Autism Spectrum DisordersNCT00695812
The Development of Younger Siblings of Children With Autism Now at 10 Years of Age
An observational study of Autism Spectrum Disorders, run by Shaare Zedek Medical Center.
Trial summary
Background: Autism is a complex developmental disorder involving difficulties in verbal and nonverbal communication, social-emotional functioning, and markedly restricted interests and activities. Read more about this study
- Who is it for?
- Ages 10 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Sep 2011
- 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 10 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The participants in the SIBS-A and SIBS-TD groups, who are now reaching the age of 10 years, participated in the longitudinal study and were seen at the ages of 4, 14, 24, 36, 54 months and 7 years. The SIBS-A group (n = 42) comprises children who have an older sibling with autism. All probands were diagnosed using the Autism Diagnostic Observation Schedule (Lord, Rutter, DiLavore \& Risi, 2002) and/or the Autism Diagnostic Interview - Revised (ADI-R; Lord, Rutter, \& Le Couteur, 1994). Families were recruited through treatment centers, special schools, the national organization for children with autism in Israel, and through families of children with autism. The SIBS-TD group (n = 62) comprises children who have an older sibling with typical development and who participated in the longitudinal study. Families were recruited from maternity wards in Jerusalem. (more information is available in Yirmiya et al., 2006).
Who may be able to join
- A group comprised intact families who had a child with autism.
- Intact families with a newborn and an older child who exhibited typical development with no history of any learning and/or emotional difficulties according to parental report
Who cannot join
None listed.
About this study
Background: Autism is a complex developmental disorder involving difficulties in verbal and nonverbal communication, social-emotional functioning, and markedly restricted interests and activities. Strong evidence from research conducted with family members of children with autism supports the role of genetic factors in its etiology. Thus, some family members are characterized by the broad autism phenotype (BAP) which involves a clinical picture of milder but qualitatively similar difficulties.
Working hypothesis and aims: Researchers recently initiated prospective longitudinal studies investigating the early developmental profiles of young siblings of children with autism (SIBS-A). Such longitudinal SIBS-A study is currently conducted at the Hebrew University and includes the oldest siblings studied to date. Our main aim is to identify siblings who manifest any autism or BAP characteristics.
Read more
Methods: Two groups, SIBS-A (n = 42) and siblings of children with typical development (SIBS-TD, n = 62), were seen at ages 4, 14, 24, 36, 54 months and 7 years. We plan to continue the investigation at age 10 years, a time when school related abilities and social/emotional competences are more consolidated and to investigate the developmental trajectories of children's abilities from age 4 months to 10 years using growth curve analyses.
Expected results: We expect that compared to SIBS-TD, significantly more 10-year-old SIBS-A will display difficulties related to ASD or BAP related difficulties. We also expect to identify different patterns of stability and/or change in the development of children's abilities from age 4 months to 10 years, between the two groups.
Importance: This study provides a useful approach for the examination of the main research hypothesis regarding the development of SIBS-A. One of the main advantages of using the growth curve analysis is the identification of early predictive markers for future development.
Probable implications to Medicine: This research has significant implication for early identification and the search into the causes of autism and the BAP, as well as for implementation of early treatment and prevention programs. By highlighting expressions of ASD and the BAP in siblings, we may identify early clinically predictive behavioral markers associated with their onset and contribute to the investigation of underlying genetics mechanisms.
- Conditions
- Autism Spectrum Disorders
- Keywords
- Neurodevelopmental disorders, Autism Spectrum Disorders, Broader autism phenotype, Siblings, Cognitive language and social emotional development, to identify siblings who manifest any autism or broader autism phenotype characteristics
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders
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 |
|---|---|---|
| 1 | Siblings of children with Autism | |
| 2 | Siblings of children with typical development |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
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.
- 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695812
- Sponsor's protocol ID
- Siblings Autism.ctil
- Status last verified
- Jun 2008
- First submitted
- 10 Jun 2008
- Last updated
- 12 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Younger Siblings of Children With Autism Now at 10 Years of Age
- ClinicalTrials.gov ID
- NCT00695812
- Acronym / sponsor ID
- Siblings Autism.ctil
- Conditions
- Autism Spectrum Disorders
- Keywords
- Neurodevelopmental disorders, Autism Spectrum Disorders, Broader autism phenotype, Siblings, Cognitive language and social emotional development, to identify siblings who manifest any autism or broader autism phenotype characteristics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Sep 2008
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 12 Jun 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.
Background: Autism is a complex developmental disorder involving difficulties in verbal and nonverbal communication, social-emotional functioning, and markedly restricted interests and activities. Strong evidence from research conducted with family members of children with autism supports the role of genetic factors in its etiology. Thus, some family members are characterized by the broad autism phenotype (BAP) which involves a clinical picture of milder but qualitatively similar difficulties.
Working hypothesis and aims: Researchers recently initiated prospective longitudinal studies investigating the early developmental profiles of young siblings of children with autism (SIBS-A). Such longitudinal SIBS-A study is currently conducted at the Hebrew University and includes the oldest siblings studied to date. Our main aim is to identify siblings who manifest any autism or BAP characteristics.
Methods: Two groups, SIBS-A (n = 42) and siblings of children with typical development (SIBS-TD, n = 62), were seen at ages 4, 14, 24, 36, 54 months and 7 years. We plan to continue the investigation at age 10 years, a time when school related abilities and social/emotional competences are more consolidated and to investigate the developmental trajectories of children's abilities from age 4 months to 10 years using growth curve analyses.
Expected results: We expect that compared to SIBS-TD, significantly more 10-year-old SIBS-A will display difficulties related to ASD or BAP related difficulties. We also expect to identify different patterns of stability and/or change in the development of children's abilities from age 4 months to 10 years, between the two groups.
Importance: This study provides a useful approach for the examination of the main research hypothesis regarding the development of SIBS-A. One of the main advantages of using the growth curve analysis is the identification of early predictive markers for future development.
Probable implications to Medicine: This research has significant implication for early identification and the search into the causes of autism and the BAP, as well as for implementation of early treatment and prevention programs. By highlighting expressions of ASD and the BAP in siblings, we may identify early clinically predictive behavioral markers associated with their onset and contribute to the investigation of underlying genetics mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Siblings of children with Autism |
| 2 | – | –Siblings of children with typical development |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The participants in the SIBS-A and SIBS-TD groups, who are now reaching the age of 10 years, participated in the longitudinal study and were seen at the ages of 4, 14, 24, 36, 54 months and 7 years. The SIBS-A group (n = 42) comprises children who have an older sibling with autism. All probands were diagnosed using the Autism Diagnostic Observation Schedule (Lord, Rutter, DiLavore \& Risi, 2002) and/or the Autism Diagnostic Interview - Revised (ADI-R; Lord, Rutter, \& Le Couteur, 1994). Families were recruited through treatment centers, special schools, the national organization for children with autism in Israel, and through families of children with autism. The SIBS-TD group (n = 62) comprises children who have an older sibling with typical development and who participated in the longitudinal study. Families were recruited from maternity wards in Jerusalem. (more information is available in Yirmiya et al., 2006).
Key inclusion criteria (2 listed)
- A group comprised intact families who had a child with autism.
- Intact families with a newborn and an older child who exhibited typical development with no history of any learning and/or emotional difficulties according to parental report
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.
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 12 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders, run by Shaare Zedek Medical Center.
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 2 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 12 Jun 2008. 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?
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 12 Jun 2008.