Pervasive Developmental DisorderNCT00531830
Assessment of Factors Which Predict Improvement in Children With PDD After a Year of Integrative Therapy
An observational study of Pervasive Developmental Disorder, run by BeerYaakov Mental Health Center.
Trial summary
The aim of the current research is to assess the efficiency of the Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel. An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic… Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pervasive Developmental Disorder
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with PDD
- Children aged from 2 years to 6 years
Who cannot join
- Children with severe retardation
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the current research is to assess the efficiency of the Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.
An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.
Read the detailed description
Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.
An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.
- Conditions
- Pervasive Developmental Disorder
- Keywords
- children with PDD
- Medical subject headings
- Child Development Disorders, Pervasive
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 | Preschool children with PDD | |
| 2 | Preschool children without PDD |
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 completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pervasive Developmental DisorderStudies 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 60 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, IsraelBeatriz Priel, Prof., Study director, Ben Gurion University, Beer-ShevaAlexander Rejba, M.A., Study chair, Ben-Gurion University, Beer-Sheva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531830
- Sponsor's protocol ID
- Children with PDD -31CTIL
- Status last verified
- Sep 2007
- First submitted
- 18 Sep 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Factors Which Predict Improvement in Children With PDD After a Year of Integrative Therapy
- ClinicalTrials.gov ID
- NCT00531830
- Acronym / sponsor ID
- Children with PDD -31CTIL
- Conditions
- Pervasive Developmental Disorder
- Keywords
- children with PDD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BeerYaakov Mental Health CenterOther government
- Study start
- Sep 2007
- Study completion
- Sep 2011 (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 aim of the current research is to assess the efficiency of the Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.
An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.
Detailed description
Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.
An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Preschool children with PDD |
| 2 | – | –Preschool children without PDD |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with PDD
- Children aged from 2 years to 6 years
Key exclusion criteria (1 listed)
- Children with severe retardation
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 26 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. principal investigator
Mental health unit for preschoolers, Ashdod, Israel
Beatriz Priel, Prof. study director
Ben Gurion University, Beer-Sheva
Alexander Rejba, M.A. study chair
Ben-Gurion University, Beer-Sheva
Questions about this trial
What is this clinical trial studying?
An observational study of Pervasive Developmental Disorder, run by BeerYaakov Mental Health 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 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 26 Sep 2007. 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?
Contact Beatriz Priel, Prof. (972-8-6472078, bpriel@gmail.com), 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 26 Sep 2007.