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Parent Group Education for Adolescent Type 1 Diabetes Transition (GETIT-Parent Trial)

N/A

Waitlist Available

Led By Meranda Nakhla, MD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be fluent in English or French

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 6, 12, 18 months

Awards & highlights

GETIT-Parent Trial Summary

This trial will study if group education for parents of adolescents with type 1 diabetes will improve the transition from adolescence to adulthood. They will do this by conducting a pilot randomized controlled trial of parent group education sessions to assess the feasibility and refine the intervention.

Who is the study for?

This trial is for parents fluent in English or French, of adolescents aged 14-16 with type 1 diabetes (T1D), who are patients at Montreal Children's Hospital. It excludes those already in the GET-IT-T1D adolescent trial or with severe neurocognitive disabilities.Check my eligibility

What is being tested?

The study tests if group education sessions for parents can help their teens transition into adulthood better than usual diabetes care alone. This pilot randomized controlled trial will lead to a larger study on self-management and health outcomes.See study design

What are the potential side effects?

Since this trial involves educational sessions rather than medical treatments, there are no direct side effects like you'd expect from medication. However, participants may experience stress or emotional discomfort.

GETIT-Parent Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fluent in either English or French.

GETIT-Parent Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 6, 12, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 6, 12, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 6, 12, 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence feasibility

Recruitment feasibility

Response feasibility

+1 more

Secondary outcome measures

Diabetes Distress - Adolescent

Diabetes Distress - Parent

Diabetes Resilience - Adolescent

+9 more

GETIT-Parent Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual diabetes careExperimental Treatment1 Intervention

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 II: Group education sessions for parents plus usual diabetes careExperimental Treatment1 Intervention

≥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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

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

442 Previous Clinical Trials

159,140 Total Patients Enrolled

Diabetes CanadaOTHER

10 Previous Clinical Trials

1,073 Total Patients Enrolled

Meranda Nakhla, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Media Library

Group education sessions for parents Clinical Trial Eligibility Overview. Trial Name: NCT05445284 — N/A

Type 1 Diabetes Clinical Trial 2023: Group education sessions for parents Highlights & Side Effects. Trial Name: NCT05445284 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts for this research project currently underway?

"At present, this medical trial is not actively enrolling patients. As reported on the clinicaltrials.gov website, it was first announced on October 1st 2022 and last updated on July 6th 2021. Despite this, there are still 1449 other trials accepting candidates right now."

Answered by AI

What results are researchers expecting to observe from this experiment?

"The principal objective of this 12 month study is to measure its Response feasibility. Ancillary goals include ascertaining the number of Diabetes-related hospitalizations per person-years (P-Y) at risk via medical records, gauging Parent group education session accessibility, acceptance and usefulness through qualitative interviews with parents, and assessing parental diabetes resilience by way of the Diabetes Specific Self Compassion Scale which scores from 1 to 5."

Answered by AI

To whom is participation in this clinical research open?

"This research trial seeks 34 juveniles aged between 14 and 16 that have metabolic ailments. Eligible candidates must possess a 6-month+ diagnosis of type 1 diabetes, be receiving care from an academic pediatric diabetes clinic in Montreal (Montreal Children's Hospital), plus understand either French or English sufficiently for informed consent purposes. Parents or primary caregivers are also necessary components of this study."

Answered by AI

Recent research and studies

PediatricsJournal

Transition to Adult Care for Youths with Diabetes Mellitus: Findings from a Universal Health Care System

Nakhla, Meranda, Denis Daneman, Teresa To, Gilles Paradis, and Astrid Guttmann. 2009. “Transition to Adult Care for Youths with Diabetes Mellitus: Findings from a Universal Health Care System”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2009-0041.

BMJ Open Diabetes Research & CareJournal

Improving the Transition from Pediatric to Adult Diabetes Care: The Pediatric Care Provider’s Perspective in Quebec, Canada

Nakhla, Meranda, Lorraine E Bell, Sarah Wafa, and Kaberi Dasgupta. 2017. “Improving the Transition from Pediatric to Adult Diabetes Care: The Pediatric Care Provider’s Perspective in Quebec, Canada”. BMJ Open Diabetes Research & Care. BMJ. doi:10.1136/bmjdrc-2017-000390.

Diabetic MedicineJournal

Toward a Better Understanding of Transition from Paediatric to Adult Care in Type 1 Diabetes: A Qualitative Study of Adolescents

Ladd, Jennifer M., Jonathan Reeves‐Latour, Kaberi Dasgupta, Lorraine E Bell, Nadia Anjachak, and Meranda Nakhla. 2022. “Toward a Better Understanding of Transition from Paediatric to Adult Care in Type 1 Diabetes: A Qualitative Study of Adolescents”. Diabetic Medicine. Wiley. doi:10.1111/dme.14781.

Canadian Journal of DiabetesJournal