Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT06160934
Eligibility Criteria:
Inclusion Criteria:
* Parents/ primary caregivers (aged \>18) of pediatric patients (ages 8-17 years), who have been diagnosed with T1D for at least 3 months, but not greater than 9 months (to ensure the intervention can be delivered within the first year of diagnosis)
* At least one caregiver (\>18) proficient in the English language, as neither the intervention nor scales used in the study have been validated in other languages. The age range of the patient with diabetes 8-17 was chosen to include both middle childhood and adolescence when diagnosis of Type 1 diabetes is most common.
Exclusion Criteria:
* Parents' developmental delay or other cognitive impairment that may interfere with their completion of questionnaires or understanding of psychoeducational concepts, and
* Parental scores in the "severe" range of depression and anxiety, evaluated using routine screening measures for depression and anxiety and which may indicate the parent requires a higher level of care.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06160934
Study Brief:
Protocol Section:
NCT06160934