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

NCT06360718 | Recruiting

• 1 other identifier: CHLA-23-00170
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  10 minutes at each timepoint (30 minutes total over the study).

Secondary Outcomes (4)

• Parent's Comfort Explaining Aspects of Leukemia Diagnosis

  at Baseline

• Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline).

  Baseline to 1 week

• Parent perception of the child's stress

  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).

  Baseline to 1 week

Study Arms (2)

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).

Behavioral: "Who is Luke Eemia?" Storybook

Interventions

"Who is Luke Eemia?" Storybook BEHAVIORAL

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).

Intervention (Storybook) Group

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Their school-aged children have developmental or cognitive delays, and/or other chronic illnesses.
• Their school-aged child does not give assent to participate.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Leukemia; Neoplasms; Alopecia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Shields, MA

  Children&#39;s Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Kaitlin Bennett

  Children&#39;s Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Mandy Flores

  Children&#39;s Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Shields, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Child Life Specialist III

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 11, 2024
• Study Start: February 3, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)