PRISM for Adolescents With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT03847194|
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: Promoting Resilience in Stress Management (PRISM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized controlled trial with 2 groups: PRISM (intervention) arm or standard of care|
|Masking:||None (Open Label)|
|Official Title:||The Promoting Resilience in Stress Management (PRISM) Intervention: a Multisite Randomized Control Trial in Adolescents With Type 1 Diabetes|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||March 2023|
Experimental: PRISM Intervention Arm
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.
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.
No Intervention: Usual Care
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.
- A1C [ Time Frame: 6 months ]hemoglobin A1C
- diabetes distress [ Time Frame: 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.
- Resilience [ Time Frame: 6 months ]Resilience will be measured with the Connor-Davidson Resilience Scale. Higher scores indicate more resilience. Total score ranges from 0-40.
- Diabetes-specific Quality of Life [ Time Frame: 6 months ]Diabetes-specific Quality of life will be measured with the PEDS-QL Diabetes Module. Higher scores indicate higher quality of life. v. 3.2 which assesses two factors of health-related quality of life: diabetes symptoms (15-items) and diabetes management (18-items). The range of scores for each of the sub scales is 0-100.
- adherence [ Time Frame: 6 months ]Adherence will be measured with the Self-Care Inventory-Revised. Higher scores indicate higher adherence. Total score ranges from 5-75.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847194
|Contact: Sam Scott, BAfirstname.lastname@example.org|
|Principal Investigator:||Joyce P Yi-Frazier, PhD||Seattle Children's Research Institute|