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

Recruiting
3 - 9 years of age
Both
Phase N/A

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Overview

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.

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

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 taken at home, 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 of a child who is not diagnosed nor being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.
  • Parent does not have primary medication responsibility.
  • Pediatric patient aged 3-9 years
  • Pediatric patient is not on therapy that includes oral anti-cancer medication (e.g., 6-MP).
  • Parent does not have verbal English or Spanish fluency.
  • Parent is unwilling or unable to follow protocol requirements

Study details

Acute Lymphoblastic Leukemia, Pediatric

NCT06074666

Roswell Park Cancer Institute

19 May 2024

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