Who is sponsoring NCT03847194?

NCT03847194 is sponsored by Seattle Children's Hospital.

What drugs are being tested in NCT03847194?

Interventions in NCT03847194: Promoting Resilience in Stress Management (PRISM).

What condition does NCT03847194 study?

NCT03847194 studies Type 1 Diabetes Mellitus.

Is NCT03847194 still recruiting?

NCT03847194 is currently completed. Last updated 6 June 2024.

Are results published for NCT03847194?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-06 · How we verify

NCT03847194

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PRISM for Adolescents With Type 1 Diabetes

Completed NA Results posted Last updated 6 June 2024

What this trial tests

NA trial testing Promoting Resilience in Stress Management (PRISM) in Type 1 Diabetes Mellitus in 172 participants. Completed in 31 March 2024.

Timeline

1 January 2020

Primary endpoint
30 April 2022

31 March 2024

Quick facts

Lead sponsor	Seattle Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	172
Start date	1 January 2020
Primary completion	30 April 2022
Estimated completion	31 March 2024
Sites	2 locations across United States

Drugs / interventions tested

Promoting Resilience in Stress Management (PRISM)

Conditions studied

Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

Seattle Children's Hospital

Who can join

Adults 13 to 18, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

A1C Primary · 6 months

hemoglobin A1C

Group	Value	95% CI
PRISM Intervention Arm	8.7	± 1.8
Usual Care	8.6	± 1.8

Diabetes Distress Primary · 6 months

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.

Group	Value	95% CI
PRISM Intervention Arm	36.2	± 12.5
Usual Care	39.9	± 15.0

Resilience Secondary · 6 months

Resilience will be measured with the Connor-Davidson Resilience Scale. Higher scores indicate more resilience. Total score ranges from 0-40.

Group	Value	95% CI
PRISM Intervention Arm	25.2	± 6.8
Usual Care	25.7	± 7.3

Diabetes-specific Quality of Life Secondary · 6 months

Diabetes-specific Quality of life will be measured using the adolescent self-report version of the Type 1 Diabetes and Life (T1DAL) which assesses diabetes-specific health-related quality of life (HRQOL) for people with type 1 diabetes (T1D). Higher scores indicate higher quality of life. Scale ranges 0-100, with higher scores indicating better quality of life.

Group	Value	95% CI
PRISM Intervention Arm	56.9	± 15.4
Usual Care	53.5	± 15.0

Adherence Secondary · 6 months

Adherence will be measured with the Diabetes Self-Management Questionnaire (DSMQ). The DSMQ ranges from 0-35 with higher scores indicate higher adherence.

Group	Value	95% CI
PRISM Intervention Arm	19.9	± 7.0
Usual Care	17.9	± 9.1

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

From Theory to Patient Care: A Model for the Development, Adaptation, and Testing of Psychosocial Interventions for Patients With Serious Illness.
Rosenberg AR, Steiner J, Lau N, Fladeboe K, et al · · 2021 · cited 16× · PMID 33677072 · DOI 10.1016/j.jpainsymman.2021.02.036
Promoting Resilience in Stress Management for Adolescents With Type 1 Diabetes: A Randomized Clinical Trial.
Yi-Frazier JP, Hilliard ME, O'Donnell MB, Zhou C, et al · · 2024 · cited 10× · PMID 39158914 · DOI 10.1001/jamanetworkopen.2024.28287
"It Just Kind of Feels Like a Different World Now:" Stress and Resilience for Adolescents With Type 1 Diabetes in the Era of COVID-19.
O'Donnell MB, Hilliard ME, Cao VT, Bradford MC, et al · · 2022 · cited 9× · PMID 36992786 · DOI 10.3389/fcdhc.2022.835739
Protocol for the Promoting Resilience in Stress Management (PRISM) intervention: A multi-site randomized controlled trial for adolescents with type 1 diabetes.
O'Donnell MB, Scott SR, Ellisor BM, Cao VT, et al · · 2023 · cited 6× · PMID 36410689 · DOI 10.1016/j.cct.2022.107017
Resilience in adolescent and young adult oncology: Problems and prospects.
Rosenberg AR, Salsman JM. · · 2024 · cited 4× · PMID 38150308 · DOI 10.1002/cncr.35180
"Faith, Family, and Friends": Pandemic-Related Coping in Parents of Adolescents With Type 1 Diabetes.
Baudino MN, Perez SG, O'Donnell MB, Duran B, et al · · 2024 · PMID 40726631 · DOI 10.1037/cpp0000528

Verify or expand the search:

Other trials of Promoting Resilience in Stress Management (PRISM)

Trials testing the same drug.

NCT06051448 — Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mito · Phase 1, PHASE2 · completed
NCT04738474 — Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease · NA · completed
NCT03668223 — The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer · NA · completed

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting

Other Seattle Children's Hospital trials

Trials by the same sponsor.

NCT07522112 — Evaluating a Shared Decision-making Intervention for Families About Firearm Storage · NA · not yet recruiting
NCT06864611 — Evaluating Huddles as a Novel Approach to Improving Concussion Safety · NA · not yet recruiting
NCT07424157 — Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products · not yet recruiting
NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
NCT07097792 — Concussion Recovery and Support Program · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03847194 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seattle Children's Hospital
Last refreshed: 6 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03847194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing