Behavioral Parenting Skills As A Novel Target for Improving Pediatric Medication Adherence
NCT ID: NCT05587582
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
51 participants
OBSERVATIONAL
2022-09-01
2025-01-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
NCT06074666
The Impact of Parent Training on the Child's Health Services
NCT03704974
Integrating Behavioral Treatment in Primary Care
NCT03658122
Parent Program to Improve Child Behavior Problems
NCT02049749
University of Oklahoma Parenting Program Attrition
NCT00153465
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
FAMILY_BASED
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Survey Administration
Complete a survey
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Survey Administration
Complete a survey
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Bouchard, PhD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I 1832021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.