What this study is
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.
What's being tested
- "Who is Luke Eemia?" Storybook
Intervention · 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).
Study details
- Official title
- Effects of a Storybook About New Leukemia Diagnosis Versus Standard Child Life Intervention on Parental Stress: a Pilot Randomized Controlled Study
- Sponsor
- Children's Hospital Los Angeles
- Conditions
- Leukemia
- Enrolling
- 140 people
- Starts
- 2024-02-03
- Est. completion
- 2026-07-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Parents are approached and enrolled on the inpatient Hematology Oncology unit at CHLA, during the admission where their child received a new leukemia diagnosis.
- 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Hospital Los Angeles
Los Angeles, California, United States
- Erin Shields, MA · Contact
Recruiting
Study team
Sponsor
Children's Hospital Los Angeles
Study ID CHLA-23-00170
Principal investigator
Erin Shields, MA
Children's Hospital Los Angeles
Principal investigator
Kaitlin Bennett
Children's Hospital Los Angeles
Principal investigator
Mandy Flores
Children's Hospital Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.