AutismNCT01505270
The Prevalence of Psychological and Medical Comorbidities Among Children Suffering From Autistic Spectrum Disorder and the Differences Between Ethnic Groups in Israel
An observational study of Autism, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
It is known that several psychological and medical comorbidities are frequently found among children suffering from autistic spectrum disorders. Our aim is to investigate which comorbidities are most common among those children and whether there are differences among the different ethnic groups found in Israel. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Autism
- What is being tested?
- Retrospective case study
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Mar 2013
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Community sample
Who may be able to join
- Diagnosed with autism
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Muhammad Mahajnah, MD, PhD
About this study
It is known that several psychological and medical comorbidities are frequently found among children suffering from autistic spectrum disorders. Our aim is to investigate which comorbidities are most common among those children and whether there are differences among the different ethnic groups found in Israel.
- Conditions
- Autism
- Being tested
- Retrospective case study
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective case studyOther
Retrospective case study
| Study group | Role | What they receive |
|---|---|---|
| Autistic Children | Not described Receives: Other: Retrospective case study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of autistic children with comorbidities
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505270
- Sponsor's protocol ID
- 0103-11-HYMC
- Status last verified
- Jan 2012
- First submitted
- 4 Jan 2012
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Psychological and Medical Comorbidities Among Children Suffering From Autistic Spectrum Disorder and the Differences Between Ethnic Groups in Israel
- ClinicalTrials.gov ID
- NCT01505270
- Acronym / sponsor ID
- 0103-11-HYMC
- Conditions
- Autism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 6 Jan 2012 (estimated)
- 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.
It is known that several psychological and medical comorbidities are frequently found among children suffering from autistic spectrum disorders. Our aim is to investigate which comorbidities are most common among those children and whether there are differences among the different ethnic groups found in Israel.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autistic Children | – | Other: Retrospective case study |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- Diagnosed with autism
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Retrospective case studyRetrospective case study | Other | Autistic Children |
Primary outcome
Percentage of autistic children with comorbidities
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 0 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 6 Jan 2012. 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 Israel. 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.
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 Muhammad Mahajnah, MD, PhD (972-4-6304463, mohamedm@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of autistic children with comorbidities (time frame: One year). 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 6 Jan 2012.