PRISM for Adolescents With Type 1 Diabetes
The Promoting Resilience in Stress Management (PRISM) Intervention: a Multisite Randomized Control Trial in Adolescents With Type 1 Diabetes
2 other identifiers
interventional
172
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedResults Posted
Study results publicly available
September 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedJune 6, 2024
May 1, 2024
2.3 years
February 18, 2019
September 15, 2023
May 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
A1C
hemoglobin A1C
6 months
Diabetes Distress
Diabetes distress will be measured with the Problem Areas in Diabetes Scale, Teen Version. Higher scores indicate more distress. Total score ranges from 6 to 84.
6 months
Secondary Outcomes (3)
Resilience
6 months
Diabetes-specific Quality of Life
6 months
Adherence
6 months
Study Arms (2)
PRISM Intervention Arm
EXPERIMENTALThe 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.
Usual Care
NO INTERVENTIONFamilies 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- They are 13-18 years old
- Diagnosed with T1D \>12 months
- Elevated distress score (PAID-T\>=30)\*\*\*\*\*
- Speak English fluently
- Cognitively able to participate in intervention sessions and complete written surveys.
You may not qualify if:
- Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
- Cognitively or physically unable to participate
- Patient unable to speak in the English language
- Patient unable to read in the English or Spanish language
- Adolescent is ward of state
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98101, United States
Related Publications (2)
Yi-Frazier JP, Hilliard ME, O'Donnell MB, Zhou C, Ellisor BM, Garcia Perez S, Duran B, Rojas Y, Malik FS, DeSalvo DJ, Pihoker C, Bradford MC, Scott S, Devaraj S, Rosenberg AR. Promoting Resilience in Stress Management for Adolescents With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428287. doi: 10.1001/jamanetworkopen.2024.28287.
PMID: 39158914DERIVEDO'Donnell MB, Scott SR, Ellisor BM, Cao VT, Zhou C, Bradford MC, Pihoker C, DeSalvo DJ, Malik FS, Hilliard ME, Rosenberg AR, Yi-Frazier JP. Protocol for the Promoting Resilience in Stress Management (PRISM) intervention: A multi-site randomized controlled trial for adolescents with type 1 diabetes. Contemp Clin Trials. 2023 Jan;124:107017. doi: 10.1016/j.cct.2022.107017. Epub 2022 Nov 21.
PMID: 36410689DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joyce Yi-Frazier
- Organization
- Seattle Children's Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Joyce P Yi-Frazier, PhD
Seattle Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Clinical Research Scientist
Study Record Dates
First Submitted
February 18, 2019
First Posted
February 20, 2019
Study Start
January 1, 2020
Primary Completion
April 30, 2022
Study Completion
March 31, 2024
Last Updated
June 6, 2024
Results First Posted
September 21, 2023
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
The DSMB, Lead RA and study team will regularly assess confidentiality of study participants. The following will be assessed and verified: All data will be maintained on secure computers in locked offices at Seattle Children's Research Institute (data collection center); the participant (and caregiver) has signed informed consent and HIPAA forms; all standard confidentiality/privacy rules and guidelines set by the Seattle Children's Research Institute are in compliance. A Certificate of Confidentiality will be obtained.