Behavioral Parenting Skills As A Novel Target for Improving Pediatric Medication Adherence

Trial Title: Behavioral Parenting Skills As A Novel Target for Improving Pediatric Medication Adherence

NCT ID: NCT05587582

Condition: Acute Lymphoblastic Leukemia

Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Other
Intervention name: Survey Administration
Description: Complete a survey
Arm group label: Observational (Family Behaviors)

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

Detailed description: 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 15-20 minutes at baseline. Family behaviors before, during and after the administration of medication to the child are video-recorded over 40-45 minutes. Participants receive MEMS electronic pill bottle to use for 2 weeks and complete daily survey over 5 minutes for 14 days.

Criteria for eligibility:

Study pop:
Families of young children ages 3-9 diagnosed with acute lymphoblastic leukemia within 4 weeks of oral chemotherapy prescription at Roswell Park Cancer Institute (Buffalo, NY) or Oishei Children's Hospital in Buffalo, New York

Sampling method: Non-Probability Sample
Criteria:
INCLUSION: - Parent of a child diagnosed within the past month with acute lymphoblastic leukemia (ALL) - Pediatric patient's age 3 - 9. * If present during the home visit, any other child, ages 0-18 - Child on therapy that includes oral mercaptopurine (6-MP) administration - Parent age 18 - NA (No Limit) - Parent should have verbal English 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 that are present during the time of the home visit Exclusion: - Pediatric patient is on therapy that does not include oral 6-MP administration - Cognitively impaired adults/adults with impaired decision-making capacity - Pediatric patients who are not yet adults (infants under the age of 3, children over 9 years, teenagers) - Prisoners

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Locations:

Facility:
Name: Roswell Park Cancer Institute

Address:
City: Buffalo
Zip: 14263
Country: United States

Start date: September 1, 2022

Completion date: November 30, 2026

Lead sponsor:
Agency: Roswell Park Cancer Institute
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Roswell Park Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05587582