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

NCT ID: NCT05445284

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2026-03-31

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.

Detailed Description

Rationale. Adolescence is a challenging life stage that is complicated for those with type 1 diabetes (T1D) as they learn to take responsibility for their health. Parents face uncertainty of what constitutes appropriate involvement and express distress around the health consequences of transferring responsibility to their adolescent. We know little about how to provide transition care services to parents as they attempt to support their adolescents during the transition to adulthood. We are currently conducting a multicenter randomized controlled trial (RCT) evaluating patient-driven group education for adolescents with T1D. Parents have expressed a need for education on how to transition responsibility of diabetes care from parent to adolescent. The investigators propose to study if group education for parents of adolescents with T1D will improve the transition from adolescence to adulthood. The investigators will conduct a pilot RCT of parent group education sessions to assess the feasibility and refine the intervention for a full-scale multicenter RCT.

Aims. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. Through semi-structured interviews with parents, we also aim to identify aspects of the intervention that require refinement for the future full-scale multicenter RCT (e.g. session content and format). To assess feasibility success, we propose the following criteria:1. Recruitment rate: At least 50% of approached parents/adolescents will agree to randomization; 2. Adherence rate: At least 80% of parents attend ≥3 group education sessions; 3. Response rate: At least 80% of parents and adolescents will complete all validated questionnaires; 4. Retention rate: At least 70% of parents and adolescents will complete the trial. The aims for the future full-scale multicenter RCT are to determine the impact of parent group education sessions, compared with usual care on self-management, HbA1c, number of T1D-related emergency department visits and hospitalizations, diabetes distress, family conflict, diabetes resilience and diabetes responsibility.

Methods. 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. Dyads of adolescents and one parent will be recruited over 12 months. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio. Visits in the active arm will consist of a parent group education session plus usual diabetes care every 3 months. The parent group education session, facilitated by a diabetes social worker, will consist of a parent-driven, in-person/virtual discussion on topics relevant to adolescence and transition care. Control arm participants will have usual care with their diabetes care provider every 3 months. Pilot RCT results will inform modification of trial execution related to feasibility and intervention for full-scale multicenter RCT. Main outcome measures are descriptions of study feasibility parameters. Health-related outcomes as well as parent and adolescent reported outcomes, using validated self-administered questionnaires will also be collected at baseline, 6, 12 and 18 months. Parents will be interviewed at baseline and 18 months to explore parents' experiences with and perceptions of the accessibility, acceptance, and usefulness of parent group education content and format, using qualitative descriptive methodology. Analysis will be descriptive and baseline data will be summarized, separately for those in the active and control arms.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group education sessions for parents plus usual diabetes care

≥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.

Group Type: EXPERIMENTAL

Group education sessions for parents plus usual diabetes care

Intervention Type: BEHAVIORAL

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

Usual diabetes care

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.

Group Type: OTHER

Usual diabetes care

Intervention Type: OTHER

Usual diabetes care, every 3-month for 12 months

Interventions

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

Intervention Type: BEHAVIORAL

Usual diabetes care

Usual diabetes care, every 3-month for 12 months

Intervention Type: OTHER

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diabetes Canada

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Meranda Nakhla

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meranda Nakhla, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 34967058 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34176613 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33576092 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31719096 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29577410 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28761657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26498219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19933731 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18717235 (View on PubMed)

Other Identifiers

2022-8592

Identifier Type: -

Identifier Source: org_study_id