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Behavioral Intervention
Storybook for Explaining Leukemia to Children
N/A
Recruiting
Led By Erin Shields, MA
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes at each timepoint (30 minutes total over the study).
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using a storybook along with the standard child life intervention can reduce stress in parents of children diagnosed with leukemia. They will compare the stress levels of parents who receive the story
Who is the study for?
This trial is for parents or legal guardians of children aged 6-11 who have been newly diagnosed with leukemia. Participants will be involved in child life interventions and must be willing to complete surveys at three different times: when starting, at discharge, and about 3.5 months later.
What is being tested?
The study is testing the impact of a storybook called 'Who is Luke Eemia?' on reducing parental stress compared to standard child life support alone. It also looks at whether the storybook helps improve understanding of leukemia for both parents and their children.
What are the potential side effects?
There are no direct medical side effects from participating in this trial as it involves educational materials rather than medication or medical procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes at each timepoint (30 minutes total over the study).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes at each timepoint (30 minutes total over the study).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Parental Stress, prior to and following child life intervention
Secondary study objectives
Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline).
Parent perception of the child's stress
Parent's Comfort Explaining Aspects of Leukemia Diagnosis
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (Storybook) GroupExperimental Treatment1 Intervention
Parents in this group will receive the "Who is Luke Eemia?" storybook, and will receive guidance from the child life specialist on how to utilize the storybook with their school-aged child. Parents in this study will complete surveys at three timepoints, these surveys include: (1) Comfort Survey (prior to child life intervention), (2) Discharge Survey and (3) Storybook Assessment survey to review the parent's impression of the storybook intervention tool (about 1 week following the child life intervention), and the (4) Parenting Stress Index -4-Short Form (at baseline, at the time of the discharge survey, and about 3.5 months later).
Group II: ControlActive Control1 Intervention
Parents in this group will receive the standard child life interventional support for explaining the leukemia diagnosis to the school-aged patient/sibling. Parents in this study will complete surveys at three timepoints, these surveys include: (1) Comfort Survey (prior to child life intervention), (2) Discharge Survey (about 1 week following the child life intervention), and the (3) Parenting Stress Index-4-Short Form (at baseline, at the time of the discharge survey, and about 3.5 months later).
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Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
249 Previous Clinical Trials
5,074,534 Total Patients Enrolled
8 Trials studying Leukemia
336 Patients Enrolled for Leukemia
Erin Shields, MAPrincipal InvestigatorChildren's Hospital Los Angeles
Kaitlin BennettPrincipal InvestigatorChildren's Hospital Los Angeles
Mandy FloresPrincipal InvestigatorChildren's Hospital Los Angeles