Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Parent is unwilling or unable to follow the study protocol requirements
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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