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Clinical Trials/NCT05587582
NCT05587582
Completed
Not Applicable

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

Roswell Park Cancer Institute1 site in 1 country51 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Lymphoblastic Leukemia
Sponsor
Roswell Park Cancer Institute
Enrollment
51
Locations
1
Primary Endpoint
Length of time it takes to administer medication
Status
Completed
Last Updated
last year

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
January 7, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Length of time it takes to administer medication

Time Frame: Up to 5 months

The association between time to ingestion and the DCIPS coded skills will be analyzed

Dyadic Parent-Child Interaction Coding System (DCIPS) - medication ingestion

Time Frame: Up to 5 months

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.

Study Sites (1)

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