Autism Spectrum DisorderNCT01435733
Parenting a Child With Autism Spectrum Disorder and Marital Status
An observational study of Autism Spectrum Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to investigate whether the presence of a child with Autism Spectrum Disorder places parents at increased risk for divorce. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2011to 1 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Couples who have children with ASD will be recruited to participate in this study from the Weinberg Child Development Center in the Edmond and LilySafra Children'shospital, ShebaMedical Center, Ramat-Gan, Israel. Parents will be contacted through the telephone and provided with a brief explanation about the study. Participation will be voluntary with no monetary compensation. Parents who volunteer to participate will then be presented with a short telephone survey, asking them about their marital status and other variables related to the link between parenting an ASD child and their marital status.
Who may be able to join
- parents to a child with ASD
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Israel1 site
Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
Ramat Gan
About this study
The purpose of this study is to investigate whether the presence of a child with Autism Spectrum Disorder places parents at increased risk for divorce.
Read the detailed description
Autism spectrum disorders (ASDs) are lifelong neurodevelopmental disorders involving a triad of impairments in communication and social reciprocity and increases in repetitive/restricted interests and behaviors. ASD includes: autistic disorder, Asperger's syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), Rett's syndrome, and childhood disintegrative disorder as pervasive developmental disorders (American Psychiatric Association [DSM-IV-TR], 2000).
Few disabilities appear to be more taxing on parents than ASDs.Parents of children with ASD fare worse on a variety of measures of well-being than parents of children without disabilities as well as parents of children with other types of disabilities.
Studies investigating the impact of a child with disabilities, specifically ASD, are inconclusive. However, parents of children with ASD may be at increased risk for divorce due to a variety of personal and disability related factors. In Israel the relationship of having a child with autism on the probability of divorce has not been tested yet. The aim of this study is to profile this relationship and determine the magnitude and directionality of the effect raising ASD children has on the resilience of the institution of marriage and the satisfaction both partners derive. This will be tested using a short telephone survey.
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Divorce
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Parents of children with ASD | Parents with one or more children diagnosed with Autism Spectrum Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower or higher levels of divorce
lower or higher levels of divorce
Measured: not relevant (phone survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study start1 Sep 2011
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Why it stopped: Recruitment Status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lidia Gabis, MD, Principal investigator, Sheba Medical CenterGilad Gal, Ph.D, Principal investigator, Tel Aviv-Yafo Academic CollegeKlara Zislin, BA, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435733
- Sponsor's protocol ID
- SHEBA-11-8552-LG-CTIL
- Status last verified
- Jun 2018
- First submitted
- 15 Sep 2011
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting a Child With Autism Spectrum Disorder and Marital Status
- ClinicalTrials.gov ID
- NCT01435733
- Acronym / sponsor ID
- SHEBA-11-8552-LG-CTIL
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Divorce
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Recruitment Status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Sep 2011
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 19 Sep 2011 (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 purpose of this study is to investigate whether the presence of a child with Autism Spectrum Disorder places parents at increased risk for divorce.
Detailed description
Autism spectrum disorders (ASDs) are lifelong neurodevelopmental disorders involving a triad of impairments in communication and social reciprocity and increases in repetitive/restricted interests and behaviors. ASD includes: autistic disorder, Asperger's syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), Rett's syndrome, and childhood disintegrative disorder as pervasive developmental disorders (American Psychiatric Association [DSM-IV-TR], 2000).
Few disabilities appear to be more taxing on parents than ASDs.Parents of children with ASD fare worse on a variety of measures of well-being than parents of children without disabilities as well as parents of children with other types of disabilities.
Studies investigating the impact of a child with disabilities, specifically ASD, are inconclusive. However, parents of children with ASD may be at increased risk for divorce due to a variety of personal and disability related factors. In Israel the relationship of having a child with autism on the probability of divorce has not been tested yet. The aim of this study is to profile this relationship and determine the magnitude and directionality of the effect raising ASD children has on the resilience of the institution of marriage and the satisfaction both partners derive. This will be tested using a short telephone survey.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents of children with ASD | – | –Parents with one or more children diagnosed with Autism Spectrum Disorder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Couples who have children with ASD will be recruited to participate in this study from the Weinberg Child Development Center in the Edmond and LilySafra Children'shospital, ShebaMedical Center, Ramat-Gan, Israel. Parents will be contacted through the telephone and provided with a brief explanation about the study. Participation will be voluntary with no monetary compensation. Parents who volunteer to participate will then be presented with a short telephone survey, asking them about their marital status and other variables related to the link between parenting an ASD child and their marital status.
Key inclusion criteria (1 listed)
- parents to a child with ASD
Key exclusion criteria (1 listed)
- none
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
lower or higher levels of divorce
Time frame: not relevant (phone survey)
lower or higher levels of divorce
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Lidia Gabis, MD principal investigator
Sheba Medical Center
Gilad Gal, Ph.D principal investigator
Tel Aviv-Yafo Academic College
Klara Zislin, BA study director
Sheba Medical Center
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 Disorder, 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 1 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: paused, as of the sponsor's last update on 2 Jul 2018. 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.
What does the primary outcome measure?
lower or higher levels of divorce (time frame: not relevant (phone survey)). 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 2 Jul 2018.