Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-19
Brief Title:
Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
Psychological Interventions for Parents Caregivers
Parent management techniques- Identification of problem behaviorsdeficit behaviors identification of positive opposites reinforcement techniques
Education on Dysfunctional attitude and their effects and communication techniques conflict management and problem solving strategies
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 by maintaining a structured log book and cutting down on insulin at night etc
Warning signs of Hypoglycemia and its management
Self- Management techniques of Disease Condition Behavioral strategies like goal setting activity scheduling with respect to self-management behaviors
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
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
At the end of 6 months children in both the groups Intervention and Control group will be subjected to a detailed assessment of the Behavior and Cognition and Parental Attitude will be tested for the parents
Eligibility Screening of the child to participate in the study will be based on the Inclusion and Exclusion criteria and willingness to give consent for participation in the study Only screening by Continuous Glucose Monitoring will be done after assessing for eligibility
The eligibility for entry into the RCT will be based on the results of the CGM monitoring for measuring Hypoglycemia UnawarenessThe parents of children with Hypoglycemia Unawareness will be chosen for Psychological Counselling on Dysfunctional attitude
Study procedure
1 st contact - referral screening informed consent and Baseline assessments of age diagnosis of type-1 DM Time duration 30 min
After regular follow-up visit with the treating doctor if the patient fulfill all the inclusion criteria the treating doctor will request the patient to meet the study team
Patient will meet the study team in a private room adjacent to the Hospital Building The junior research fellow JRF briefs the patient about the study and the study information sheet will be given for the detailed understanding of the process
If patient wishes to continue further the JRF will screen the patient for the eligibility by using a Continuous Glucose Monitoring
The screening will be by Continuous Glucose Monitoring wherein a glucose monitor will be affixed to the child for glucose readings for a maximum period of 2 weeks There will also be a verbal process to check eligibility criteria for this study If the patient is not eligible by not having documented Hypoglycemia Unawareness then the participation in this study will end PS Screening procedures for the study eligibility may involve the review and collection of information from patients medical record If the patient has documented Hypoglycemia awareness as is assessed from the reader which is paired to the Glucose sensor
This will be followed by obtaining written informed consent from the patients caregiver if he considers his childs participation in theRandomized Control Trial
After successful entry into the study the patient will be asked about the demographic details including medical treatment history
Baseline assessments to assess Behavior cognitive functions and parental attitude will be done by the Psychologist Time duration 140 minutes
After this patient will be randomly allotted to either the Multi-domain Intervention Group or Treatment as-usual group
Contact details like phone number will be collected to monitor the practices and inform follow-up visits The name and phone number of 1 to 3 people related to patient whom the study team could contact in case of a missed appointment when researchers are unable to reach patient after several attempts or in case of an emergency This person will know that the patient is participating in the study
2 nd and 3rd contacts Multi-domain Intervention after 2 months and 4 months Time duration for re-inforcement of interventions 30 minutes contact
If the participant is in the Treatment as-usual group heshe will be asked to continue coming for check-ups every 3 months
Final assessment After 6 months of intervention to assess Behavior cognitive functions and parental attitude will be done by the Psychologist
After the study period the participants will be appropriately directed towards the future care
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
Psychological Interventions for Parents Caregivers
Parent management techniques- Identification of problem behaviorsdeficit behaviors identification of positive opposites reinforcement techniques
Education on Dysfunctional attitude and their effects and communication techniques conflict management and problem solving strategies
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 by maintaining a structured log book and cutting down on insulin at night etc
Warning signs of Hypoglycemia and its management
Self- Management techniques of Disease Condition Behavioral strategies like goal setting activity scheduling with respect to self-management behaviors
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
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
At the end of 6 months children in both the groups Intervention and Control group will be subjected to a detailed assessment of the Behavior and Cognition and Parental Attitude will be tested for the parents
Eligibility Screening of the child to participate in the study will be based on the Inclusion and Exclusion criteria and willingness to give consent for participation in the study Only screening by Continuous Glucose Monitoring will be done after assessing for eligibility
The eligibility for entry into the RCT will be based on the results of the CGM monitoring for measuring Hypoglycemia UnawarenessThe parents of children with Hypoglycemia Unawareness will be chosen for Psychological Counselling on Dysfunctional attitude
Study procedure
1 st contact - referral screening informed consent and Baseline assessments of age diagnosis of type-1 DM Time duration 30 min
After regular follow-up visit with the treating doctor if the patient fulfill all the inclusion criteria the treating doctor will request the patient to meet the study team
Patient will meet the study team in a private room adjacent to the Hospital Building The junior research fellow JRF briefs the patient about the study and the study information sheet will be given for the detailed understanding of the process
If patient wishes to continue further the JRF will screen the patient for the eligibility by using a Continuous Glucose Monitoring
The screening will be by Continuous Glucose Monitoring wherein a glucose monitor will be affixed to the child for glucose readings for a maximum period of 2 weeks There will also be a verbal process to check eligibility criteria for this study If the patient is not eligible by not having documented Hypoglycemia Unawareness then the participation in this study will end PS Screening procedures for the study eligibility may involve the review and collection of information from patients medical record If the patient has documented Hypoglycemia awareness as is assessed from the reader which is paired to the Glucose sensor
This will be followed by obtaining written informed consent from the patients caregiver if he considers his childs participation in theRandomized Control Trial
After successful entry into the study the patient will be asked about the demographic details including medical treatment history
Baseline assessments to assess Behavior cognitive functions and parental attitude will be done by the Psychologist Time duration 140 minutes
After this patient will be randomly allotted to either the Multi-domain Intervention Group or Treatment as-usual group
Contact details like phone number will be collected to monitor the practices and inform follow-up visits The name and phone number of 1 to 3 people related to patient whom the study team could contact in case of a missed appointment when researchers are unable to reach patient after several attempts or in case of an emergency This person will know that the patient is participating in the study
2 nd and 3rd contacts Multi-domain Intervention after 2 months and 4 months Time duration for re-inforcement of interventions 30 minutes contact
If the participant is in the Treatment as-usual group heshe will be asked to continue coming for check-ups every 3 months
Final assessment After 6 months of intervention to assess Behavior cognitive functions and parental attitude will be done by the Psychologist
After the study period the participants will be appropriately directed towards the future care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009114 | NIH | None | None |