Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-9
SponsorRoswell Park Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Parent is unwilling or unable to follow protocol requirements
Trial design
Design model
Parallel
Treatments tested in this trial
CareMeds Intervention
Behavioral3 parenting sessions will be offered during weeks 2 through 4 of the study period.
Usual Care Group
Behavioral3 parenting sessions will be offered during weeks 13 through 15 of the study period.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: CareMeds InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
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
Time frame
up to 3 yearsSecondary outcomes
1
Behavioral Parenting skills
Self reported measure to assess the frequency of parental engagement on a scale from 1 (not at all) to 7 (Most of the time)
Time frame
Weeks 1, 4 and 12.2
Oral Chemotherapy adherence
Will be measured by the number of days with MEMS cap openings to the number of days 6-MP was prescribed.
Time frame
UP to week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Roswell Park Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov