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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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. Specifically, we are testing a parenting intervention, the T1D Parent Check-in, designed for parents of children, ages 8 to 17 years, who have been newly diagnosed with T1D. This three-session intervention is delivered by diabetes psychologists over telehealth with the goal of helping families adjust to T1D, build resilience, and improve children's long-term health. For this trial, our main question is whether parents like the intervention and find it to be helpful and worth their time and effort. We also want to test whether participating in the intervention helps parents feel more confident in their parenting and problem-solving around diabetes, feel less worried about diabetes, reduce family conflict, and improve children's quality of life. To answer these questions, we will randomly assign study participants to one of two groups; parents will either 1) receive the T1D Parent Check-in intervention, or 2) receive their usual care through clinic. Parents assigned to the second group will have the option of participating in a one-time meeting with the psychologist at the end of the study to receive general information/resources from the study and receive feedback on their questionnaires. Parents in both groups will be asked to complete questionnaires four times over the course of six months. Parents will be paid to complete the questionnaires.

Eligibility Criteria

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

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.

Treatment Details

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.

Participant Groups

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+