The Effect of a Multi-domain Intervention on the Behaviour Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus- A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Parental Attitude
研究概览
简要总结
The study is designed to explore if a multi-pronged intervention strategy comprising of Psychological Interventions, Dietary Modifications, Targeted therapy and Counselling on Parental Attitude would bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.
详细描述
As per American Diabetes Association on Standards of Medical Care in Diabetes-2020, Continuous glucose monitoring (CGM) should be considered in all children and adolescents with Type 1 Diabetes Mellitus to look out for Hypoglycemia Unawareness. But unfortunately, it is not done as a routine practice in India due to financial constraints. So, the aim is to explore the behavior and cognition in children with Hypoglycemia Unawareness and to find out if a multipronged strategy consisting of Psychological Interventions, Dietary Modifications, Targeted therapy and Counseling on Parental Attitude to bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.
Those children with documented Hypoglycemia Unawareness will be subjected to Behavioral and Cognition Testing using Child Behavior Checklist , Modified Mini-MMSE and a part of the NIMHANS neuropsychological battery. Parents or caregivers (especially mother) of children with Hypoglycemia unawareness will be assessed for parental attitude towards their children.
All children with Hypoglycemia Unawareness and their parents will receive the multi-domain interventions by a certified Child Psychologist in the Psychiatric Department and Trained Diabetic Educators in the Endocrinology Dept. as per the prepared modules.
Psychological Interventions for children and adolescents:
- Behavioral modifications using Functional Analysis and Parent Management Techniques
- Illness Management behavior - Motivational Interviewing, Cognitive Therapy to identify thinking errors posing challenges to self-management, Behavioral Modification to enhance self-management of illness, Solution focused therapy to manage identified barriers in illness -management
- Managing emotional problems- Cognitive Behavioral Therapy techniques
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children should be between 6-16 years of age.
- •Children must be having Hypoglycemia Unawareness as documented by Continuous Glucose Monitoring. (Blood sugar <70 mg/dl without symptoms)
- •Children must be on treatment with Insulin for a minimum period of 6 months
- •The care giver/parent must give written informed consent for the child and himself/herself and the child should give assent.
排除标准
- •Children with known psychiatric disorders.
- •Children who are on steroids and
- •Children with documented Learning Disability from a certified psychologist.
研究组 & 干预措施
intervention
The interventions will be provided at regular intervals of 2 months and adherence to the interventions will be monitored. The children along with the caregivers will attend the Endocrinology OPD where they will be educated as per prepared modules by the diabetic educators and will be monitored for adherence to diet and insulin. They will also be directed to the Child Psychologist to give module- based interventions. The interventions will be provided for a period of 6 months. Follow up of patients for reinforcement of interventions will happen on 2-monthly basis.
干预措施: Psychological Interventions for children and adolescents (Behavioral)
Usual Care
Routine standard of care is given to all patients with Hypoglycemia unawareness, irrespective of the randomized group to which they belong. This include treatment of hypoglycaemia, mandatory avoidance of hypoglycaemia for 2 weeks, Review of drugs and diet every 3 months (which is routinely done at our centre) and exploring the causes of hypoglycaemia. The control group will receive education on Dietary modification, advise on individualized targets and warning signs of hypoglycemia.
干预措施: Psychological Interventions for children and adolescents (Behavioral)
结局指标
主要结局
Parental Attitude
时间窗: Baseline and after six months' intervention
Change in parental Attitude in the domain scores on 8 domains- 1. Overprotection 2. Acceptance 3. Rejection 4. Permissiveness 5. Communication 6. Attitude towards education 7. Home management 8. Hostility
Cognitive Functioning (Neuropsychological domain level)
时间窗: Baseline and after six months' intervention
Change in cognitive functioning as assessed by as compared to treatment as usual group measured by NIMHANS Neuropsychological Battery
Cognitive Functioning (Index level,perceptual reasoning index )
时间窗: Baseline and after six months' intervention
Change in cognitive functioning Index level, percepual reasoning index() as assessed by Neuropsychological domain level, as compared to treatment as usual group measured by NIMHANS Neuropsychological Battery
Cognitive Functioning (memory and learning)
时间窗: Baseline and after six months' intervention
Change in cognitive functioning (memory and learning) as assessed by Neuropsychological domain level, .as compared to treatment as usual group
Cognitive Functioning (language)
时间窗: Baseline and after six months' intervention
Change in cognitive functioning (language) as assessed by Neuropsychological domain level, .as compared to treatment as usual group
Cognitive Functioning (Index level, )
时间窗: Baseline and after six months' intervention
Change in cognitive functioning Index level, visuo comprehension index() as assessed by Neuropsychological domain level, as compared to treatment as usual group measured by NIMHANS Neuropsychological Battery
Cognitive Functioning (auditory and verbal learning)
时间窗: Baseline and after six months' intervention
Change in cognitive functioning (auditory and verbal learning) as assessed by Neuropsychological domain level, .as compared to treatment as usual group
Behavioural Assessment
时间窗: Baseline and after intervention
Change in behavioural dimensions such as 1. anxious / depressed, 1. withdrawn/ depressed, 2. somatic complaints, 3. social problems, 4. thought problems, 5. attention problems, 6. rule-breaking problems 7. aggressive behavior problems as measured by Child Behaviour checklist
次要结局
未报告次要终点
研究者
Vishwajit Nimgaonkar, MD PhD
Professor
University of Pittsburgh