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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether group education for parents can help adolescents with type 1 diabetes (T1D) transition more smoothly into adulthood. Researchers aim to determine if these sessions, combined with regular diabetes care, ease teens' management of their condition. Parents will join group discussions led by a diabetes social worker to share experiences and strategies. The trial targets parents whose teens (ages 14-16) have had T1D for at least six months and receive care at a specific Montreal hospital. As an unphased trial, this study offers families a unique opportunity to contribute to research that could enhance diabetes management for teens.

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 prior data suggests that group education sessions for parents are safe?

Research has shown that group education sessions for parents of teens with type 1 diabetes are generally safe. Past studies reported no major negative effects from these educational programs. These sessions help parents and their teens manage diabetes as they transition from child to adult care. The focus is on improving self-care and reducing stress, both crucial during this time. While this trial aims to enhance the program, existing evidence suggests that the sessions are well-received and helpful for both parents and teens. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a new way to support parents of adolescents with Type 1 Diabetes during the transition to adulthood. Unlike the typical approach that focuses solely on individual medical care, this method adds group education sessions for parents. These sessions, led by a diabetes social worker, encourage parent-driven discussions on adolescent and transition care topics, making it a more personalized and supportive experience. This approach aims to empower parents with shared insights and strategies, potentially leading to better management of their child's condition during this critical phase.

What evidence suggests that group education sessions for parents could be effective for improving the transition for adolescents with type 1 diabetes?

Research has shown that group education sessions benefit teenagers with type 1 diabetes (T1D) and their families. In this trial, one group of participants will receive group education sessions for parents alongside usual diabetes care. These sessions improve skills needed to manage diabetes and prepare for the transition from child to adult healthcare. For instance, studies have found that such programs can lead to better blood sugar control, as evidenced by improved hemoglobin A1c (HbA1c) levels. Additionally, these programs often boost confidence in managing diabetes, which is crucial for long-term health. Overall, group education for parents aims to support better health outcomes for teenagers with T1D. ^{1 3 6 7 8}

Who Is on the Research Team?

Meranda Nakhla, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6859409/

Group education for adolescents with type 1 diabetes during ... The primary aim of our study is to determine if group education visits for adolescents with T1D, integrated into paediatric care is superior to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000742

Study protocol for the SHIFT randomized clinical trial We present the design of Supporting Health Improvement for Transition in T1D (SHIFT), a randomized clinical trial of a clinic-based transition preparation ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03994536

Effectiveness of a Transition Program for Adolescents With ... The purpose of this study is to assess the effectiveness of a transition program for adolescents with type 1 diabetes within a randomized controlled trial.

4. researchgate.net researchgate.net/publication/337187399_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

Group education for adolescents with type 1 diabetes ... The primary outcome is HbA1c at 18 months. Secondary outcomes include self-efficacy for diabetes self-management, transition readiness, diabetes ...

5. diabetes.jmir.org diabetes.jmir.org/2018/4/e10909/

Transition Education for Young Adults With Type 1 Diabetes The purpose of this pilot study was to test the feasibility, acceptability, and preliminary efficacy of a telehealth transition education ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12306374/

Experiences of adolescents with type 1 diabetes ... To systematically evaluate qualitative studies on the transition from paediatric to adult care during adolescence among patients with type 1 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04073914?term=type1&viewType=Table&rank=1&checkSpell=

A Tool for Parents of Adolescents With Type 1 Diabetes The investigators will determine the effect of the program on parent psychosocial outcomes (stress, depression, and anxiety), adolescent autonomy, parent- ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/edn.96

Experiences with a group intervention for adolescents ... This article aims to describe how group intervention may be useful in the treatment of adolescents with type 1 diabetes. When these children ...