Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
2 other identifiers
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
November 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
April 23, 2026
April 1, 2026
2.9 years
October 3, 2023
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of the CareMeds 3 sessions
enrollment rates will be measured by number of consents . Reasons for refusal will also be captured
up to 3 years
Secondary Outcomes (2)
Behavioral Parenting skills
Weeks 1, 4 and 12.
Oral Chemotherapy adherence
UP to week 12
Study Arms (2)
CareMeds Intervention
EXPERIMENTALParticipants complete the CareMeds parent training sessions during weeks 2, 3 and 4.
Usual Care
ACTIVE COMPARATORUsual 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.
Interventions
3 parenting sessions will be offered during weeks 2 through 4 of the study period.
3 parenting sessions will be offered during weeks 13 through 15 of the study period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Parent is unwilling or unable to follow protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Bouchard, PhD
Roswell Park Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 10, 2023
Study Start
November 7, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04