Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus
NCT Number: NCT06488469
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: BEHAVIORAL: Psychological Interventions for children and adolescents
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|Believers Church Medical College, Thiruvalla, Kerala, India.
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-30
Locations: Believers Church Medical College, Tiruvalla, Kerala, 689 103, India

Summary:
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.

Primary Outcome Measures: Cognitive Functioning (Neuropsychological domain level), Change in cognitive functioning as assessed by as compared to treatment as usual group measured by NIMHANS Neuropsychological Battery, Baseline and after six months' intervention|Cognitive Functioning (Index level, ), 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, Baseline and after six months' intervention|Cognitive Functioning (Index level,perceptual reasoning index ), 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, Baseline and after six months' intervention|Cognitive Functioning (auditory and verbal learning), Change in cognitive functioning (auditory and verbal learning) as assessed by Neuropsychological domain level, .as compared to treatment as usual group, Baseline and after six months' intervention|Cognitive Functioning (memory and learning), Change in cognitive functioning (memory and learning) as assessed by Neuropsychological domain level, .as compared to treatment as usual group, Baseline and after six months' intervention|Cognitive Functioning (language), Change in cognitive functioning (language) as assessed by Neuropsychological domain level, .as compared to treatment as usual group, Baseline and after six months' intervention|Behavioural Assessment, 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, Baseline and after intervention|Parental Attitude, 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, Baseline and after six months' intervention