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临床试验/NCT03847194
NCT03847194已完成不适用

The Promoting Resilience in Stress Management (PRISM) Intervention: a Multisite Randomized Control Trial in Adolescents With Type 1 Diabetes

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
2
主要终点
A1C

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• 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.

排除标准

  • •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

研究组 & 干预措施

PRISM Intervention Arm

Experimental

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.

干预措施: Promoting Resilience in Stress Management (PRISM) (Behavioral)

Usual Care

No Intervention

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.

结局指标

主要结局

A1C

时间窗: 6 months

hemoglobin A1C

Diabetes Distress

时间窗: 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.

次要结局

  • Diabetes-specific Quality of Life(6 months)
  • Adherence(6 months)
  • Resilience(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joyce Yi-Frazier

Senior Clinical Research Scientist

Seattle Children's Hospital

研究点 (2)

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