跳至主要内容
临床试验/CTRI/2024/11/076310
CTRI/2024/11/076310尚未招募不适用

Assessment of emotional and behavioral profile of children with Intellectual Disability

NA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NA
入组人数
30
试验地点
1
主要终点
Behaviour profile will be determined based on SDQ into Normal, Borderline

研究概览

简要总结

Globally the prevalence of emotional and behavioural problems are increase.It is already known that children with developmental problems may have up to 4 times the likelihood of having a concurrent mental health diagnosis compared with children who are typically developing. These problems not only impact on the daily functioning of children and put a strain on family but also hinder their learning and further development. Early identification and management of behavioural problems will help improve the quality of life and outcome. With this study we aim to identify emotional and behavioural problems which coexist in children with intellectual disability. We propose to conduct a prospective observational cross sectional study involving 30 children with Intellectual Disability aged between 2 years to 15 years presenting to Department of Paediatrics unit 1, Kasturba Hospital, Manipal. Institutional ethics committee approval has been obtained prior to the commencement of the study. The study will be registered under CTRI. A written informed consent will be obtained from care givers of each child prior to the recruitment into the study, since children with intellectual disability are being enrolled assent form will not be signed by them. A detailed history of presenting illness including developmental history will be recorded. Developmental examination and VSMS of each child will be done by the investigator. SDQ parent questionnaire will be filled by the parents. Impact questionnaire will be administered by the examiner. Scoring of SDQ questionnaires will be done by the examiners and results will be noted. All the data will be compiled and subjected to statistical analysis using mean, paired t-test, and simple linear regression, and compilation of the result will be done.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • VSMS Score of 70 or below.

排除标准

  • VSMS Score 70-84 Children not accompanied by primary caregiver.

结局指标

主要结局

Behaviour profile will be determined based on SDQ into Normal, Borderline

时间窗: 6 months

and Abnormal, which will be then compared with VSMS subgroups.

时间窗: 6 months

次要结局

  • measurement of impact of behaviour difficulty on child’s daily functioning.(6 months)

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Ashima Mehta

Kasturba Medical College, Manipal

研究点 (1)

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