Trial record 3 of 185 for:    Open Studies | "Developmental Disabilities"

Predicting Developmental Disability Type and Mental Retardation Level in Children With General Developmental Delay

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01430845
First received: September 7, 2011
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to find the relationship between the stage and quality of developmental delay during infancy and toddler age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).


Condition
Global Developmental Delay
Cerebral Palsy
Mental Retardation
Pervasive Developmental Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Predicting Developmental Disability Type and Mental Retardation Level in Children Who Were Diagnosed in General Developmental Delay

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • level of Mental retardation in older age [ Time Frame: non ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will be conducted at the Child Development Center in Tel-Hashomer hospital (Ramat-Gan, Israel). The target population is all children who were diagnosed at the hospital with GDD (in two axis' at least) between the years 2003 to 2005. They must also have undergone the BSID test in its second or third version. The data must be available on all assessments (N~150). The children were 1.5-3 years old at diagnosis and diagnosed by a doctor and psychologist. Today these children are 5-7 years old. Some of them are still being treated in Tel-Hashomer. The children live all over the country

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430845

Locations
Israel
Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer Recruiting
Ramat-Gan, Israel
Contact: Lidia Gabis, MD    +972-3-5302236    lidia.gabis@sheba.health.gov.il   
Principal Investigator: Lidia Gabia, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Lidia Gabis, MD Sheba Medical Center
Study Director: Shefer Shahar, PHD Sheba Medical Center
Study Director: Bat Chen Amir, BA Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01430845     History of Changes
Other Study ID Numbers: SHEBA-11-8458-LG-CTIL
Study First Received: September 7, 2011
Last Updated: March 1, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
GDD
CP
MR
PDD
ASD
BSID

Additional relevant MeSH terms:
Developmental Disabilities
Child Development Disorders, Pervasive
Cerebral Palsy
Intellectual Disability
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014