Actively Recruiting

Phase Not Applicable
Age: 3Years - 9Years
All Genders
ID06074666

Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence in Children Aged 3 to 9 with Acute Lymphoblastic Leukemia

Led by Roswell Park Cancer Institute · Updated on 2026-04-23

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Roswell Park Cancer Institute

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the CareMeds program, a behavioral parenting skills intervention, to improve medication adherence among families of young children aged 3 to 9 years diagnosed with pediatric acute lymphoblastic leukemia (ALL). This pilot randomized controlled trial aims to assess the feasibility of the intervention and gather preliminary data on its effects on behavioral parenting skills and medication adherence. The study compares the CareMeds program to usual care to understand its potential benefits in supporting families managing home-based oral anti-cancer medications. Participants are randomly assigned to one of two groups: the CareMeds intervention group or the usual care group. Those in the CareMeds group complete three parent training sessions during weeks 2, 3, and 4 of the study. The usual care group receives standard medical consultations and supportive care, with the same three parent training sessions offered later during weeks 13 through 15 as a delayed intervention. This design allows comparison of outcomes between the two approaches over the study period. During the study, researchers assess feasibility by tracking completion of the CareMeds sessions over up to three years. They also evaluate behavioral parenting skills at weeks 1, 4, and 12, as well as oral chemotherapy adherence up to week 12. Families participate through training sessions and follow-up assessments, with data collection focused on understanding the intervention's impact on medication management and parent behaviors. The total study participation spans several months to allow for thorough evaluation of both intervention feasibility and preliminary effectiveness.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Years - 9Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Parent of a child diagnosed and treated for any type of acute lymphoblastic leukemia (ALL) at a study site
  • Parent has primary responsibility for the child's medications
  • Child aged 3 to 9 years
  • Child is on therapy including home-based oral anti-cancer medication, such as 6-MP
  • Parent is fluent in English or Spanish
  • Parent understands the investigational nature of the study and signs informed consent before participation
Not Eligible

You will not qualify if you...

  • Parent is unwilling or unable to follow the study protocol requirements

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - 15 weeks

Participants in the CareMeds group complete 3 parenting sessions during weeks 2, 3, and 4. The Usual Care group receives standard medical consultations and supportive care, with 3 parenting sessions offered during weeks 13 through 15 as a delayed intervention.

Weekly visits during intervention weeks and follow-up assessments at Weeks 1, 4, and 12

Trial Site Locations

Total: 1 location

1

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14263

Actively Recruiting

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Research Team

E

Elizabeth Bouchard, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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