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

NCT ID: NCT01430845

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-01
• Study Completion Date: 2015-12-01

Brief Summary

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).

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.

Conditions

Global Developmental Delay; Cerebral Palsy; Mental Retardation; Pervasive Developmental Disorders

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lidia Gabis, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Shefer Shahar, PHD

Role: STUDY_DIRECTOR

Sheba Medical Center

Bat Chen Amir, BA

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-11-8458-LG-CTIL

Identifier Type: -

Identifier Source: org_study_id