T1D Parent Check-In for Type 1 Diabetes

Overseen By Alessandra J Caruso, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Developmental delay, Severe depression, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support families during the first year after a child or teen receives a Type 1 diabetes (T1D) diagnosis. It tests a three-session intervention called the T1D Parent Check-in, delivered by diabetes psychologists via telehealth. The researchers aim to determine if this approach boosts parental confidence, reduces family conflict, and improves the child's quality of life. Parents of children aged 8 to 17, diagnosed with T1D for at least three months but less than nine months, might be suitable candidates. Participants will either receive this intervention or continue their usual care, with both groups completing questionnaires over six months.

As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance support for others facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a parenting intervention rather than medication changes.

What prior data suggests that the T1D Parent Check-in intervention is safe for families?

Research has shown that programs like the T1D Parent Check-in help families of children with Type 1 diabetes by building resilience and improving both mental and medical well-being. These programs do not involve medication or medical procedures, which usually reduces the risk of physical side effects.

Past studies, such as the First STEPS program, demonstrated that similar parent-focused programs can boost parents' mood and provide helpful support without causing significant negative effects. This suggests that the T1D Parent Check-in is likely safe and well-received by participants.

Overall, because the program emphasizes mental support and resilience, participants should primarily consider the time and effort required, rather than safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard care for Type 1 Diabetes, which typically focuses on medical management like insulin therapy, the T1D Parent Check-in is unique because it emphasizes psychosocial support for families. This intervention is delivered through structured sessions with a licensed clinical psychologist and includes diabetes-specific materials like handouts and videos tailored for families. Researchers are excited about this approach because it provides a personalized and flexible support system, potentially enhancing family adjustment to Type 1 Diabetes beyond traditional treatments.

What evidence suggests that the T1D Parent Check-in intervention is effective for supporting families with a new Type 1 diabetes diagnosis?

Research shows that the T1D Parent Check-in, which participants in this trial may receive, is designed to strengthen families and improve the health and well-being of children with Type 1 diabetes. Studies emphasize the importance of parents feeling confident in managing their child's diabetes. This confidence, known as parental self-efficacy, is crucial for effectively handling the condition. Programs like the T1D Parent Check-in aim to boost this confidence, potentially leading to better mental and physical health outcomes. Additionally, other programs for parents of children with long-term illnesses have reduced family conflicts and improved quality of life. These findings suggest that the T1D Parent Check-in could benefit families adjusting to a new Type 1 diabetes diagnosis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for parents or primary caregivers over 18 years old of children aged 8-17 who were diagnosed with Type 1 diabetes between 3 to 9 months ago. Participants must be proficient in English as the intervention and study materials are only available in this language.

Inclusion Criteria

You need to have at least one caregiver over 18 who speaks English well because the study materials are only available in English. The study is for children and teenagers between 8 and 17 years old because that's when Type 1 diabetes is usually diagnosed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The T1D Parent Check-in intervention is delivered over three sessions by diabetes psychologists via telehealth.

6 months

3 sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with questionnaires completed at baseline, post-intervention, 1-month follow-up, and 6-month follow-up.

6 months

4 questionnaire completions

Consultation (optional)

Parents in the Treatment As Usual group have the option of a one-time consultation with a psychologist after completing their follow-up questionnaires.

What Are the Treatments Tested in This Trial?

Interventions

• T1D Parent Check-in

Trial Overview The T1D Parent Check-in, a telehealth parenting intervention by diabetes psychologists, is being tested against usual care. It aims to help families adjust after a child's new Type 1 diabetes diagnosis, improve resilience and health outcomes.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The T1D Parent Check-in Group (Intervention Group) will participate in three sessions that will be delivered by a licensed clinical psychologist. In the larger RCT, the intervention will be manualized with training and a treatment protocol that can be delivered by any trained member of the diabetes psychosocial team (e.g., social workers, licensed mental health clinicians, and/or clinical psychologists). The intervention is designed to be both tailored and flexible but with fidelity to a basic structure. Diabetes-specific handouts and videos will be created as part of the intervention and will be provided to families throughout the course of the study.

Group II: Treatment as Usual (TAU) Group Active Control 1 Intervention

Parents assigned to the Treatment As Usual (TAU) group will complete T1-T4 study questionnaires alongside the intervention group. They will also take the Motivation Quiz as part of their T2 questionnaires. Instead of a one-month phone call, these participants will be scheduled for a one-time consultation with a study psychologist after completing their T4 questionnaires. This consultation will entail reviewing the family's specific questionnaire results, discussing challenges/strategies relevant to the family's needs, and providing additional recommendations/referrals as indicated. Families will also be provided access to study resources that will assist with their family's overall adjustment to T1D.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06160934

The T1D Parent Check-In: A Preventative Intervention The goal of this clinical trial is to learn how to best support families during the first year of a child or teen's Type 1 diabetes (T1D) diagnosis.

2. breakthrought1d.org breakthrought1d.org/grants/united-states/massachusetts/the-t1d-parent-check-in-a-preventative-intervention/

The T1D Parent Check-In: A Preventative Intervention The T1D Parent Check-in is intended to promote diabetes-related resilience and positive psychological and medical outcomes among families of children with T1D.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8178719/

Parent Perspectives on Educational and Psychosocial ... Globally, 78,000 youth are diagnosed with type 1 diabetes (T1D) each year (1), but annual rates suggest a 21% increase in diagnoses in the past decade (2).

4. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725009532

Self-efficacy among parents of children and adolescents ... This systematic review highlights the pivotal role of parental self-efficacy in managing type 1 diabetes (T1D) in children and adolescents.

5. jpedres.org jpedres.org/articles/the-efficiency-of-the-triple-p-program-for-parents-of-children-with-type-1-diabetes/jpr.galenos.2020.48991

The Efficiency of the Triple P Program for Parents ... The aim of this study was to investigate the effect of the Triple P-Positive Parenting Training Program, which was applied to the parents of children and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9643142/

First STEPS: Primary Outcomes of a Randomized ... First STEPS improved parents' mood following young children's type 1 diabetes diagnosis. Results indicate likely benefits of parent coach support.

7. ctv.veeva.com ctv.veeva.com/study/the-t1d-parent-check-in-a-preventative-intervention

The T1D Parent Check-In: A Preventative Intervention The goal of this clinical trial is to learn how to best support families during the first year of a child or teen's Type 1 diabetes (T1D) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11430652/

Evaluating a Digitally Delivered, Multi-Modal Intervention ... To our knowledge, Huddle4Parents is the first digital support intervention targeting parents of children with T1D that offers flexible support ...