LeukemiaNCT06360718
Effects of Using a Storybook, to Explain Leukemia to Children Versus the Standard Child Life Intervention, on Parental Stress.
A study testing "Who is Luke Eemia?" Storybook in people with Leukemia, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia
- What is being tested?
- "Who is Luke Eemia?" Storybook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Their school-aged children have developmental or cognitive delays, and/or other chronic illnesses.
- Their school-aged child does not give assent to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Erin Shields, MA
About this study
Official title: Effects of a Storybook About New Leukemia Diagnosis Versus Standard Child Life Intervention on Parental Stress: a Pilot Randomized Controlled Study
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:
Read more
- 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.
Read the 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.
- Conditions
- Leukemia
- Being tested
- "Who is Luke Eemia?" Storybook
- Keywords
- Parental stress, Diagnosis education, Leukemia, Child life, Cancer, Chemotherapy, Hair Loss, School-Age, Intervention, Family-Centered Care
- Medical subject headings
- Leukemia, Neoplasms, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Who is Luke Eemia?" StorybookBehavioural
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 (at the time of discharge, or 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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No 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). |
| Intervention (Storybook) Group | Experimental | 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). Receives: Behavioral: "Who is Luke Eemia?" Storybook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Stress, prior to and following child life intervention
All participating parents/legal guardians will be given the Parenting Stress Index -4 Short Form [PSI™-4-SF] at baseline (before child life intervention), discharge (about 1 week following the child life intervention for extended admissions), and about 3.5 months after the initial survey. The PSI™-4-SF form is a 36-item scale, available in English and Spanish. The form is broken into two domains (child and parent). The questions in the Parent Domain look at identifying sources of stress.
Measured: 10 minutes at each timepoint (30 minutes total over the study).
Secondary outcomes (4)
Parent's Comfort Explaining Aspects of Leukemia Diagnosis
All parents/legal guardians will be given the Comfort Survey to assess parent comfort levels and parent perception of their child's understanding of the leukemia diagnosis prior to receiving the child life intervention. The Comfort Survey is a non-standardized survey, designed by the PI to elicit information about parental comfort explaining the diagnosis at baseline
Measured: at Baseline
Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline).
Parents/legal guardians randomized to the Intervention Group will complete the Storybook Assessment survey. The Storybook Assessment will measure the parent's overall impression of the educational storybook intervention tool.
Measured: Baseline to 1 week
Parent perception of the child's stress
All participating parents/legal guardians will be given the PSI™-4-SF at baseline (before child life intervention), discharge (about 1 week following the child life intervention for extended admissions), and about 3.5 months after the initial survey. The PSI™-4-SF form is a 36-item scale, available in English and Spanish. The form is broken into two domains (child and parent). The Child Domain will explore questions around the parent's perception of the child's stress.
Measured: 10 minutes at each timepoint (30 minutes total over the study).
Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline).
All parents/legal guardians will be given the Discharge Survey to assess the parent's perceived importance, comfort, and readiness around discussing aspects of the diagnosis with their child at the time of discharge (about 1 week following the child life intervention). The Discharge Survey will elicit information about their comfort and readiness to explain the diagnosis following child life intervention.
Measured: Baseline to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start3 Feb 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Shields, Children's Hospital Los Angeles
- Investigators
- Erin Shields, MA, Principal investigator, Children's Hospital Los AngelesKaitlin Bennett, Principal investigator, Children's Hospital Los AngelesMandy Flores, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360718
- Sponsor's protocol ID
- CHLA-23-00170
- Status last verified
- Jul 2025
- First submitted
- 3 Apr 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Storybook About New Leukemia Diagnosis Versus Standard Child Life Intervention on Parental Stress: a Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06360718
- Acronym / sponsor ID
- CHLA-23-00170
- Conditions
- Leukemia
- Keywords
- Parental stress, Diagnosis education, Leukemia, Child life, Cancer, Chemotherapy, Hair Loss, School-Age
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No 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). |
| Intervention (Storybook) Group | Experimental | Behavioral: "Who is Luke Eemia?" StorybookParents 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). |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Their school-aged children have developmental or cognitive delays, and/or other chronic illnesses.
- Their school-aged child does not give assent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Who is Luke Eemia?" StorybookParents 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 (at the time of discharge, or 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). | Behavioural | Intervention (Storybook) Group |
Primary outcome
Parental Stress, prior to and following child life intervention
Time frame: 10 minutes at each timepoint (30 minutes total over the study).
All participating parents/legal guardians will be given the Parenting Stress Index -4 Short Form [PSI™-4-SF] at baseline (before child life intervention), discharge (about 1 week following the child life intervention for extended admissions), and about 3.5 months after the initial survey. The PSI™-4-SF form is a 36-item scale, available in English and Spanish. The form is broken into two domains (child and parent). The questions in the Parent Domain look at identifying sources of stress.
4 secondary outcomes
Parent's Comfort Explaining Aspects of Leukemia Diagnosis
Time frame: at Baseline
Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline).
Time frame: Baseline to 1 week
Parent perception of the child's stress
Time frame: 10 minutes at each timepoint (30 minutes total over the study).
Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline).
Time frame: Baseline to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Shields, MA principal investigator
Children's Hospital Los Angeles
Kaitlin Bennett principal investigator
Children's Hospital Los Angeles
Mandy Flores principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Who is Luke Eemia?" Storybook in people with Leukemia, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Shields, MA (323-361-3630, Eshields@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Stress, prior to and following child life intervention (time frame: 10 minutes at each timepoint (30 minutes total over the study).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.