Development and Pilot of a Strengths-Based Behavioral mHealth Intervention to Promote Resilience in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Acceptability of T1Doing Well App (Survey)
研究概览
简要总结
Type 1 diabetes (T1D) management is particularly challenging during adolescence as responsibility for management begins to shift from parents to youth, and positive family teamwork is critical to achieving optimal diabetes outcomes. Existing behavioral family interventions for T1D are beneficial but have limited potential for translation to clinical practice, and universal preventive approaches designed to explicitly promote existing T1D management strengths are needed. Ultimately, the goal of this line of research is to validate brief, convenient, and helpful tools that families of all adolescents with T1D can use to strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.
详细描述
Type 1 diabetes (T1D) is among the most common chronic conditions of childhood and its management is complex and relentless. Adolescents have increased risk for worsening glycemic control, putting them at risk for short- and long-term complications. As responsibility for daily T1D management tasks begins to shift from parents to youth, supportive parent-adolescent teamwork promotes optimal diabetes outcomes. However, adolescents' cognitive development, desire for autonomy, and changing family and social relationships can make adherence to treatment recommendations difficult and strain attempts at parent-adolescent teamwork. This study aims to develop and pilot test a mobile app-based behavioral intervention to facilitate positive, supportive parent-adolescent interactions around T1D management. The proposed study has two parts. First, adolescents with T1D (age 12-17), their parents, and diabetes care providers will be invited to participate in designing a smartphone app that supports parents to recognize, keep track of, and reinforce their adolescents for specific positive T1D-related behaviors, or strengths. Example strengths include asking for help with complicated diabetes tasks, talking to friends about diabetes, and expressing confidence or optimism about T1D management. Intermittently throughout the day, the app will push parents a prompt to report which positive T1D behaviors their adolescent has engaged in. The app will generate weekly summary reports of each adolescent's most frequent strength behaviors, and parents will be reminded via the app to praise their adolescent for those patterns. Second, this intervention will be pilot tested with 82 families; parents will be randomized to an intervention or a control condition. Participants in the intervention condition will use the app for 3-4 months and provide feedback, and control participants will receive usual care and will not use the app. The main goal is to determine how often and in what ways families use the app, whether they like it, and to obtain suggestions for improvement. Trends for impact on important diabetes outcomes, such as quality of parent-adolescent relationships, T1D treatment adherence, and glycemic control will also be evaluated. Data - including questionnaires, adherence data from blood glucose meters, and glycemic control biomarkers from a blood draw - will be collected at baseline and again 3-4 months later. The results of this pilot study will help refine the intervention so that it can be evaluated in a fullscale randomized controlled trial. Ultimately, the goal of this research is to validate brief, convenient, and helpful tools that families of all adolescents with T1D can use to strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes according to American Diabetes Association criteria for at least 6 months
- •Treated for type 1 diabetes at Texas Children's Hospital Diabetes Care Center
- •Parent and adolescent fluency in English
- •Parent has mobile device with data plan
排除标准
- •Serious medical, cognitive, or mental health comorbidity in parent or adolescent that would preclude ability to participate
结局指标
主要结局
Acceptability of T1Doing Well App (Survey)
时间窗: 3-4 months after baseline (follow-up timepoint)
Participants in the intervention arm completed the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE), a measure of the users' perceived usefulness of, satisfaction with, and ease of use of a particular technology. The item scale ranges from the minimum to maximum possible score is 1-7, with a higher score representing a better outcome. Acceptability measured as percentage of participants who selected a score of at least 4 (out of 7) on the item "I am satisfied with it," indicating it was at least somewhat acceptable.
Acceptability - Number of Participants That Felt The Intervention Was Well-Received
时间窗: 3-4 months after baseline (follow-up timepoint)
The number of participants that felt the intervention was well-received was collected for Adolescents and Parents. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral. Positive responses indicate the intervention was well-received.
Feasibility of T1Doing Well App - Engagement With App At Least Twice A Week
时间窗: 3-4 months after enrollment (follow-up timepoint)
Feasibility of the app measured by percentage of participants that engaged with or used the app at least twice a week during the intervention period.
Feasibility of Study Design - Recruitment Rate
时间窗: Immediately following enrollment (baseline timepoint)
Recruitment data measured by percent of recruited families that enrolled in study.
次要结局
- Problem Areas in Diabetes-Teen (PAID-T), Adolescent Self-report(3-4 months after baseline (follow-up timepoint))
- Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency(3-4 months after baseline (follow-up timepoint))
- Glycemic Control - HbA1c(3-4 months after baseline (follow-up timepoint))
- Family Impact - Pediatric Quality of Life Impact Module (Peds QL-FI), Parent-report(3-4 months after baseline (follow-up timepoint))
- Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report(3-4 months after baseline (follow-up timepoint))
- Family Communication - Helping for Health Inventory (HHI), Adolescent-report(3-4 months after baseline (follow-up timepoint))
- Family Communication - Helping for Health Inventory (HHI), Parent-report(3-4 months after baseline (follow-up timepoint))
- Diabetes Family Conflict Scale-Revised (DFCS), Parent-report(3-4 months after baseline (follow-up timepoint))
- Diabetes Family Conflict Scale-Revised (DFCS), Adolescent-report(3-4 months after baseline (follow-up timepoint))
- Problem Areas in Diabetes-Teen (PAID-T), Parent-report(3-4 months after baseline (follow-up timepoint))
- Self-Management - Diabetes Self-Management Profile (DSMP), Adolescent Self-report(3-4 months after baseline (follow-up timepoint))
- Self-Management - Diabetes Self-Management Profile (DSMP), Parent-report(3-4 months after baseline (follow-up timepoint))
- Diabetes Strengths and Resilience Measure (DSTAR), Adolescent Self-report(3-4 months after baseline (follow-up timepoint))
- Adolescent Quality of Life - The MIND-Youth Questionnaire, Adolescent Self-report(3-4 months after baseline (follow-up timepoint))
- Parent-Adolescent Relationship Intervention Process Measure, Adolescent Report(3-4 months after baseline (follow-up timepoint))
研究者
Marisa Hilliard
Assistant Professor of Pediatrics
Baylor College of Medicine