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

Not Applicable

Recruiting

• Conditions: Acute Lymphoblastic Leukemia, Pediatric
• Interventions: Behavioral: Usual Care Group; Behavioral: CareMeds Intervention

• Registration Number: NCT06074666
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Study Start: 2024-11-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care Group	Usual care consists of medical consultations and supportive care, The usual care group will serve as a delayed intervention/wait list group for which 3 parent training sessions will be offered during weeks 13 through 15.
CareMeds Intervention	CareMeds Intervention	Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.

Primary Outcome Measures

Name	Time	Method
Feasibility of the CareMeds 3 sessions	up to 3 years	enrollment rates will be measured by number of consents . Reasons for refusal will also be captured

Secondary Outcome Measures

Name	Time	Method
Behavioral Parenting skills	Weeks 1, 4 and 12.	Self reported measure to assess the frequency of parental engagement on a scale from 1 (not at all) to 7 (Most of the time)
Oral Chemotherapy adherence	UP to week 12	Will be measured by the number of days with MEMS cap openings to the number of days 6-MP was prescribed.

Trial Locations

Locations (1)

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States