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

Study acronym: GETIT-Parent
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre to McGill University Health Centre/Research Institute of the McGill University Health Centre Show 6 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Sep 2025 to Dec 16, 2025
    • Secondary endpoints: details revised at 9 of 12 entries
    • Site details revised
    • Publications: details revised at 9 of 10 entries
    • Eligibility criteria expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jun 2025 to Sep 2025
    • Study completion date: Dec 2025 to Mar 2026
    • Start date changed from estimate of Jul 2023 to Oct 10, 2023
    • Site details revised
  5. Primary completion date: Oct 2024 to Jun 2025
    • Start date: Oct 2022 to Jul 2023
    • Study completion date: Dec 2024 to Dec 2025
    v3
  6. Collaborator revisedv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05445284
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Diabetes Canada
Conditions
(from sponsor)		 Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
Related terms Autoimmune Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 1, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases, Metabolic Diseases
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov