N/A
N=172
PRISM for Adolescents With Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03847194 ↗Enrolled (actual)
172
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: A1C — 8.7; 8.6 percentage of glycosylated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Promoting Resilience in Stress Management (PRISM) (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A1C |
8.7; 8.6 | — |
| PRIMARY Diabetes Distress |
36.2; 39.9 | — |
| SECONDARY Resilience |
25.2; 25.7 | — |
| SECONDARY Diabetes-specific Quality of Life |
56.9; 53.5 | — |
| SECONDARY Adherence |
19.9; 17.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- • 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03847194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.