What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy and psychological interventions like cognitive-behavioral therapy (CBT). Insulin therapy can cause side effects such as hypoglycemia, weight gain, and injection site reactions. Psychological interventions are generally safe but may lead to temporary emotional discomfort as patients work through distressing thoughts and feelings. These treatments aim to improve both glycemic control and mental well-being, potentially reducing diabetes-specific distress and enhancing quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes, focusing primarily on insulin therapies and adjunctive medications. While the context does not provide specific FDA approvals for person-centered interventions aimed at reducing diabetes distress and improving resilience skills, it does highlight the importance of such interventions in improving quality of life and glycemic control. For instance, the PRISM and STePS trials emphasize the role of behavioral and educational strategies in managing diabetes-specific emotional distress and enhancing resilience among adolescents with Type 1 Diabetes.

What other types of research exist?

Promising alternatives to person-centered interventions for Type 1 Diabetes patients include: 1) Hybrid Closed-Loop (HCL) insulin delivery systems, which have shown modest improvements in glycemic control and high patient satisfaction. 2) Family-centered interventions, which have been effective in improving A1Cs, enhancing family dynamics, and reducing family conflict. 3) The Early Start Denver Model (ESDM), which combines intensive ABA programming with developmental and relationship-based approaches, showing long-term improvements in core ASD symptoms and adaptive behavior, which may be adapted for diabetes care.

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Behavioral Intervention

PRISM for Type 1 Diabetes

N/A

Waitlist Available

Led By Joyce P Yi-Frazier, PhD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

Diagnosed with T1D >12 months

Cognitively able to participate in intervention sessions and complete written surveys.

Must not have

Patient unable to read in the English or Spanish language

Cognitively or physically unable to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program called PRISM to help teens with type 1 diabetes manage stress and improve their blood sugar levels. PRISM includes sessions and a digital app to teach stress management and positive thinking. The goal is to see if these skills can make it easier for teens to control their diabetes and feel better overall. PRISM is a resilience-promoting intervention designed for adolescents and young adults with serious illnesses, including type 1 diabetes.

Who is the study for?

This trial is for English-speaking teens aged 13-18 with type 1 diabetes who've been diagnosed for over a year and are experiencing significant distress. They must be able to participate in sessions and surveys. Those unable or unwilling to participate, wards of the state, or non-English speakers can't join.

What is being tested?

The PRISM program aims to help these adolescents manage stress better, which may lead to improved blood sugar control and quality of life. Participants will be randomly assigned either to receive this new intervention or not as part of the study's comparison.

What are the potential side effects?

Since PRISM is a resilience-training program rather than a medication, it doesn't have typical drug side effects. However, participants might experience emotional discomfort when discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

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

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I was diagnosed with Type 1 Diabetes over a year ago.

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I can understand and participate in sessions and fill out surveys.

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I am between 13 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot read English or Spanish.

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I am able to understand and physically participate in the trial.

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I, or my parents if I'm under 18, agree to participate in the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A1C

Diabetes Distress

Secondary study objectives

Adherence

Diabetes-specific Quality of Life

Resilience

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PRISM Intervention ArmExperimental Treatment1 Intervention

The goal of the intervention is to teach resilience resource skills for use in current or future stressful situations. The total intervention consists of two, 45-60 minute, one-on-one sessions approximately 2-4 weeks apart followed by a family meeting discussing the skills learned. Following the family session through week 12, participants receive bi-weekly "booster" contacts (1:1 check-in sessions with the interventionist) to practice/refresh skills and check-ins on how skills have been utilized. These boosters will then be delivered monthly in months 4-6. In addition, all PRISM participants have access to the digital PRISM app, which offers an interactive practice and tracking interface to continue enhancing skills.

Group II: Usual CareActive Control1 Intervention

Families in both randomization arms will receive usual medical care for diabetes, including psychosocial care provided by the mental health professionals affiliated with the diabetes clinic if needed. At both sites, every diabetes patient is cared for by a team of diabetes specialists which includes a provider (MD, Physician Assistant and/or Nurse Practitioner), dietician, and social worker. Subspecialty referrals for additional mental health or other support are made at the discretion of the primary diabetes provider.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Promoting Resilience in Stress Management (PRISM)

2023

Completed Phase 2

~270

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for Type 1 Diabetes (T1D) is insulin therapy, which involves administering exogenous insulin to compensate for the body's inability to produce insulin. This is essential for regulating blood glucose levels and preventing hyperglycemia and its complications. Additionally, psychological interventions, like the person-centered approach studied in the PRISM trial, aim to reduce diabetes-related distress and improve resilience skills. These interventions are important as they help manage the emotional and psychological challenges of T1D, thereby improving treatment adherence and overall quality of life.

Systematic review and meta-analysis of randomized controlled trials of psychological interventions to improve glycaemic control in children and adults with type 1 diabetes.Assessment of a Precision Medicine Analysis of a Behavioral Counseling Strategy to Improve Adherence to Diabetes Self-management Among Youth: A Post Hoc Analysis of the FLEX Trial.Person-Centered Interactive Self-Management Support in Primary Health Care for People with Type 2 Diabetes: Protocol for a Randomized Controlled Trial.