Effects of Using a Storybook, to Explain Leukemia to Children Versus the Standard Child Life Intervention, on Parental Stress.
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Children's Hospital Los Angeles
- Study ID
- NCT06360718
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- "Who is Luke Eemia?" Storybook — BEHAVIORALParents 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
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.
Key Dates
- Start date
- Feb 3, 2024
- Status verified
- Jul 2025
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- No Intervention: ControlParents 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) GroupParents 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).
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
- Erin Shields, MA323-361-3630
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Erin Shields, MA |
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