Autism Spectrum DisorderNCT04066673
Intelligence Quotient Assessment in Children With Autistic Spectrum Disorders.
An observational study of Autism Spectrum Disorder, run by Assiut University.
Trial summary
The aim of this study is to assess the cognitive strengths and weaknesses of children with autism and the possible effect of age and IQ on Stanford-Binet Intelligence Scale, 5th Edition. Such analysis will help us for prompt and early intervention. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Stanford-Binet Intelligence Scale, 5th Edition
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Oct 2020
- Phase
- Observational
- 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 3 to 18 years
- All sexes
- Child, Adult
Study population: Forty children will participate in the study, clinically diagnosed by CARS Scoring IQ will be assessed by Stanford-Binet Intelligence Scales, 5th Edition have autism .They will be recruited from children attending Assiut University Hospital.
Who may be able to join
- Age: from3 to18 years
- Gender: both sexes will be included in the study
- Clinical ASD diagnosis.
- Full Scale test results available for SB5.
Who cannot join
- 1- Age below 3years or above 18 years. 2- Mental Retardation due to other causes than autism. 3- Presence of other chronic illnesses affecting their quality of lives.
Trial locations and contacts
No sites are listed yet.
Prof. Mohamed Mahrous EL-Tellawy, Professor of pediatric contact
About this study
The aim of this study is to assess the cognitive strengths and weaknesses of children with autism and the possible effect of age and IQ on Stanford-Binet Intelligence Scale, 5th Edition. Such analysis will help us for prompt and early intervention.
Read the detailed description
Autism Spectrum Disorders (ASDs) are characterized by deficits in both social interaction and communication, as well as by restricted and repetitive patterns of behavior, and are a type of Pervasive Developmental Disorder (PDD). Intellectual disability (ID) is characterized by deficits in adaptive functioning, an intelligence quotient (IQ) that falls at least two standard deviations below average (i.e., below 70), and onset prior to adulthood (American Psychiatric Association, 2000).
Although ID is not a core symptom of ASD, there is an established relationship between the two constructs. Seventy percent of children with AD have a co-morbid diagnosis of ID (Bolte \& Poustka, 2002; Fombonne, 2005). It has been suggested that many children who would have been diagnosed with ID in the past would today receive an ASD diagnosis, even with identical symptomatology (Lecavalier et al., in press).
The SB5 is a descendent of the very first intelligence measure ever created. It tests general intellectual ability, and the Fifth Edition affords the ability to report Full Scale, Abbreviated, Nonverbal, and Verbal IQ scores(Roid, 2003).. One of the updated features of the SB5 is the nonverbal component, in that close to half of the responses no longer require verbal answers (Coolican, Bryson \& Zwaigenbaum, 2008).The Full Scale IQ is derived from the verbal and nonverbal scales, each with five subtests bearing the same names: Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual Spatial Processing, and Working Memory.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Stanford-Binet Intelligence Scale, 5th Edition
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanford-Binet Intelligence Scale, 5th EditionDiagnostic test
The SB5 is a descendent of the very first intelligence measure ever created. It tests general intellectual ability, and the Fifth Edition affords the ability to report Full Scale, Abbreviated, Nonverbal, and Verbal IQ scores
What is being measured
The primary outcome is the main question the study is designed to answer.
Intelligence Quotient assessment in autistic children by the Stanford-Binet Intelligence Scales, 5th Edition
assess the cognitive strengths and weaknesses of children with autism and the possible effect of age and IQ on Stanford-Binet Intelligence Scale, 5th Edition.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohammed Mohammed Tawfeek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066673
- Sponsor's protocol ID
- IQ in Autism
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bolte S, Poustka F. The relation between general cognitive level and adaptive behavior domains in individuals with autism with and without co-morbid mental retardation. Child Psychiatry Hum Dev. 2002 Winter;33(2):165-72. doi: 10.1023/a:1020734325815.
PubMed 12462353Coolican J, Bryson SE, Zwaigenbaum L. Brief report: data on the Stanford-Binet Intelligence Scales (5th ed.) in children with autism spectrum disorder. J Autism Dev Disord. 2008 Jan;38(1):190-7. doi: 10.1007/s10803-007-0368-2. Epub 2007 Apr 5.
PubMed 17410416
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligence Quotient Assessment in Children With Autistic Spectrum Disorders.
- ClinicalTrials.gov ID
- NCT04066673
- Acronym / sponsor ID
- IQ in Autism
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 26 Aug 2019 (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 aim of this study is to assess the cognitive strengths and weaknesses of children with autism and the possible effect of age and IQ on Stanford-Binet Intelligence Scale, 5th Edition. Such analysis will help us for prompt and early intervention.
Detailed description
Autism Spectrum Disorders (ASDs) are characterized by deficits in both social interaction and communication, as well as by restricted and repetitive patterns of behavior, and are a type of Pervasive Developmental Disorder (PDD). Intellectual disability (ID) is characterized by deficits in adaptive functioning, an intelligence quotient (IQ) that falls at least two standard deviations below average (i.e., below 70), and onset prior to adulthood (American Psychiatric Association, 2000).
Although ID is not a core symptom of ASD, there is an established relationship between the two constructs. Seventy percent of children with AD have a co-morbid diagnosis of ID (Bolte \& Poustka, 2002; Fombonne, 2005). It has been suggested that many children who would have been diagnosed with ID in the past would today receive an ASD diagnosis, even with identical symptomatology (Lecavalier et al., in press).
The SB5 is a descendent of the very first intelligence measure ever created. It tests general intellectual ability, and the Fifth Edition affords the ability to report Full Scale, Abbreviated, Nonverbal, and Verbal IQ scores(Roid, 2003).. One of the updated features of the SB5 is the nonverbal component, in that close to half of the responses no longer require verbal answers (Coolican, Bryson \& Zwaigenbaum, 2008).The Full Scale IQ is derived from the verbal and nonverbal scales, each with five subtests bearing the same names: Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual Spatial Processing, and Working Memory.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Forty children will participate in the study, clinically diagnosed by CARS Scoring IQ will be assessed by Stanford-Binet Intelligence Scales, 5th Edition have autism .They will be recruited from children attending Assiut University Hospital.
Key inclusion criteria (4 listed)
- Age: from3 to18 years
- Gender: both sexes will be included in the study
- Clinical ASD diagnosis.
- Full Scale test results available for SB5.
Key exclusion criteria (1 listed)
- 1- Age below 3years or above 18 years. 2- Mental Retardation due to other causes than autism. 3- Presence of other chronic illnesses affecting their quality of lives.
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 |
|---|---|---|
| Stanford-Binet Intelligence Scale, 5th EditionThe SB5 is a descendent of the very first intelligence measure ever created. It tests general intellectual ability, and the Fifth Edition affords the ability to report Full Scale, Abbreviated, Nonverbal, and Verbal IQ scores | Diagnostic test | – |
Primary outcome
Intelligence Quotient assessment in autistic children by the Stanford-Binet Intelligence Scales, 5th Edition
Time frame: Baseline
assess the cognitive strengths and weaknesses of children with autism and the possible effect of age and IQ on Stanford-Binet Intelligence Scale, 5th Edition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 12462353Bolte S, Poustka F. The relation between general cognitive level and adaptive behavior domains in individuals with autism with and without co-morbid mental retardation. Child Psychiatry Hum Dev. 2002 Winter;33(2):165-72. doi: 10.1023/a:1020734325815.
- Background: PubMed 17410416Coolican J, Bryson SE, Zwaigenbaum L. Brief report: data on the Stanford-Binet Intelligence Scales (5th ed.) in children with autism spectrum disorder. J Autism Dev Disord. 2008 Jan;38(1):190-7. doi: 10.1007/s10803-007-0368-2. Epub 2007 Apr 5.
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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.
Prof. Mohamed Mahrous EL-Tellawy, Professor of pediatric contact
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Assiut University.
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 4 inclusion and 1 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Asmaa Mohammed Mohammed, Resident (01155096915, Asmaa_tawfeek@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intelligence Quotient assessment in autistic children by the Stanford-Binet Intelligence Scales, 5th Edition (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04066673, which also lists 2 linked publications.
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 28 Aug 2019.