Recruiting

Storybook vs. Standard Intervention

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06360718

Conditions

Leukemia

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

Interventions

"Who is Luke Eemia?" Storybook

Study Details

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.

Conditions

Leukemia

Study ID

NCT06360718

Start date

Feb 3, 2024

Status verified date

Jul, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

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

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

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).

experimental: Intervention (Storybook) Group

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).

Interventions

"Who is Luke Eemia?" Storybook

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).

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). ]

Central Contacts and Locations

Central contacts

Erin Shields, MA

323-361-3630Eshields@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Aug 3, 2025

Last verified

Jul, 2025

Keywords

  • Parental stress
  • Diagnosis education
  • Leukemia
  • Child life
  • Cancer
  • Chemotherapy
  • Hair Loss
  • School-Age
  • Intervention
  • Family-Centered Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2025-08-03.