- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01430845
Predicting Developmental Disability Type and Mental Retardation Level in Children With General Developmental Delay
Predicting Developmental Disability Type and Mental Retardation Level in Children Who Were Diagnosed in General Developmental Delay
Study Overview
Status
Detailed Description
The purpose of this study is to find the relationship between the stage and quality of developmental delay at a young age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders). We assume that analysis of developmental subtests can show the developmental direction of the child and predict his later diagnosis. The developmental test which is chosen for this purpose is the BSID which is a comprehensive and worldwide developmental test. In addition, we want to find the correlation between the developmental delays in early age and the intellectual functioning in the future. We assume that through analyzing the subtests of developmental tests we will succeed in predicting the expected cognitive level (IQ).
Medical files of participating children will be analyzed. The files will be sorted and only those of GDD diagnosis containing BSID test data will be selected. The performances of the BSID test and the current diagnosis of the children will be recorded. A trained researcher will process the BSID data and build a database which will include the findings of the test, the current diagnosis of the child and the level of MR, in case the child suffers from MR (only or comorbidly). In order to test the research assumptions appropriate statistic tests will be done using the statistical program SPSS version 17.
This study has important implications. Findings which show that the developmental tests are effective tools, not only to evaluate general developmental delay, but as auxiliary tools for diagnosing and predicting the type of disability and level of retardation. These findings are a breakthrough in the diagnostic field. In addition, the ability to predict the type of disability and level of mental retardation by a developmental test that is used so widely allows early intervention, and as has been widely proven, the earlier the intervention, the better the outcome.
In addition, a vast range of people will benefit from the findings. Professionals such as doctors, psychologists and paramedical therapists, government bodies and community resources that can design and build a support system and services for the child and his family. Most importantly, the family of the diagnosed child and the child himself will be able to prepare themselves to the new reality and design their life accordingly.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ramat-Gan, Israel
- Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- GDD diagnosis in two axis' at least
- BSID test in its second or third version
Exclusion Criteria:
- If not all of the data is available for all of the assessments
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
level of Mental retardation in older age
Time Frame: non
|
non
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shefer Shahar, PHD, Sheba Medical Center
- Study Director: Bat Chen Amir, BA, Sheba Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Brain Damage, Chronic
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Cerebral Palsy
- Autism Spectrum Disorder
- Developmental Disabilities
- Intellectual Disability
Other Study ID Numbers
- SHEBA-11-8458-LG-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey