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

Diabetes Mellitus Clinical Trial

— GETIT-Parent  

Official title:

Group Education Trial to Improve Transition for Parents of Adolescents With Type 1 Diabetes: A Pilot Randomized Controlled, Superiority Trial (GET-IT For Parents)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05445284
• Other study ID #: 2022-8592
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: March 2026

Study information

• Verified date: December 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital - McGill University Health Centre (MUHC)	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Diabetes Canada

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Parent group education session accessibility, acceptance, usefulness	Parent interviews to explore parents' experiences with and perceptions of the accessibility, acceptance, and usefulness of the parent group education content and format, using qualitative descriptive methodology	0, 18 months
Secondary	Self-Management	Self-Care Inventory-Revised Questionnaire assesses parent and adolescent self-management. The scores range from 1 to 5. Items scores are averaged to compute the score. A higher score represents a better outcome.	0, 6, 12, 18 months
Secondary	Diabetes Distress - Adolescent	Problem Areas in Diabetes Scale-Teen (PAID-T) assesses adolescent diabetes distress. The scores range from 14 to 84. A total distress score is computed by summing responses. Higher scores indicate youth perception of feeling more burdened related to T1D.	0, 6, 12, 18 months
Secondary	Diabetes Distress - Parent	Problem Areas in Diabetes Scale-Parent (PAID-P) assesses parent diabetes distress. The scores range from 15 to 90. A total distress score is computed by summing responses. Higher scores indicate higher levels of distress and burden.	0, 6, 12, 18 months
Secondary	Family Conflict	Diabetes Family Conflict Scale assesses parent and adolescent family conflict. Total scores range from 19 to 57. A total score is calculated by summing all the item scores. Higher scores reflect greater family conflict.	0, 6, 12, 18 months
Secondary	Diabetes Resilience - Adolescent	DSTAR-youth assesses adolescent diabetes resilience. Total scores range from 12 to 60. A total score is calculated by summing all the item scores. Higher scores reflect greater diabetes resilience.	0, 6, 12, 18 months
Secondary	Diabetes Resilience - Parent	Diabetes-Specific Self-Compassion Scale assesses parent diabetes resilience. The score ranges from 1 to 5. A total score is calculated by reverse-scoring the 11 negatively-worded items and taking the mean of all items. Higher scores indicate greater diabetes-specific self compassion.	0, 6, 12, 18 months
Secondary	Responsibility (DFRQ)	Diabetes Family Responsibility Questionnaire (DFRQ) assesses parent and adolescent responsibility (tasks in the family that contribute to the adolescent's diabetes management). Responsibilities are reflected in three domains: general health maintenance, regimen tasks, and social presentation. A total mean score across items is calculated. The score ranges from 1 to 3. Higher scores reflect that the adolescent is taking or initiating responsibility almost all the time.	0, 6, 12, 18 months
Secondary	Responsibility (RCBRS)	Readiness to Change the Balance of Responsibility Scale (RCBRS) assesses parent and adolescent responsibility. The score ranges from 1 to 5. A mean score of the 12 items (parent) and the seven items (youth) is calculated. Higher scores represent more readiness to change.	0, 6, 12, 18 months
Secondary	Hemaglobin A1c (HbA1c)	HbA1c is measured at each pediatric diabetes care visit every 3 months as part of the standard of diabetes care and is measured with a capillary blood sample using point of care testing (DCA 2000).HbA1c will be identified from medical record chart.	0, 6, 12, 18 months
Secondary	Diabetes-related hospitalizations	Any diabetes-related hospitalizations in the past 12 months, expressed as number of hospitalizations per person-years (P-Y) at risk will be derived from medical record chart.	0, 12 months
Secondary	Diabetes-related emergency department visits	Any diabetes-related emergency-department visits in the past 12 months, expressed as number of emergency department visits per person-years (P-Y) at risk will be derived from medical record chart	0, 12 months