Parent Group Education for Adolescent Type 1 Diabetes Transition

(GETIT-Parent Trial)

Overseen By Elise Mok, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Severe neurocognitive disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if group education for parents of teens with type 1 diabetes helps improve the transition to adulthood. The study focuses on parents and aims to teach them how to better support their children in managing their diabetes. The goal is to see if these sessions can make a positive difference in the teens' health and self-management.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Group education sessions for parents in the clinical trial Parent Group Education for Adolescent Type 1 Diabetes Transition?

Research shows that family-centered group education programs can improve diabetes management in adolescents with Type 1 diabetes. Additionally, interventions involving family teamwork and education have been effective in enhancing diabetes care and psychosocial outcomes for both adolescents and their families. ^{1 2 3 4 5}

How does the treatment of parent group education for adolescent Type 1 diabetes transition differ from other treatments?

This treatment is unique because it focuses on educating parents through group sessions to support their adolescents during the transition from pediatric to adult care, which is a critical period for maintaining good diabetes management. Unlike other treatments that may focus solely on the adolescent, this approach involves parents as active participants, potentially improving family dynamics and diabetes outcomes. ^{1 5 6 7 8}

Research Team

Meranda Nakhla, MD

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

I am a parent or primary caregiver of a 14-16 year old with Type 1 Diabetes for at least 6 months.

Receiving diabetes care at a university teaching hospital-based pediatric diabetes clinic in Montreal: Montreal Children's Hospital (MCH)

I am fluent in either English or French.

Exclusion Criteria

I have severe learning or thinking problems that make it hard for me to join group sessions.

Parents of adolescents participating in the Group Education Trial to Improve Transition in Type 1 Diabetes (GET-IT-T1D) for adolescents

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parent group education sessions plus usual diabetes care every 3 months for 12 months

12 months

4 visits (in-person/virtual) every 3 months, plus 3 virtual check-in sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person/virtual) at 6 and 18 months

Treatment Details

Interventions

• Group education sessions for parents
• Usual diabetes care

Trial Overview 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.

Participant Groups

Group I: Usual diabetes care Experimental Treatment 1 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 care Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Diabetes Canada

Collaborator

Trials

13

Recruited

1,200+

Findings from Research

A family-centred group education program for adolescents with Type 1 diabetes did not lead to significant improvements in HbA1c levels compared to conventional care, indicating that the intervention may not be effective in this setting.

Attendance at the education sessions was low, with nearly one-third of families not attending any sessions, suggesting that more personalized and engaging educational approaches may be necessary to better support families managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a diabetes self-management education and family teamwork intervention in adolescents with Type 1 diabetes. Murphy, HR., Wadham, C., Hassler-Hurst, J., et al.[2022]

A 2-year randomized clinical trial involving 390 families showed that a low-intensity, clinic-integrated behavioral intervention significantly improved glycemic control in youth with type 1 diabetes, particularly in those aged 12 to 14.

The intervention effectively prevented the typical decline in diabetes management during adolescence, suggesting it could be a valuable approach to integrate behavioral support into medical care for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Nansel, TR., Iannotti, RJ., Liu, A.[2022]

A systematic review of 80 studies on diabetes education for children with type 1 diabetes found that most educational interventions did not significantly improve metabolic control (HbA1c levels) compared to standard care, indicating limited efficacy.

While some interventions showed positive effects on self-management and psychosocial outcomes, the overall evidence was inconsistent, and no specific educational approach was identified as superior for improving diabetes control or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes education for children with type 1 diabetes mellitus and their families. Couch, R., Jetha, M., Dryden, DM., et al.[2022]

This study evaluates a structured transition program for adolescents with Type 1 diabetes (T1D) to enhance their self-management and empowerment, involving 140 participants aged 16 from two pediatric diabetes clinics.

The effectiveness of this program will be assessed through various outcomes, including patient empowerment and diabetes management, over a period extending to 18.5 years, providing valuable insights into transitional care models for chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol. Brorsson, AL., Bratt, EL., Moons, P., et al.[2021]

Adolescents and young adults with type 1 diabetes face significant health risks during their transition to adult health care, including poor glycemic control and increased emergency department visits, highlighting the need for effective transition strategies.

Qualitative research indicates that these patients benefit from a gradual transition process that includes support from healthcare providers and parents, as well as specific referrals to adult care, suggesting that structured transition models like navigator programs and joint visits can improve engagement in adult-oriented health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 diabetes: addressing the transition from pediatric to adult-oriented health care. Monaghan, M., Baumann, K.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomized trial of a diabetes self-management education and family teamwork intervention in adolescents with Type 1 diabetes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Diabetes education for children with type 1 diabetes mellitus and their families. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Satisfaction With Participation in the First STEPS Behavioral Intervention: Experiences of Parents of Young Children With Newly Diagnosed Type 1 Diabetes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Diabetes in adolescence: effects of multifamily group intervention and parent simulation of diabetes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Components of Interventions That Improve Transitions to Adult Care for Adolescents With Type 1 Diabetes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Type 1 diabetes: addressing the transition from pediatric to adult-oriented health care. [2020]