A behavioral intervention to optimize self-management of celiac disease in adolescents

优化青少年乳糜泻自我管理的行为干预

基本信息

批准号：
10488294
负责人：
Shayna Skelley Coburn
金额：
$ 14.54万
依托单位：
CHILDREN'S RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-27 至 2026-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10488294
关键词：
Address Adolescence Adolescent Adult Affect Age Anxiety Applications Grants Attention deficit hyperactivity disorder Autoimmune Diseases Behavior Behavior Therapy Behavioral Bread Butter Caring Celiac Disease Characteristics Child Childhood Chronic Chronic Disease Clinical Cognitive Communities Control Groups Coping Behavior Coping Skills Data Diabetes Mellitus Diet Digestive System Disorders Disease Management Distress Evaluation Family Feedback Focus Groups Food Fright Funding Future Gluten Gluten-free diet Goals Grant Health Hospitals Hour Individual Inflammatory Bowel Diseases Institution Intervention Intervention Trial Interview Intestinal Cancer Knowledge Lead Link Longevity Malignant Neoplasms Measures Medical Research Mental Depression Mental Health Mental disorders Mentored Patient-Oriented Research Career Development Award Mentors Methods Mission Modeling National Institute of Diabetes and Digestive and Kidney Diseases Non-Hodgkin&apos s Lymphoma Obesity Outcome Outcome Measure Parents Participant Peptides Persons Phase Physicians Positioning Attribute Psychosocial Assessment and Care Publishing Quality of life Randomized Randomized Controlled Trials Reporting Research Research Methodology Research Personnel Research Proposals Research Training Risk Science Secure Self Efficacy Self Management Series Social isolation Source Standardization Statistical Data Interpretation Structure Techniques Technology Teenagers Testing Text Text Messaging Training Treatment Efficacy Work Writing Youth base career cost critical developmental period design dietary adherence digital disease diagnosis efficacy trial emotional distress experience follow-up group intervention immunogenic improved innovation intervention refinement mortality mortality risk multidisciplinary nutrition education parent project patient oriented physical conditioning post intervention primary outcome programs psychological symptom psychosocial recruit research data dissemination satisfaction secondary outcome skills social telehealth theories training opportunity

项目摘要

PROJECT SUMMARY/ABSTRACT Celiac disease (CD) is a chronic autoimmune condition whose only currently available treatment is a strict, burdensome gluten-free diet (GFD). The current proposal uses a theory-driven empirical approach for optimizing the GFD for teens and their parents by targeting knowledge, behavior, and coping skills through educational and cognitive behavioral techniques. Integration with telehealth and SMS (short-message service; “text”) technology for delivering the intervention has the potential reduce barriers to specialized treatment at both early and later stages of implementation. This mentored K23 award aligns with NIDDK's mission to “conduct and support medical research and research training and to disseminate science-based information” to conditions such as digestive diseases to improve people's health and quality of life. The proposed training and research plan will provide the necessary experience and training opportunities for the candidate to achieve a long-term career as an independent clinical researcher in optimizing CD treatment for youth and their families. The proposed K23 project and training plan is designed achieve this goal through advanced training in (1) Developing and evaluating patient-centered family interventions in real-world settings; (2) Utilization and statistical analysis of technology for behavioral interventions; (3) Measuring self-management in youth with chronic GI illness; and (4) Enhancing intervention-based grant writing skills and research dissemination. The proposed research and training plan is fully supported by the institution (Children's National Hospital) and will be guided by a multidisciplinary team of two co-mentors and four scientific advisors with expertise in family interventions for pediatric chronic illness (Dr. Streisand, Primary Mentor, Dr. Hinds, Co-Mentor, and Dr. Opipari-Arrigan, Advisor), CD treatment and evaluation of GFD management (Drs. Kerzner and Liu), and advanced research methods (Dr. Bost). The proposed research will refine and test a behavioral intervention for teens with CD and their parents using an iterative stakeholder-centered design. It will consist of refinement of a behavioral intervention for use with teens (ages 12-16) and their parents through a series of focus groups (n=5 dyads), followed by proof of concept testing (n=5 dyads) and a small pilot RCT (n=60 dyads). Proof of concept testing will examine intervention feasibility, acceptability, impact, and lead to further refinements based on feedback. The RCT will examine preliminary efficacy of the intervention and its impact on QOL and GFD management by targeting self-efficacy, illness identity, and food-related activities. The innovative and significant data resulting from this K23 will directly position the candidate to secure future funding as an independent investigator. This research would provide preliminary data to support a large-scale RCT of the intervention, with continued leveraging of technology such as telehealth and text messaging to facilitate access and reach. This work has the potential to make a lasting impact on the standards of care and available treatments to optimize CD management in youth and their families.

项目概要/摘要乳糜泻 (CD) 是一种慢性自身免疫性疾病，目前唯一可用的治疗方法是严格的、当前的提案采用理论驱动的实证方法来进行繁重的无麸质饮食（GFD）。通过针对知识、行为和应对技能，优化青少年及其父母的 GFD 教育和认知行为技术。与远程医疗和 SMS（短信服务）的整合。 “文本”）提供干预的技术有可能减少专业治疗的障碍该指导性 K23 奖项与 NIDDK 的使命相一致。 “开展和支持医学研究和研究培训，并传播基于科学的信息” 改善人们的健康和生活质量的建议培训和消化疾病等条件。研究计划将为候选人提供必要的经验和培训机会，以实现作为一名独立临床研究员，长期从事优化青少年及其家庭 CD 治疗的工作。拟议的 K23 项目和培训计划旨在通过 (1) 的高级培训实现这一目标在现实环境中制定和评估以患者为中心的家庭干预措施（2）利用和行为干预技术的统计分析；（3）衡量青少年的自我管理慢性胃肠道疾病；(4) 加强基于干预的资助写作技巧和研究传播。拟议的研究和培训计划得到了该机构（国家儿童医院）的全力支持，并将由两名共同导师和四名具有家庭专业知识的科学顾问组成的多学科团队指导儿科慢性疾病干预措施（主要导师 Streisand 博士、共同导师 Hinds 博士和 Dr. Hinds） Opipari-Arrigan，顾问），CD 治疗和 GFD 管理评估（Kerzner 博士和 Liu 博士），以及先进的研究方法（博斯特博士）。拟议的研究将完善和测试行为干预。患有 CD 的青少年及其父母使用以利益相关者为中心的迭代设计。通过一系列焦点小组（n=5）对青少年（12-16 岁）及其父母进行行为干预双人），然后是概念验证测试（n=5 双人）和小型试点 RCT（n=60 双人）。测试将检查干预措施的可行性、可接受性、影响，并根据反馈 RCT 将检查干预措施的初步效果及其对 QOL 和 GFD 的影响。通过针对自我效能、疾病认同和食品相关活动进行管理。 K23 产生的重要数据将直接帮助候选人获得未来的资金支持这项研究将为支持大规模随机对照试验提供初步数据。干预，继续利用远程医疗和短信等技术来促进访问这项工作有可能对护理标准和现有服务产生持久影响。优化青少年及其家庭 CD 管理的治疗方法。