Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360718
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-03
Brief Title:
Effects of Using a Storybook to Explain Leukemia to Children Versus the Standard Child Life Intervention on Parental Stress
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Effects of a Storybook About New Leukemia Diagnosis Versus Standard Child Life Intervention on Parental Stress a Pilot Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 parentlegal guardian stress at three timepoints baseline discharge and follow up
Will this storybook impact parentlegal guardian comfort levels and improve their childs understanding
Participants will be asked to complete surveys at three timepoints prior to and following child life intervention and about 35 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
The main questions it aims to answer are
What effect will the storybook have on parentlegal guardian stress at three timepoints baseline discharge and follow up
Will this storybook impact parentlegal guardian comfort levels and improve their childs understanding
Participants will be asked to complete surveys at three timepoints prior to and following child life intervention and about 35 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 patientsibling 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 ParentChild 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 childs 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 35 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
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 patientsibling 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 ParentChild 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 childs 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 35 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None