Effects of a Storybook About New Leukemia Diagnosis Versus Standard Child Life Intervention on Parental Stress: a Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Parental Stress, prior to and following child life intervention
研究概览
简要总结
The goal of this clinical trial is to measure the effects of using a storybook versus standard child life intervention with parents of children newly diagnosed with leukemia on parental stress.
The main questions it aims to answer are:
- What effect will the storybook have on parent/legal guardian stress at three timepoints: baseline, discharge, and follow up?
- Will this storybook impact parent/legal guardian comfort levels and improve their child's understanding?
Participants will be asked to complete surveys at three timepoints, prior to and following child life intervention and about 3.5 months later. During child life interventions, participants will receive resources and support to explain leukemia to their school aged, 3-16-year-old, child (patient or sibling).
Researchers will compare Intervention and Control Groups to see if parental stress is lower in those who received the storybook in addition to the standard child life intervention versus the standard child life intervention alone.
详细描述
Research Design:
This is a pilot randomized controlled study.
Control Group will receive the standard child life care and interventions following a new leukemia diagnosis. This includes meeting one of the primary hematology oncology inpatient certified child life specialists (CCLS) to discuss patient/sibling understanding, language used, family experiences or stressors, and family goals when disclosure information about the diagnosis. Interventions may include books about cancer, personalized learning stories, or interactive activities to explain leukemia, cancer, and chemotherapy.
Intervention Group will receive the standard child life care described in the Control Group above, plus the "Who Is Luke Eemia?" Storybook intervention tool created for this study. This storybook was designed by the PI to offer education on leukemia, cancer, chemotherapy, and hair loss through a child life lens. The CCLS will introduce the storybook and discuss common developmental considerations, offering parents suggestions on how to use it with their child, and answer additional questions.
Study Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent/Legal Guardian of a child a. who is school-aged (3-16 years old) with a new leukemia diagnosis b. with a new leukemia diagnosis who is not school-aged but is a sibling of a school-aged child (<3 years or >16 years old).
- •Parent/legal guardian is able to speak, read, and write English or Spanish, and give informed consent
- •Parent/legal guardian is over 18 years of age.
排除标准
- •Their school-aged children have developmental or cognitive delays, and/or other chronic illnesses.
- •Their school-aged child does not give assent to participate.
结局指标
主要结局
Parental Stress, prior to and following child life intervention
时间窗: 10 minutes at each timepoint (30 minutes total over the study).
All participating parents/legal guardians will be given the Parenting Stress Index -4 Short Form \[PSI™-4-SF\] at baseline (before child life intervention), discharge (about 1 week following the child life intervention for extended admissions), and about 3.5 months after the initial survey. The PSI™-4-SF form is a 36-item scale, available in English and Spanish. The form is broken into two domains (child and parent). The questions in the Parent Domain look at identifying sources of stress.
次要结局
- Parent's Comfort Explaining Aspects of Leukemia Diagnosis(at Baseline)
- Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline).(Baseline to 1 week)
- Parent perception of the child's stress(10 minutes at each timepoint (30 minutes total over the study).)
- Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline).(Baseline to 1 week)
研究者
Erin Shields
Child Life Specialist III
Children's Hospital Los Angeles