跳至主要内容
临床试验/CTRI/2024/05/067951
CTRI/2024/05/067951尚未招募4 期

Effect of a Multidomain Intervention on the Behaviour Problems and Cognition in children with Hypoglycemia Unawareness in Type-1 Diabetes Mellitus-A Pilot Study

Psychiatric Research Infrastructure for Intervention and Implementation in India (PRIIIA)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Behavior and cognition in children with TYpe-1

研究概览

简要总结

The bigger study on the same topic with the WISC-4 Cognition assessment tool, more objectives, larger sample size and  2 year long study has been approved by CTRI (CTRI/2024/03/063628). This will be a pilot study on only 44 patients, using readily available cognition assessment tool (Modified Mini-Mental State Examination) and for a shorter duration of 6 months.

I would like to focus on Behavioral and Cognitive Functions in Children with Young Onset Diabetes Mellitus (predominantly Type-1 Diabetes Mellitus) with a special interest in those who have Hypoglycemia Unawareness or Impaired Awareness of Hypoglycemia. I would like to implement certain structured interventions which could be beneficial in preventing behavioral and cognitive decline in such children. If these interventions prove to be beneficial, we would implement screening for Hypoglycemia Unawareness, Behavioral Screening, and Cognitive Screening for all children with Young Onset Diabetes Mellitus and then provide them with tailored interventions in the form of Psychotherapy for Children and Parents, Diabetes Education and Dietary Interventions. All these interventions when given to children and their parents in a structured, regular, and balanced manner would reduce behavioral problems and cognitive decline.

The Govt. of India and ICMR have initiated steps to curb Type-1 Diabetes. It also established a registry in 2006 named the Young Diabetes Registry. The Govt. of Kerala has started the ‘MITTAYI’ program for early identification, comprehensive treatment and all necessary support for children and Adolescents with Type-1 Diabetes Mellitus. So, if our work proves to be beneficial, we can incorporate our early intervention strategies to tackle behavioral and cognitive problems in all such children, at the State level.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • Children must be on treatment with Insulin for a minimum period of 6 months.

排除标准

  • Children with known psychiatric disorders.
  • Children with known intellectual disability.

结局指标

主要结局

Behavior and cognition in children with TYpe-1

时间窗: Behavior and cognition in children with TYpe-1 | Diabetes Mellitus at the start of the study and at the end of 6 months.

DM before and after Multi-domain interventions.

时间窗: Behavior and cognition in children with TYpe-1 | Diabetes Mellitus at the start of the study and at the end of 6 months.

次要结局

  • Prevalence of Hypoglycemia Unawareness(at the end of the screening 2-3 months)

研究者

发起方
Psychiatric Research Infrastructure for Intervention and Implementation in India (PRIIIA)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sangeetha Merrin Varghese

Believers Church Medical College Hospital, Kerala

研究点 (1)

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