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Completed

NCT Number: NCT01430845

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. level of Mental retardation in older age

    Time frame: non

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

Predicting Developmental Disability Type and Mental Retardation Level in Children Who Were Diagnosed in General Developmental Delay

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 8, 2011
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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