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

NCT05445284 | Active Not Recruiting

• 1 other identifier: 2022-8592
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Transition care; Pediatric; Adolescent; Parent; Education; Self-management; Hemaglobin A1c; Feasibility; Pilot randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• Recruitment feasibility

  Recruitment rate. Proportion of all parents/adolescents approached agreeing to randomization. Feasibility success criteria: at least 50% of approached parents/adolescents agree to participate

  12 months

• Adherence feasibility

  Adherence rate. Proportion of randomized parents attending ≥3 group education sessions. Feasibility success criteria: at least 80% of parents attend at least 3 one-hour group education/support sessions

  12 months

• Response feasibility

  Response rate. Proportion of parents and adolescents completing all validated questionnaires. Feasibility success criteria: at least 80% parents/adolescents complete all questionnaires

  18 months

• Retention feasibility

  Retention rate. Proportion of parents/adolescents completing the 18-month outcome measures. Feasibility success criteria: at least 70% of parents/adolescents complete the trial

  18 months

Secondary Outcomes (12)

• Parent group education session accessibility, acceptance, usefulness

  0, 18 months

• Self-Management

  0, 6, 12, 18 months

• Diabetes Distress - Adolescent

  0, 6, 12, 18 months

• Diabetes Distress - Parent

  0, 6, 12, 18 months

• Family Conflict

  0, 6, 12, 18 months

Study Arms (2)

Group education sessions for parents plus usual diabetes care

EXPERIMENTAL

≥3 in-person/virtual one-hour group education sessions for parents plus usual diabetes care, every 3 months for 12 months and ≥3 "check-in" virtual 15-20 minute sessions in-between the group sessions. Each group session (3-8 parents per group) will be facilitated by a diabetes social worker and will consist of parent-driven discussions on topics relevant to adolescence and transition care. Each one-hour session will commence with an ice-breaker activity and then move to a parent-driven, facilitator-mediated discussion. The group session content will be guided by the needs of the participants; however, the facilitator will actively promote discussion on adolescent- and transition-related topics. The group discussion will end with participants setting goals for their next session.

Behavioral: Group education sessions for parents plus usual diabetes care

Usual diabetes care

OTHER

Usual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual care, individual sessions and meetings related to transition care with the diabetes social worker will be provided to parents, as needed.

Other: Usual diabetes care

Interventions

Group education sessions for parents plus usual diabetes care BEHAVIORAL

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

Group education sessions for parents plus usual diabetes care

Usual diabetes care OTHER

Usual diabetes care, every 3-month for 12 months

Usual diabetes care

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Diabetes Canada: collaborator

Study Sites (1)

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

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (10)

• Ladd JM, Reeves-Latour J, Dasgupta K, Bell LE, Anjachak N, Nakhla M. Toward a better understanding of transition from paediatric to adult care in type 1 diabetes: A qualitative study of adolescents. Diabet Med. 2022 May;39(5):e14781. doi: 10.1111/dme.14781. Epub 2022 Jan 7.

  PMID: 34967058 BACKGROUND

• Alwadiy F, Mok E, Dasgupta K, Rahme E, Frei J, Nakhla M. Association of Self-Efficacy, Transition Readiness and Diabetes Distress With Glycemic Control in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care. Can J Diabetes. 2021 Jul;45(5):490-495. doi: 10.1016/j.jcjd.2021.05.006. Epub 2021 May 19.

  PMID: 34176613 BACKGROUND

• Robinson ME, Simard M, Larocque I, Shah J, Rahme E, Nakhla M. Psychiatric disorders in emerging adults with diabetes transitioning to adult care: A retrospective cohort study. Diabet Med. 2021 Jun;38(6):e14541. doi: 10.1111/dme.14541. Epub 2021 Feb 19.

  PMID: 33576092 BACKGROUND

• Mok E, Henderson M, Dasgupta K, Rahme E, Hajizadeh M, Bell L, Prevost M, Frei J, Nakhla M. Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D). BMJ Open. 2019 Nov 11;9(11):e033806. doi: 10.1136/bmjopen-2019-033806.

  PMID: 31719096 BACKGROUND

• Michaud S, Dasgupta K, Bell L, Yale JF, Anjachak N, Wafa S, Nakhla M. Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Diabet Med. 2018 Jul;35(7):846-854. doi: 10.1111/dme.13627. Epub 2018 May 2.

  PMID: 29577410 BACKGROUND

• Nakhla M, Bell LE, Wafa S, Dasgupta K. Improving the transition from pediatric to adult diabetes care: the pediatric care provider's perspective in Quebec, Canada. BMJ Open Diabetes Res Care. 2017 Jun 30;5(1):e000390. doi: 10.1136/bmjdrc-2017-000390. eCollection 2017.

  PMID: 28761657 BACKGROUND

• Wafa S, Nakhla M. Improving the Transition from Pediatric to Adult Diabetes Healthcare: A Literature Review. Can J Diabetes. 2015 Dec;39(6):520-8. doi: 10.1016/j.jcjd.2015.08.003. Epub 2015 Oct 20.

  PMID: 26498219 BACKGROUND

• Nakhla M, Daneman D, To T, Paradis G, Guttmann A. Transition to adult care for youths with diabetes mellitus: findings from a Universal Health Care System. Pediatrics. 2009 Dec;124(6):e1134-41. doi: 10.1542/peds.2009-0041. Epub 2009 Nov 23.

  PMID: 19933731 BACKGROUND

• Nakhla M, Daneman D, Frank M, Guttmann A. Translating transition: a critical review of the diabetes literature. J Pediatr Endocrinol Metab. 2008 Jun;21(6):507-16.

  PMID: 18717235 BACKGROUND

• Tapp K, Mok E, Davis D, Guerin-Marion S, Frei J, Gibbon M, Henderson M, Miljanovski M, Da Costa D, Shulman R, Nakhla M, Kichler J. Perspectives of parents/caregivers prior to a pilot intervention trial to improve transition to adult care for adolescents with type 1 diabetes: A qualitative study. BMJ Open. 2025 Dec 29;15(12):e108079. doi: 10.1136/bmjopen-2025-108079.

  PMID: 41469044 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Meranda Nakhla, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: Active arm: Participants randomized to the active arm will be asked to attend ≥ 3 group education sessions for parents of adolescents with T1D, in addition to their usual diabetes clinic visits every 3 months, over the 12-month intervention period. Group education sessions will coincide with regularly scheduled clinic visits. Control arm: Participants randomized to usual care will attend their usual 3-month interval diabetes clinic visits, over the 12-month intervention period, which consists of visits with their diabetes care physician.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 6, 2022
• Study Start: October 10, 2023
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)