Clinical trial NCT01430845: Predicting Developmental Disability Type and Mental Retardation Level in Children With General Developmental Delay
Official title: Predicting Developmental Disability Type and Mental Retardation Level in Children Who Were Diagnosed in General Developmental Delay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Global Developmental Delay
Cerebral Palsy
Mental Retardation
Pervasive Developmental Disorders
Keywords: GDD
CP
MR
PDD
ASD
BSID
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-09-08
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: level of Mental retardation in older age
timeFrame: non
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
Study officials:
affiliation: Sheba Medical Center
name: Lidia Gabis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Shefer Shahar, PHD
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Bat Chen Amir, BA
role: STUDY_DIRECTOR
References: