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

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Treatments: Behavioral: CareMeds Intervention; Behavioral: Usual Care Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06074666

I 3774823

R01CA258337 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CareMeds Intervention

Experimental group

Description:

Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.

Treatment:

Behavioral: CareMeds Intervention

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care Group