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

NCT06074666 — Not applicable, Recruiting, 100 participants, Roswell Park Cancer Institute

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Registry	NCT06074666
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	100 (Estimated)
Sponsor	Roswell Park Cancer Institute (Other); collaborators: National Cancer Institute (NCI)
Conditions	Acute Lymphoblastic Leukemia, Pediatric
Interventions	CareMeds Intervention, Usual Care Group (Behavioral)
Dates	start 2024-11-07, primary completion 2027-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2023-10-10, last updated 2026-04-23
Locations	1 site in United States

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
CareMeds Intervention	Experimental	Behavioral: CareMeds Intervention	Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.
Usual Care	Active comparator	Behavioral: Usual Care Group	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.

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.

+Outcome measures

Primary outcomes

Feasibility of the CareMeds 3 sessions [up to 3 years]: enrollment rates will be measured by number of consents . Reasons for refusal will also be captured

Secondary outcomes

Behavioral Parenting skills [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)
Oral Chemotherapy adherence [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.

+Eligibility

Sex: All, ages: 3 Years to 9 Years

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

+Locations (1)

Facility	City	Country	Status
Roswell Park Comprehensive Cancer Center	Buffalo, New York	United States	Recruiting

+Investigators

Elizabeth Bouchard, PhD, Principal investigator, Roswell Park Comprehensive Cancer Center

+Funding

NIH grants: R01CA258337