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

Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Studies 1 and 2

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

Study Overview

• Status: Completed
• Conditions: Acute Lymphoblastic Leukemia
• Intervention / Treatment: Other: Survey Administration

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (Family Behaviors); 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.

Other: Survey Administration; Complete a survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyadic Parent-Child Interaction Coding System (DCIPS) - medication ingestion	Association between ingestion of medication and the absence or presence of each of the Observations of parents and children as they interact with each other during medication administration. Interactions will be coded by trained observers.	Up to 5 months
Length of time it takes to administer medication	The association between time to ingestion and the DCIPS coded skills will be analyzed	Up to 5 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elizabeth Bouchard, PhD, Roswell Park Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): January 7, 2025
• Study Completion (Actual): January 7, 2025

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: I 1832021; R01CA258337 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No