Autism Spectrum DisordersNCT00801554
Autism Spectrum Disorders (ASD) Characterization Study
An observational study of Autism Spectrum Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The overarching aim of the study is to characterize children and adults with ASDs, and compare them with age-matched controls in relation to their functioning in family, academic, employment, and social spheres. Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Apr 2010
- 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 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and adults with ASDs. Controls: healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder.
Who may be able to join
- Age: 6-60 years old
- For subjects who have ASD: Meet DSM-IV PDD criteria based on clinical assessment including PDD module of structured interview
- For subjects who have ASD: One parent/guardian available for interviews about each subject. If a parent or guardian is not available, a reliable adult reporter identified by the subject available for an interview
- Full-scale IQ of above 80
Who cannot join
- Major sensorimotor handicaps (e.g. deafness, blindness)
- Any severely unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, substance use disorders (alcohol or drugs) that would require in-patient hospitalization.
- Inadequate command of the English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: A Characterization Study of Individuals With Autism Spectrum Disorders
The overarching aim of the study is to characterize children and adults with ASDs, and compare them with age-matched controls in relation to their functioning in family, academic, employment, and social spheres. Subjects will be comprehensively assessed in multiple non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial instruments.
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism Spectrum Disorder, ASD, Autism, Asperger's Syndrome, PDD-NOS, Pervasive Developmental Disorders- Not Otherwise Specified, Adults, Children
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASD | Children and adults with Autism Spectrum Disorders. | |
| Non-ASD | Healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder in their lifetime. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD.
Measured: single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801554
- Sponsor's protocol ID
- 2007-P-001951
- Status last verified
- Oct 2013
- First submitted
- 2 Dec 2008
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Characterization Study of Individuals With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00801554
- Acronym / sponsor ID
- 2007-P-001951
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism Spectrum Disorder, ASD, Autism, Asperger's Syndrome, PDD-NOS, Pervasive Developmental Disorders- Not Otherwise Specified, Adults, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 3 Dec 2008 (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.
The overarching aim of the study is to characterize children and adults with ASDs, and compare them with age-matched controls in relation to their functioning in family, academic, employment, and social spheres. Subjects will be comprehensively assessed in multiple non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial instruments.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD | – | –Children and adults with Autism Spectrum Disorders. |
| Non-ASD | – | –Healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder in their lifetime. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and adults with ASDs. Controls: healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder.
Key inclusion criteria (4 listed)
- Age: 6-60 years old
- For subjects who have ASD: Meet DSM-IV PDD criteria based on clinical assessment including PDD module of structured interview
- For subjects who have ASD: One parent/guardian available for interviews about each subject. If a parent or guardian is not available, a reliable adult reporter identified by the subject available for an interview
- Full-scale IQ of above 80
Key exclusion criteria (3 listed)
- Major sensorimotor handicaps (e.g. deafness, blindness)
- Any severely unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, substance use disorders (alcohol or drugs) that would require in-patient hospitalization.
- Inadequate command of the English language.
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
Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD.
Time frame: single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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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.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
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 Spectrum Disorders, run by Massachusetts General Hospital 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Oct 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD. (time frame: single time point). 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 22 Oct 2013.