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RecruitingInterventional

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

NCT ID: NCT06074666Sponsor: Roswell Park Cancer InstituteLast updated: 2026-04-23

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.

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 & interventions

  • BehavioralCareMeds Intervention

    3 parenting sessions will be offered during weeks 2 through 4 of the study period.

  • BehavioralUsual Care Group

    3 parenting sessions will be offered during weeks 13 through 15 of the study period.

Outcome measures

Primary

  • Feasibility of the CareMeds 3 sessions

    enrollment rates will be measured by number of consents . Reasons for refusal will also be captured

    Time frame: up to 3 years

Secondary

  • Behavioral Parenting skills

    Time frame: Weeks 1, 4 and 12.

  • Oral Chemotherapy adherence

    Time frame: UP to week 12

Eligibility criteria

Sex: AllAge: 3 Years to 9 YearsHealthy volunteers: No
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 locations (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

Recruiting
Elizabeth Bouchard, MD · Contact
716-845-8357elizabeth.Bouchard@roswellpark.org
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3 | Cancerify