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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587582
• Other study ID #: I 1832021
• Secondary ID: R01CA258337
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: November 30, 2026

Study information

• Verified date: November 2023
• Source: Roswell Park Cancer Institute
• Contact: Elizabeth Bouchard, PhD
• Phone: 716-845-1300
• Email: Elizabeth.Bouchard[@]roswellpark.rog
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Survey Administration
Complete a survey

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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