AutismNCT00367107
Autism in Adult Patients and the Effects on Caregivers
An observational study of Autism, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Background: The number of adults with autism is expected to rise significantly in the near future, due to two main reasons: First, a dramatic increase in the estimates of the prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was first introduced during the 1950s, and those… Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Aug 2009
- 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 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: autisem
Who may be able to join
- Autism or autism spectrum disorder
- Understands the informed consent
- Hebrew Speaker
Who cannot join
- Severe acute or chronic illness
- Substance abuse
- In control subjects: Autism or autism spectrum disorder in subject or siblings
- In control subjects: participating sibling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autism: Long Term Course and Impact
Background: The number of adults with autism is expected to rise significantly in the near future, due to two main reasons: First, a dramatic increase in the estimates of the prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was first introduced during the 1950s, and those diagnosed with autism back then are only now entering middle age. Few studies, however, have focused on the outcomes of adult autistic individuals, and very little is known about the course of autism in adulthood and on the familial burden resulting from caring for an autistic adult. We therefore propose to study adult outcomes in autism, and to examine the influence of raising an autistic individual on the parents.
Working hypothesis and aims: The primary objectives of the study are:
- Determine clinical status and functioning of autistic adults.
- Study the influence of raising and caring for an individual with autism on the well-being of the parents.
- Conditions
- Autism
- Keywords
- Autism spectrum disorders, long-term outcomes, caregiver burden, birth cohort, nested case-control study
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Caregiver Burden
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (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.
- More trials run by Sheba Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Raz Gros, MD, Principal investigator, Mental Health Epidemiology & Psychosocial Aspects of Illness, The Gertner Institute for Epidemiology and Health Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367107
- Sponsor's protocol ID
- SHEBA-06-4169-RG-CTIL
- Status last verified
- Feb 2008
- First submitted
- 21 Aug 2006
- Last updated
- 6 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism: Long Term Course and Impact
- ClinicalTrials.gov ID
- NCT00367107
- Acronym / sponsor ID
- SHEBA-06-4169-RG-CTIL
- Conditions
- Autism
- Keywords
- Autism spectrum disorders, long-term outcomes, caregiver burden, birth cohort, nested case-control study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- First posted
- 22 Aug 2006 (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.
Background: The number of adults with autism is expected to rise significantly in the near future, due to two main reasons: First, a dramatic increase in the estimates of the prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was first introduced during the 1950s, and those diagnosed with autism back then are only now entering middle age. Few studies, however, have focused on the outcomes of adult autistic individuals, and very little is known about the course of autism in adulthood and on the familial burden resulting from caring for an autistic adult. We therefore propose to study adult outcomes in autism, and to examine the influence of raising an autistic individual on the parents.
Working hypothesis and aims: The primary objectives of the study are:
- Determine clinical status and functioning of autistic adults.
- Study the influence of raising and caring for an individual with autism on the well-being of the parents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- autisem
Key inclusion criteria (3 listed)
- Autism or autism spectrum disorder
- Understands the informed consent
- Hebrew Speaker
Key exclusion criteria (4 listed)
- Severe acute or chronic illness
- Substance abuse
- In control subjects: Autism or autism spectrum disorder in subject or siblings
- In control subjects: participating sibling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2008.
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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.
Raz Gros, MD principal investigator
Mental Health Epidemiology & Psychosocial Aspects of Illness, The Gertner Institute for Epidemiology and Health Policy Research
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 Sheba 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 3 inclusion and 4 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 Feb 2008. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 Feb 2008.