Clinical trial NCT06360718: Effects of Using a Storybook, to Explain Leukemia to Children Versus the Standard Child Life Intervention, on Parental Stress.
Official title: Effects of a Storybook About New Leukemia Diagnosis Versus Standard Child Life Intervention on Parental Stress: a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia
Keywords: Parental stress
Diagnosis education
Leukemia
Child life
Cancer
Chemotherapy
Hair Loss
School-Age
Intervention
Family-Centered Care
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Parental Stress, prior to and following child life intervention
timeFrame: 10 minutes at each timepoint (30 minutes total over the study).
Secondary outcomes:
measure: Parent's Comfort Explaining Aspects of Leukemia Diagnosis
timeFrame: at Baseline
measure: Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline).
timeFrame: Baseline to 1 week
measure: Parent perception of the child's stress
timeFrame: 10 minutes at each timepoint (30 minutes total over the study).
measure: Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline).
timeFrame: Baseline to 1 week
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children&#39;s Hospital Los Angeles
name: Erin Shields, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Children&#39;s Hospital Los Angeles
name: Kaitlin Bennett
role: PRINCIPAL_INVESTIGATOR
affiliation: Children&#39;s Hospital Los Angeles
name: Mandy Flores
role: PRINCIPAL_INVESTIGATOR
References: