The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes
NCT ID: NCT02575001
Last Updated: 2020-02-11
Study Results
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Basic Information
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COMPLETED
207 participants
OBSERVATIONAL
2015-07-31
2019-12-31
Brief Summary
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Detailed Description
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The way a person responds to stress is determined by the interplay of genetic and environmental factors. Environmental experiences at specific times of development have been shown to shape individual's hypothalamic-pituitary-adrenal axis (HPA axis) stress response. It is known, that early development of central nervous system is critically dependent on child's interaction with the environment (experience dependent maturation), especially to the attachment to caregivers (most often the mother). Appropriate caregiving is connected to lower basal cortisol levels in children and a more stable HPA axis response after the exposure to stress. Any circumstances that disturbed the formation of the attachment to the primary caregiver (e.g. complications at delivery, psychosocial stressors affecting the mother or mother's postpartum depression) resulted in higher HPA axis responsiveness to stress in the affected children.
Changes in individual genes have also been shown to influence a person's susceptibility to stress and risk for the development of stress-induced psychopathology.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Type 1 diabetes
Children with Type 1 diabetes, age from 8 to 15 years.
The following interventions/exposures will be administered:
Behavioral: Psychological background determinations, Genetic: Genetic susceptibility determination, Procedure/Surgery: Cortisol release test, Procedure/Surgery: Saliva cortisol measurement.
Psychological background determinations
For the psychological background determinations a structured interview and questionnaires will be administered:
1. Child Attachment Interview (CAI)
2. General/sociodemographic questionnaire with the questions on diabetes management, current health status and the child's development in the infancy
3. "Parenting Stress Index" with the "19-item Life Stress Scale" (PSI)
4. Achenbach System of Empirically Based Assessment (CBCL, YSR)
5. Holmes and Rahe "Social readjustment rating scale"
6. Lifetime Incidence of Traumatic Events (LITE) - parent and child reports of child's trauma/loss history (LITE- S/ P)
7. Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS)
Genetic susceptibility determination
DNA will be isolated from the patients' blood samples and form the control subjects buccal swabs. The genes with expected influence to stress reactivity and mental disorders will be tested.
Cortisol release test
Synacthen test - will be used with the group of patients with type 1 diabetes to measure HPA axis reactivity
Saliva cortisol measurement
Saliva cortisol measurement - will be used with the patients before and after the Synacthen test and with the Hashimoto thyroiditis and the healthy control group before and after the Child Attachment Interview
Healthy control
Healthy primary school pupils, age from 8 to 15 years.
The following interventions/exposures will be administered:
Behavioral: Psychological background determinations, Genetic: Genetic susceptibility determination, Procedure/Surgery: Saliva cortisol measurement.
Psychological background determinations
For the psychological background determinations a structured interview and questionnaires will be administered:
1. Child Attachment Interview (CAI)
2. General/sociodemographic questionnaire with the questions on diabetes management, current health status and the child's development in the infancy
3. "Parenting Stress Index" with the "19-item Life Stress Scale" (PSI)
4. Achenbach System of Empirically Based Assessment (CBCL, YSR)
5. Holmes and Rahe "Social readjustment rating scale"
6. Lifetime Incidence of Traumatic Events (LITE) - parent and child reports of child's trauma/loss history (LITE- S/ P)
7. Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS)
Genetic susceptibility determination
DNA will be isolated from the patients' blood samples and form the control subjects buccal swabs. The genes with expected influence to stress reactivity and mental disorders will be tested.
Saliva cortisol measurement
Saliva cortisol measurement - will be used with the patients before and after the Synacthen test and with the Hashimoto thyroiditis and the healthy control group before and after the Child Attachment Interview
Interventions
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Psychological background determinations
For the psychological background determinations a structured interview and questionnaires will be administered:
1. Child Attachment Interview (CAI)
2. General/sociodemographic questionnaire with the questions on diabetes management, current health status and the child's development in the infancy
3. "Parenting Stress Index" with the "19-item Life Stress Scale" (PSI)
4. Achenbach System of Empirically Based Assessment (CBCL, YSR)
5. Holmes and Rahe "Social readjustment rating scale"
6. Lifetime Incidence of Traumatic Events (LITE) - parent and child reports of child's trauma/loss history (LITE- S/ P)
7. Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS)
Genetic susceptibility determination
DNA will be isolated from the patients' blood samples and form the control subjects buccal swabs. The genes with expected influence to stress reactivity and mental disorders will be tested.
Cortisol release test
Synacthen test - will be used with the group of patients with type 1 diabetes to measure HPA axis reactivity
Saliva cortisol measurement
Saliva cortisol measurement - will be used with the patients before and after the Synacthen test and with the Hashimoto thyroiditis and the healthy control group before and after the Child Attachment Interview
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Type 1 DM prior to signature of Patient Informed Consent (PIC) (for the T1D group).
* Age between 8-15 years old (inclusive) at signature of PIC
* Treated by the investigator's centre prior signature of PIC (For the T1D group).
* Willing to undergo all study procedures
Exclusion Criteria
* Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol (e.g. intellectual disability).
8 Years
15 Years
ALL
Yes
Sponsors
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University of Ljubljana, Faculty of Medicine
OTHER
Responsible Party
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Principal Investigators
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Tadej Battelino, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ljubljana, Faculty of Medicine
Locations
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University of Ljubljana, Faculty of Medicine
Ljubljana, , Slovenia
Countries
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References
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Other Identifiers
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Attachment2015
Identifier Type: -
Identifier Source: org_study_id
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