Clinical trial NCT05587582: Behavioral Parenting Skills As A Novel Target for Improving Pediatric Medication Adherence
Official title: Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Studies 1 and 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-10-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Eligibility 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

Primary outcomes:
measure: Dyadic Parent-Child Interaction Coding System (DCIPS) - medication ingestion
timeFrame: Up to 5 months
measure: Length of time it takes to administer medication
timeFrame: Up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Comprehensive Cancer Center
name: Elizabeth Bouchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: