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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
Sponsor:
Information provided by (Responsible Party):
Joyce Yi-Frazier, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Promoting Resilience in Stress Management (PRISM) Not Applicable

Detailed Description:
Adolescents with type 1 diabetes (T1D) are at high risk for elevated diabetes distress, which greatly impacts their adherence, glycemic control (A1C), and overall quality of life (QOL). A potential barrier to improving these experiences may be that adolescents have few opportunities to develop the personal resources needed to handle adversity and manage stress. The "Promoting Resilience in Stress Management" (PRISM) intervention is a manualized, brief, skills-based intervention delivered in 2, 45-60 minute one-on-one sessions, followed by a family meeting and supplemented by booster sessions and a digital app. PRISM was developed from Stress and Coping theory and targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making. All of these skills are associated with improved patient outcomes in diverse groups of adolescent populations with chronic/serious illness, and findings from a feasibility trial in adolescents with T1D showed PRISM to be highly feasible and desirable in this population. Further, a recent pilot randomized controlled trial among adolescents with cancer suggest PRISM is associated with improved perceptions of resilience, lower psychological distress, and higher QOL. This application proposes to build on our prior experience and fill three critical knowledge gaps: (1) PRISM's impact on A1C among adolescents with T1D; and (2) PRISM's impact on diabetes distress, self-reported adherence, and other patient-reported outcomes including resilience and QOL. This funding opportunity seeks to test interventions targeting diabetes distress for impact on glycemic control. Thus, the investigators propose a multi-site randomized controlled trial among N=160 adolescents (n=80 PRISM, n=80 Usual Care; ages 13-18) with the primary trial outcome of glycemic control 6-months post-enrollment. Time-in-range will be evaluated for participants on continuous glucose monitors as an exploratory aim. Secondary outcomes will include diabetes-distress, and patient-reported adherence, resilience, and quality of life. The investigators hypothesize PRISM will promote better glycemic control and improved diabetes distress than usual care. This application offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based interventions for adolescents with T1D. Ultimately, this research has the potential to offer a practical, skills-based curriculum designed to improve outcomes for this high-risk group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial with 2 groups: PRISM (intervention) arm or standard of care
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. A1C [ Time Frame: 6 months ]
    hemoglobin A1C

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • They are 13-18 years old

    • Diagnosed with T1D >12 months
    • Most recent A1C >=8.0%
    • Elevated distress score (PAID-T>=44)*****
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847194


Contacts
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Contact: Sam Scott, BA 206-884-1456 samantha.scott@seattlechildrens.org

Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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Principal Investigator: Joyce P Yi-Frazier, PhD Seattle Children's Research Institute

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Responsible Party: Joyce Yi-Frazier, Senior Clinical Research Scientist, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03847194     History of Changes
Other Study ID Numbers: SC-N130
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases