A Scalable mHealth Resource to Facilitate Behavioral and Emotional Recovery After Pediatric Traumatic Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in scores of caregiver self-report of psychological distress
研究概览
简要总结
Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Trauma centers in the US have good outcomes for survival and physical recovery, but they typically do not have programs to address the emotional and behavioral needs of families. The purpose of this project is to develop a service that achieves this and that can serve as a good model for trauma centers to use. This project will develop, evaluate, and test CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) to address the behavioral and emotional needs of caregivers and children.
详细描述
This project consists of three main study aims. The first aim is to finalize the CAARE model and research protocol in preparation for the open trial (Aim 2). To complete this study Aim, CAARE will first be refined guided by preliminary work led by the PI with caregivers after pediatric traumatic injury (PTI). Then, we will conduct usability testing and refine the mHealth components of CAARE with about 10 caregivers in preparation for the open trial (Aim 2). Finally, we will debug the research protocol via implementation of the full CAARE intervention with approximately 5 families prior to conducting the open trial. Aim 2, the open trial, is described in more detail in the Arms/Intervention section.
Aim 3 is to assess CAARE implementation feasibility with families, trauma center leaders, and program managers. This will be conducted through qualitative interviews with (1) ~20 caregivers who participated in the open trial - diverse with respect to race, child age, and mental health status - to assess their reactions to CAARE; (2) ~15 pediatric trauma center directors and ~15 pediatric trauma program managers to identify perceived barriers and facilitators associated with implementing CAARE in pediatric trauma centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •caregivers of children who experience pediatric traumatic injury
- •children younger than 12
- •caregivers older than age 18.
排除标准
- •caregiver's primary language is not English
- •self-afflicted injury
- •injuries resulting from caregiver abuse or neglect
研究组 & 干预措施
Families receiving intervention
干预措施: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) (Behavioral)
结局指标
主要结局
Change in scores of caregiver self-report of psychological distress
时间窗: 30 days; 60 days; and 90 days post-baseline
Kessler Psychological Distress Scale (K6); higher scores indicate higher distress levels; Assesses feelings of nervousness, hopelessness, restlessness/fidgetiness, depression, worthlessness, and perceived effort burden; Each question asks patients to indicate how much of the time the child experienced the emotion/behavior during the past week by responding via a 5-point Likert scale (1=All to 5=None)
Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
时间窗: baseline; 30 days; 60 days; and 90 days post-baseline
PROMIS General Life Satisfaction (Caregiver QOL) consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The Pediatric Quality of Life Inventory (PEDSQL) consists of 23 items in that comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Items on the PedsQL are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life.
Change in scores in caregiver proxy-report of child emotional distress, ages 2-11
时间窗: baseline; 30 days; 60 days; and 90 days post-baseline
Pediatric Emotional Distress Scale (PEDS; caregiver proxy report ages 2-11); 21-item parent-report measure was designed to assess and screen for elevated symptomatology in children following exposure to a stressful and/or traumatic event; The measure yields scores on the following scales: 1) Anxious/Withdrawn, 2) Fearful, and 3) Acting Out.
Change in scores in child self-report and caregiver proxy-report of child Posttraumatic Stress
时间窗: baseline; 30 days; 60 days; and 90 days post-baseline
The Child PTSD Symptom Scale, Child and Caregiver Versions (CPSS) includes 26 items assessing PTSD diagnostic criteria and severity in youth ages 6-17. Scores range from 0-51, with higher scores indicating higher symptoms of PTSD
Mean number of child missed daycare/school days due to pediatric traumatic injury
时间窗: 90 days post-baseline
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Change in caregiver health status
时间窗: Baseline, 30 days; 60 days; and 90 days post-baseline
36-item Short Form Health Survey (SF-36) will be used to assess a generic indicator of caregivers' health status assessing physical health, role, social, and mental health function. Higher scores indicate more favorable health state, with scores ranging from 0-100.
Change in scores in child self-report (ages 6-11) of child depression; Caregiver self-report of caregiver depression
时间窗: baseline; 30 days; 60 days; and 90 days post-baseline
Patient Health Questionnaire (PHQ-8) will be used to assess symptoms of caregiver depression, with scores ranging from 0-24 and higher scores indicating higher depression symptoms. The Center for Epidemiological Studies Depression Scale for Children (CESD) is a 20-item measure assessing depression in children ages 6-17. Scores range from 0-60, with higher scores indicating higher symptoms of depression in children
Change in caregiver work and productivity status
时间窗: Baseline, 30 days; 60 days; and 90 days post-baseline
A single questionnaire item asking caregivers whether they are working, laid off/looking for work, not working and not searching for employment, a student, a homemaker, volunteering, caretaking for another, retired, hospitalized or in a skilled nursing facility, in jail, disabled, or homeless.
Mean number of child missed daycare/school days due to pediatric traumatic injury
时间窗: 30 days post-baseline
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Mean number of child missed daycare/school days due to pediatric traumatic injury
时间窗: 60 days post-baseline
Caregiver will report on children's number of school and/or daycare days missed due to the injury
次要结局
未报告次要终点
研究者
Leigh Ridings
Assistant Professor
Medical University of South Carolina