement in comprehension and in reading network response, and may help differentiate the nature of language deficits between ASD-EXP and NT-EXP groups.
The outcomes of this study will inform us about intervention-related changes in brain and behavior in ASD children with language deficits. This, in turn, may have translational significance in education. The inclusion of NT-EXP and NT control groups provide a unique opportunity to glean further into the nature of reading deficits in ASD and NT children and to the specificity of such deficits in ASD.
- Conditions
- Autism Spectrum Disorder, Autism, Reading Problem
- Being tested
- Visualizing and Verbalizing for Language comprehension and Thinking
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualizing and Verbalizing for Language comprehension and ThinkingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| ASD-EXP and NT-EXP | Experimental | Autistic children and Neurotypical children who receive intervention between pre and post testing Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and anatomical changes in the brain
changes in the brain, measured by Magnetic Resonance Imaging, as a result of reading intervention
Measured: 10-12 weeks
Change in reading comprehension
improvement in reading comprehension, measured by the Grey Oral Reading Test, as a result of reading intervention
Measured: 10-12 weeks
Secondary outcomes (1)
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)
Measured: 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start10 Jan 2019
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- ASD participants randomly assigned to Experimental or Waitlist control groups. NT-EXP participants assigned to experimental group NT participants assigned to waitlist control group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568056
- Sponsor's protocol ID
- 19-03-2120
- Acronym
- BrainREAD
- Status last verified
- Nov 2023
- First submitted
- 27 Sep 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through NIH Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Visualizing Reading Intervention on Improving the Brain's Reading Network in Children With Autism
- ClinicalTrials.gov ID
- NCT05568056
- Acronym / sponsor ID
- BrainREAD / 19-03-2120
- Conditions
- Autism Spectrum Disorder, Autism, Reading Problem
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching goal of this proposal is to test the impact of a comprehensive reading intervention program on changing the neurobiological mechanisms underlying reading comprehension deficits in children with autism spectrum disorders (ASD). There is evidence that as many as 65% of children with ASD have a deficit in reading comprehension. This ultimately has profound impact on language, learning, and academic success (Nation, Clarke, Wright, \& Williams, 2006). Poor reading comprehension in children with autism is often masked by their relative strength in decoding. Moreover, reading comprehension in general is not well-understood, and as a result, current treatments are limited in its potential and in its effectiveness. In this project, 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. The investigators also have included an additional NT group without any reading comprehension deficits, and this group will serve as another control for additional comparisons. The investigators will test the efficacy of an intensive reading intervention training program, visualizing and verbalizing for language comprehension and thinking (V/V), and its effects on changing the brain circuitry underlying reading comprehension in children with ASD. The project will use multimodal neuroimaging with task-based functional MRI, resting state functional MRI, diffusion imaging, and neuropsychological testing. It should be noted that neuroimaging as well as behavioral studies of language in autism have largely ignored a subgroup of children with comprehension deficits. The proposed project addresses this critical gap by targeting brain plasticity in children with ASD (age: 7-13 years). Average decoding ability with below average comprehension of language in children is an important problem of academic and public health significance. The outcome of this study will throw more light on this important subgroup of children. In addition, it will test the efficacy of an intervention that can, in the long-run, help NT and children with reading problems to achieve academic success. Findings may provide important preliminary steps in using V/V intervention in schools.
This project will use multimodal neuroimaging [functional MRI, structural MRI, and diffusion weighted imaging (DWI)] to assess changes in brain function and white matter connectivity in autism. This will be accomplished using 4 groups of participants matched on age, gender and IQ: 1) children with ASD who will undergo the V/V intervention after their first MRI scan (ASD-EXP) (n=50); 2) children with ASD who will receive the intervention at the end of the trial (wait-list controls) (ASD-WLC) (n=50); 3) NT children with reading comprehension deficits who will receive intervention after their first MRI scan (NT-EXP) (n = 50); and 4) NT (n = 50) control participants (no reading comprehension deficits) who will be scanned twice but will not receive any intervention. A total of 200 participants (with 20 additional participants to account for attrition) will take part in this project. It should be noted that neuroimaging as well as behavioral studies of language in autism have largely ignored children with comprehension deficits. The proposed project addresses this critical gap by targeting brain plasticity in ASD and NT children (age: 7-13 years), with the following three independent, but inter-related specific aims.
AIM #1: Examine the differential impact of V/V intervention on the functional organization (activation and functional connectivity) of the brain's reading network (Koyama et al., 2011) in ASD and NT children who share reading comprehension deficits.
Hypothesis: Along with improvement in comprehension in both groups, the investigators predict that the connectivity between classic language areas and regions involved in visual/visuospatial processing will be stronger in ASD-EXP children compared to NT-EXP children after intervention.
AIM #2: Test the impact of V/V intervention on the microstructural connectivity of the white matter underlying reading network (primarily AF: the arcuate fasciculus and UF: the uncinate fasciculus) in ASD and NT children who share similar reading comprehension deficits.
Hypothesis: At post-scanning, white matter connectivity of the AF and UF (connecting frontal and temporal areas) will be increased in children who receive V/V intervention compared to themselves and to waitlist controls. It is expected that the extent of this change will differ between ASD-EXP and NT-EXP groups.
AIM #3: Establish brain-behavior relationship by testing how improvements in language skills (decoding, comprehension, fluency and other components) and autism symptoms predict post-intervention changes in neurobiological and behavioral profiles in ASD and NT children.
Hypotheses: 1) Improvement in comprehension (as measured by Gray Oral Reading Test) following V/V intervention will predict increased activation, functional connectivity, and white matter connectivity in the reading network in NT-EXP and ASD-EXP groups; 2) ASD symptom severity will negatively predict improvement in comprehension and in reading network response, and may help differentiate the nature of language deficits between ASD-EXP and NT-EXP groups.
The outcomes of this study will inform us about intervention-related changes in brain and behavior in ASD children with language deficits. This, in turn, may have translational significance in education. The inclusion of NT-EXP and NT control groups provide a unique opportunity to glean further into the nature of reading deficits in ASD and NT children and to the specificity of such deficits in ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ASD participants randomly assigned to Experimental or Waitlist control groups. NT-EXP participants assigned to experimental group NT participants assigned to waitlist control group
| Arm | Type | Receives |
|---|---|---|
| ASD-EXP and NT-EXP | Experimental | Behavioral: Visualizing and Verbalizing for Language comprehension and ThinkingAutistic children and Neurotypical children who receive intervention between pre and post testing |
| 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 |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visualizing and Verbalizing for Language comprehension and ThinkingThe 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). | Behavioural | ASD-EXP and NT-EXP |
Primary outcome
Functional and anatomical changes in the brain
Time frame: 10-12 weeks
changes in the brain, measured by Magnetic Resonance Imaging, as a result of reading intervention
Change in reading comprehension
Time frame: 10-12 weeks
improvement in reading comprehension, measured by the Grey Oral Reading Test, as a result of reading intervention
1 secondary outcome
Relationship between neurobiological and behavioral changes
Time frame: 10-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Yes. Data will be shared through NIH Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Camp contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Visualizing and Verbalizing for Language comprehension and Thinking in people with Autism Spectrum Disorder and Autism, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Kana, PhD (2053481391, rkkana@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and anatomical changes in the brain (time frame: 10-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.