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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Treatments: Other: Survey Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05587582

I 1832021

R01CA258337 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

51 participants in 1 patient group

Observational (Family Behaviors)

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.

Treatment:

Other: Survey Administration