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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a new intervention to help improve outcomes for adolescents with type 1 diabetes by reducing diabetes-specific distress and improving resilience skills.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

A1C

Diabetes Distress

Secondary outcome measures

Adherence

Diabetes-specific Quality of Life

Resilience

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,805 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,356 Previous Clinical Trials

4,314,894 Total Patients Enrolled

Joyce P Yi-Frazier, PhDPrincipal InvestigatorSeattle Children's Research Institute

Media Library

PRISM (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03847194 — N/A

Type 1 Diabetes Research Study Groups: PRISM Intervention Arm, Usual Care

Type 1 Diabetes Clinical Trial 2023: PRISM Highlights & Side Effects. Trial Name: NCT03847194 — N/A

PRISM (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03847194 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age for participants in this trial restricted to those over 30 years of age?

"As per the established conditions of participation, only those aged between 13 and 18 are qualified to join this trial."

Answered by AI

Is recruitment for this experimentation ongoing?

"Based on the data available via clinicaltrials.gov, it appears that this trial is not currently recruiting participants. The study was initially posted in January 2020 and last edited October 2022. Nevertheless, there are more than 1262 other studies actively seeking patients at present."

Answered by AI

Who are the eligible participants for this clinical experiment?

"This clinical trial seeks 180 juvenile diabetics aged between 13 and 18. In addition to meeting the age criteria, potential participants must also be fluent in English, able to comprehend intervention sessions and answer surveys accurately, have had type one diabetes for more than 12 months, and display a heightened emotional distress (PAID-T score of at least 30)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRISM for Adolescents With Type 1 Diabetes

Joyce Yi-Frazier 2020. "PRISM for Adolescents With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03847194.

All > Type 1 Diabetes