Feeding and Eating Disorders of ChildhoodNCT00531648
Relationships Between Toddlers With Feeding Disorder and SPD and Their Parents
An observational study of Feeding and Eating Disorders of Childhood and Developmental Disabilities, run by BeerYaakov Mental Health Center at 1 site in Israel.
Trial summary
The researched attends to observe the relationships between toddlers that were diagnosed as SPD and as having feeding disorder (by DSM-R-IV)and their parents. Read more about this study
- Who is it for?
- Ages 12 to 30 months
- Conditions the study is for
- Feeding and Eating Disorders of Childhood, Developmental Disabilities
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Nov 2008
- 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 12 to 30 months
- All sexes
- Child
Who may be able to join
- Toddlers aged between one year to two and a half years
- Toddlers diagnosed as SPD by occupational therapist
- Toddlers diagnosed as having feeding disorder by psychiatric physician according to DSM-R-IV
- Toddlers that are normally developed as reported by pediatrician
Who cannot join
- Compliant families
- Toddlers with poor health
Trial locations and contacts
1 site in 1 country.
Irit Orian, M.D. contact
Israel1 site
Mental health unit for preschoolers
Ashdod
Inbal Heimann, B.A., 972-54-5698055, inbal.heimann@gmail.com
About this study
Official title: The System of Relationships Between Parents and Their Toddlers, With Eating Disorders and Sensory Processing Disorders Within Meal and Play Situations
The researched attends to observe the relationships between toddlers that were diagnosed as SPD and as having feeding disorder (by DSM-R-IV)and their parents.
- Keywords
- Toddlers that having feeding disorders and SPD
- Medical subject headings
- Feeding and Eating Disorders of Childhood, Developmental Disabilities
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 | Families with toddlers that having feeding disorders and SPD |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startSep 2007
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeerYaakov Mental Health Center
- Sponsor type
- Other government
- Investigators
- Irit Orian, M.D., Principal investigator, Mental health unit for preschoolers, Ashdod, IsraelInbal Heimann, B.A., Study director, Mental health unit for preschoolers, Ashdod, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531648
- Sponsor's protocol ID
- Feeding disorder-33CTIL
- Status last verified
- Sep 2007
- First submitted
- 18 Sep 2007
- Last updated
- 19 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The System of Relationships Between Parents and Their Toddlers, With Eating Disorders and Sensory Processing Disorders Within Meal and Play Situations
- ClinicalTrials.gov ID
- NCT00531648
- Acronym / sponsor ID
- Feeding disorder-33CTIL
- Keywords
- Toddlers that having feeding disorders and SPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- BeerYaakov Mental Health CenterOther government
- Study start
- Sep 2007
- Study completion
- Nov 2008 (estimated)
- First posted
- 19 Sep 2007 (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 researched attends to observe the relationships between toddlers that were diagnosed as SPD and as having feeding disorder (by DSM-R-IV)and their parents.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Families with toddlers that having feeding disorders and SPD |
Who may qualify
- Ages
- 12 to 30 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- Toddlers aged between one year to two and a half years
- Toddlers diagnosed as SPD by occupational therapist
- Toddlers diagnosed as having feeding disorder by psychiatric physician according to DSM-R-IV
- Toddlers that are normally developed as reported by pediatrician
Key exclusion criteria (2 listed)
- Compliant families
- Toddlers with poor health
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 19 Sep 2007.
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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.
Irit Orian, M.D. contact
Irit Orian, M.D. principal investigator
Mental health unit for preschoolers, Ashdod, Israel
Inbal Heimann, B.A. study director
Mental health unit for preschoolers, Ashdod, Israel
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 Feeding and Eating Disorders of Childhood and Developmental Disabilities, run by BeerYaakov Mental Health 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 2 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 19 Sep 2007. 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 Irit Orian, M.D. (972-8-8559826), or a site near the patient. 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 19 Sep 2007.