Mental RetardationNCT02214745
Demographic Characteristics of Children Suffering From Mental Retardation or Cerebral Palsy in the Israeli Arab Community
An observational study of Mental Retardation and Cerebral Palsy, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
To evaluate the demographic characteristics of patients suffering from mental retardation or cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and will be distributed amongst this population in order to identify these characteristics. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Mental Retardation, Cerebral Palsy
- What is being tested?
- Questionnaire
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Mar 2017
- 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: Israeli Arab and Israeli Jewsih children suffering from mental retardation or cerebral palsy who have presented at the Child Development Institute at the Hillel Yaffe Medical Center.
Who may be able to join
- cerebral palsy
- mental retardation
- Israeli Arab
- Israeli Jewish
Who cannot join
- all others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Muhammad Mahajnah, MD, PhD, 972-5-624-6959, mohamedm@hy.health.gov.il
About this study
To evaluate the demographic characteristics of patients suffering from mental retardation or cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and will be distributed amongst this population in order to identify these characteristics.
- Conditions
- Mental Retardation, Cerebral Palsy
- Being tested
- Questionnaire
- Keywords
- Israeli Arab population, Israeli/ethnology
- Medical subject headings
- Intellectual Disability, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire developed for this purpose by the investigators
| Study group | Role | What they receive |
|---|---|---|
| Mentally retarded Israeli Arab children | Not described Receives: Other: Questionnaire | |
| Israeli Arab children with cerebral palsy | Not described Receives: Other: Questionnaire | |
| Israeli Jewish children with cerebral palsy | Not described Receives: Other: Questionnaire | |
| Mentally retarded Israeli Jewish children | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Characteristics
Demographic characteristics will be identified through a questionnaire and will be compared with control groups.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental RetardationStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Muhammad Mahajnah, MD, PhD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214745
- Sponsor's protocol ID
- 0032-14-HYMC
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic Characteristics of Children Suffering From Mental Retardation or Cerebral Palsy in the Israeli Arab Community
- ClinicalTrials.gov ID
- NCT02214745
- Acronym / sponsor ID
- 0032-14-HYMC
- Conditions
- Mental Retardation, Cerebral Palsy
- Keywords
- Israeli Arab population, Israeli/ethnology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 12 Aug 2014 (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.
To evaluate the demographic characteristics of patients suffering from mental retardation or cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and will be distributed amongst this population in order to identify these characteristics.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mentally retarded Israeli Arab children | – | Other: Questionnaire |
| Israeli Arab children with cerebral palsy | – | Other: Questionnaire |
| Israeli Jewish children with cerebral palsy | – | Other: Questionnaire |
| Mentally retarded Israeli Jewish children | – | Other: Questionnaire |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Israeli Arab and Israeli Jewsih children suffering from mental retardation or cerebral palsy who have presented at the Child Development Institute at the Hillel Yaffe Medical Center.
Key inclusion criteria (4 listed)
- cerebral palsy
- mental retardation
- Israeli Arab
- Israeli Jewish
Key exclusion criteria (1 listed)
- all others
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 |
|---|---|---|
| QuestionnaireQuestionnaire developed for this purpose by the investigators | Other | Israeli Arab children with cerebral palsy, Israeli Jewish children with cerebral palsy, Mentally retarded Israeli Arab children, Mentally retarded Israeli Jewish children |
Primary outcome
Demographic Characteristics
Time frame: One day
Demographic characteristics will be identified through a questionnaire and will be compared with control groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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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.
Muhammad Mahajnah, MD, PhD principal investigator
Hillel Yaffe 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 Mental Retardation and Cerebral Palsy, 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 4 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: status not confirmed, as of the sponsor's last update on 12 Aug 2014. 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 (972-5-624-6959, 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?
Demographic Characteristics (time frame: One day). 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 12 Aug 2014.