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PRISM for Adolescents With Type 1 Diabetes

NCT03847194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-06-06

Study results available
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Summary

It is well-known that adolescents with type 1 diabetes are at high risk for elevated diabetes-specific distress and poor glycemic control. This randomized controlled trial uses a novel, person-centered intervention designed to reduce diabetes distress and improve resilience skills, which the investigators hypothesize will in turn improve glycemic control and quality of life. If successful, results will greatly inform future research and clinical strategies aimed at improving outcomes among adolescents with type 1 diabetes.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BEHAVIORAL

Promoting Resilience in Stress Management (PRISM)

PRISM was developed based on stress and coping theory to be a brief, disease non-specific, skills-based intervention targeting adolescent resilience resources. PRISM teaches 4 pillars of resilience including stress management, goal setting, cognitive restructuring and benefit-finding in a one-on-one training program consisting of two, 45-60 minute sessions and supported by 6-months of booster sessions and a fully developed digital app for practice and tracking. A family session follows the individual sessions and was designed for the adolescent to communicate to his/her caregiver(s) the skills learned, and how the caregiver(s) could best support ongoing practice.

Sponsors & Collaborators

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

    collaborator NIH

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Joyce P Yi-Frazier, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-04-30
Completion
2024-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847194 on ClinicalTrials.gov