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

NCT05587582 | Completed

• 2 other identifiers: I 1832021R01CA258337
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Survey Administration OTHER

Complete a survey

Observational (Family Behaviors)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elizabeth Bouchard, PhD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 20, 2022
• Study Start: September 1, 2022
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

US (1)