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

April 22, 2026 updated by: Roswell Park Cancer Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CareMeds Intervention
Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.
Behavioral: CareMeds Intervention
3 parenting sessions will be offered during weeks 2 through 4 of the study period.
Active Comparator: Usual Care
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.
Behavioral: Usual Care Group
3 parenting sessions will be offered during weeks 13 through 15 of the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Weeks 1, 4 and 12.
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.
UP to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Elizabeth Bouchard, PhD, Roswell Park Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 3774823
  • R01CA258337 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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