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NCT06074666NARecruiting

Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3

Roswell Park Cancer Institute

Start Date

11/7/2024

Completion Date

10/1/2027

Summary

The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.

Detailed Description

This is a pilot randomized controlled trial of the CareMeds program to assess feasibility and obtain preliminary efficacy data among families of young children (ages 3-9) with ALL. The objective of this aim is to implement our study procedures and study conditions (CareMeds vs. usual care control). We hypothesize that pilot findings will support the feasibility of the intervention and suggest important improvements in our behavioral secondary outcomes (i.e., behavioral parenting skills, medication adherence

Eligibility Criteria

Age Range: 3 years to 9 years

Inclusion Criteria: * Parent of a child who is diagnosed and being treated for any type of acute lymphoblastic leukemia (ALL) at a study site. * Parent has primary medication responsibility. * Pediatric patient aged 3-9 years * Child on therapy that includes home-based oral anti-cancer medication, such as 6-MP. * Parent has verbal English or Spanish 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 Exclusion Criteria: * Parent is unwilling or unable to follow protocol requirements

Interventions

BEHAVIORAL

CareMeds Intervention

BEHAVIORAL

Usual Care Group

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Conditions

Acute Lymphoblastic Leukemia, Pediatric

Locations

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14263

United States