Behavioral Parenting Skills As A Novel Target for Improving Pediatric Medication Adherence
18 Years and older, Male and Female
I 1832021 (primary)
NCI-2021-09311
Summary
This study observes behavioral parenting skills to see whether it could be a novel target for improving pediatric medication adherence. This study may help researchers better understand the challenges parents face when giving their young child with an illness medicine at home and learn about various factors related to medication compliance in young children.
Objectives
PRIMARY OBJECTIVES:
I. Use direct observation of medication administration in the home to understand common episode-level barriers and identify the most impactful behavioral parenting skills for intervention.
II. Use daily diary methods to identify contextual barriers to adherence and identify intervention components to help parents anticipate barriers and plan strategies to promote successful adherence.
OUTLINE:
Participants complete a survey over 20 minutes at baseline. Family behaviors before, during and after the administration of medication to the child are self-recorder or research video-recorded over 40-45 minutes. Participants receive medication event monitoring system (MEMS) electronic pill bottle to use for 5 weeks and complete daily survey over 5 minutes for 21 days.
Eligibility
- Parent of a child diagnosed with acute lymphoblastic leukemia (ALL)
- Pediatric patient age: 3 =< age =< 9 years old
- Child on therapy that includes home-based oral anti-cancer medication taken at home, such as mercaptopurine (6-MP)
- Parent age 18 - not applicable (NA) (no limit)
- Parent should have verbal English or Spanish fluency
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- The following special populations may be included in this study:
* Pregnant women: due to the design of this behavioral research, pregnant and fetuses should incur no elevated risk from participation.
* Children under age 18 will participate in one aspect of the study, the video recording of medication administration.
* Other children (not the pediatric patient) under age 18 who are present during the video recorded medication administration session
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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