Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT06360718
Brief Summary:
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.
Detailed Description:
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:
70 Parent/Child Dyads will be enrolled in this study.
The study team will screen patients upon admission to the inpatient unit, identifying patients newly diagnosed with leukemia. Eligibility criteria requires a patient or sibling to be English or Spanish speaking, and between the ages of 3-16 years of age (without any cognitive or developmental delays or chronic medical conditions). Parent participation requires child assent to enroll.
Enrolled parents will be randomized in the storybook group (intervention), or the standard child life support (control). The school-aged children will be enrolled as research subjects, though all study measures will be completed by parents, including parental impression of their child's understanding.
To assess the effects of the storybook intervention tool, versus the standard child life intervention, parents will complete surveys at three timepoints:
Baseline:
* Parenting Stress Index Short Form (PSI™-4-SF)
* Comfort Survey
Discharge:
* Discharge Survey
* Storybook Assessment (Intervention Group Only)
* The Parenting Stress Index Short Form (PSI™-4-SF)
Follow Up (about 3.5 months after Baseline):
\- The Parenting Stress Index Short Form (PSI™-4-SF)
Summary statistics means, medians, standard deviations and interquartile range will be calculated to summarize variables, we will trend data using graphs, and we will perform pre planned statistical tests in R.
Study:
NCT06360718
Study Brief:
Protocol Section:
NCT06360718