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

NCT05445284 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-08

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Group education sessions for parents plus usual diabetes care

≥3 in person/virtual group education sessions for parents in addition to usual diabetes care, every 3 months for 12 months

OTHER

Usual diabetes care

Usual diabetes care, every 3-month for 12 months

Sponsors & Collaborators

  • Diabetes Canada

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Meranda Nakhla, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2025-09-30
Completion
2026-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445284 on ClinicalTrials.gov