Status:
ACTIVE_NOT_RECRUITING
The T1D Parent Check-In: A Preventative Intervention
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Boston Children's Hospital
Conditions:
Type 1 Diabetes
Diabetes in Children
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn how to best support families during the first year of a child or teen's Type 1 diabetes (T1D) diagnosis. Specifically, we are testing a parenting interventi...
Detailed Description
The purpose of the project is to develop and pilot an innovative, 3-session, Type 1 Diabetes-specific telehealth intervention for parents of newly diagnosed children and adolescents. This study is a m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06160934
Start Date
February 1 2024
End Date
June 1 2026
Last Update
May 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114