The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes

CompletedOBSERVATIONAL
Enrollment

207

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2019

Conditions
Type 1 DiabetesStress
Interventions
BEHAVIORAL

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

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.

PROCEDURE

Cortisol release test

Synacthen test - will be used with the group of patients with type 1 diabetes to measure HPA axis reactivity

PROCEDURE

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

Trial Locations (1)

1000

University of Ljubljana, Faculty of Medicine, Ljubljana

All Listed Sponsors
lead

University of Ljubljana, Faculty of Medicine

OTHER

NCT02575001 - The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes | Biotech Hunter | Biotech Hunter