Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CareMeds Intervention, Usual Care Group.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Pediatric. Basic parameters: 3 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Behavioral CareMeds Intervention
3 parenting sessions will be offered during weeks 2 through 4 of the study period. - Behavioral Usual Care Group
3 parenting sessions will be offered during weeks 13 through 15 of the study period.
Primary outcome measures
- Feasibility of the CareMeds 3 sessions [Time frame: up to 3 years]
Secondary outcome measures (2)
- Behavioral Parenting skills [Time frame: Weeks 1, 4 and 12.]
- Oral Chemotherapy adherence [Time frame: UP to week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Roswell Park Comprehensive Cancer Center — Buffalo
Identifiers
NCT: NCT06074666 · I 3774823 · R01CA258337