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Completed NCT05445284

Group Education Trial to Improve Transition for Parents of Adolescents With T1D

Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases

Sex: All
Ages: 14 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 34
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Location: Montreal Children's Hospital - McGill University Health Centre (MUHC) Montreal Quebec

Summary

The investigators will study if group education for parents of adolescents with type 1 diabetes (T1D) will improve the transition from adolescence to adulthood. The investigators aim to conduct a pilot randomized controlled trial (RCT) of parent group education sessions to assess the feasibility and refine the intervention to inform a full-scale multicenter RCT. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. The aims for the future full-scale multicenter RCT are to assess the effect of parent group education sessions integrated into pediatric care, compared with usual care on self-management, hemoglobin A1c (HbA1c), adverse outcomes and validated measures during the transition from adolescence to adulthood. The investigators will conduct a parallel group, blinded (outcome assessors, data analysts), superiority pilot RCT of parents and their adolescents with T1D (14-16 years of age) followed at a university teaching hospital-based pediatric diabetes clinic in Montreal. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment.

Eligibility Criteria

Inclusion Criteria: * Parents and their adolescents, ages 14-16 years, with a diagnosis of T1D, of at least 6-months. Parent is defined as mother, father, or primary caregiver. * Receiving diabetes care at a university teaching hospital-based pediatric diabetes clinic in Montreal: Montreal Children's Hospital (MCH) * Participants must be fluent in English or French Exclusion Criteria: * Severe neurocognitive disabilities that may preclude parent's ability to participate in a group session * Parents of adolescents participating in the Group Education Trial to Improve Transition in Type 1 Diabetes (GET-IT-T1D) for adolescents

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05445284). StuddyBuddy aggregates publicly available trial information.