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Recruiting

Effects of Using a Storybook, to Explain Leukemia to Children Versus the Standard Child Life Intervention, on Parental Stress.

NCT06360718 · Children's Hospital Los Angeles
In plain English

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Official title
Effects of a Storybook About New Leukemia Diagnosis Versus Standard Child Life Intervention on Parental Stress: a Pilot Randomized Controlled Study
About this study
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.
Eligibility criteria
Parents are approached and enrolled on the inpatient Hematology Oncology unit at CHLA, during the admission where their child received a new leukemia diagnosis. Inclusion Criteria: * 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 3. Parent/legal guardian is over 18 years of age. Exclusion Criteria: * Their school-aged children have developmental or cognitive delays, and/or other chronic illnesses. * Their school-aged child does not give assent to participate.
Study design
Enrollment target: 140 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2024-02-03
Estimated completion: 2026-07-01
Last updated: 2025-08-03
Interventions
Behavioral: "Who is Luke Eemia?" Storybook
Primary outcomes
  • Parental Stress, prior to and following child life intervention (10 minutes at each timepoint (30 minutes total over the study).)
Sponsor
Children's Hospital Los Angeles · other
Contacts & investigators
ContactErin Shields, MA · contact · Eshields@chla.usc.edu · 323-361-3630
InvestigatorErin Shields, MA · principal_investigator, Children&#39;s Hospital Los Angeles
InvestigatorKaitlin Bennett · principal_investigator, Children&#39;s Hospital Los Angeles
InvestigatorMandy Flores · principal_investigator, Children&#39;s Hospital Los Angeles
All locations (1)
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States