Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06074666

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Lymphoblastic Leukemia, Pediatric Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Elizabeth Bouchard, MD

CONTACT

[email protected]

716-845-8357

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CareMeds Intervention

Behavioral

3 parenting sessions will be offered during weeks 2 through 4 of the study period.

Usual Care Group

Behavioral

3 parenting sessions will be offered during weeks 13 through 15 of the study period.

Primary outcomes

  1. Feasibility of the CareMeds 3 sessions

    Time frame: up to 3 years

    enrollment rates will be measured by number of consents . Reasons for refusal will also be captured

Secondary outcomes

  1. Behavioral Parenting skills

    Time frame: 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)

  2. Oral Chemotherapy adherence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Bouchard, PhD

CONTACT

[email protected]

716-845-1300 ext. 8357

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.