Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus

Sponsor
University of Pittsburgh
Study ID
NCT06488469
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Psychological Interventions for children and adolescents — BEHAVIORAL
    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 Psychological Interventions for Parents/ Caregivers: * Parent management techniques- Identification of problem behaviors/deficit * Education on Dysfunctional attitude and their effects Psycho-education for Children could be delivered best in Combined with Health Education and Nutritional education leading to dietary modifications. * Individualized Treatment targets and Resetting targets

Study Details

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.

Key Dates

First listed
Jul 5, 2024
Start date
Dec 1, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Cognitive Functioning (Neuropsychological domain level) [ Time Frame: Baseline and after six months' intervention ]

Central Contacts

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