Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients
NCT ID: NCT03895918
Last Updated: 2021-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2019-01-03
2020-11-25
Brief Summary
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Detailed Description
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I. To pilot test a novel parenting intervention. II. To examine the feasibility and preliminary efficacy of the parenting intervention on child medication adherence among children who are experiencing an illness.
OUTLINE: Participants with poor medication adherence are randomized to 1 of 3 groups.
EARLY GROUP: Participants continue medication adherence monitoring over 1 week and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
DELAYED GROUP: Participants continue medication adherence monitoring over 2 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
LATE GROUP: Participants continue medication adherence monitoring over 3 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Delayed Group (delayed parental skills)
Participants continue medication adherence monitoring over 2 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
Educational Activity
Undergo parenting skills intervention
Patient Monitoring
Undergo medication adherence monitoring
Questionnaire Administration
Ancillary studies
Early Group (early parental skills)
Participants continue medication adherence monitoring over 1 week and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
Educational Activity
Undergo parenting skills intervention
Patient Monitoring
Undergo medication adherence monitoring
Questionnaire Administration
Ancillary studies
Late Group (late parental skills)
Participants continue medication adherence monitoring over 3 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
Educational Activity
Undergo parenting skills intervention
Patient Monitoring
Undergo medication adherence monitoring
Questionnaire Administration
Ancillary studies
Interventions
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Educational Activity
Undergo parenting skills intervention
Patient Monitoring
Undergo medication adherence monitoring
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Parent must have primary medication responsibility
* The child's treatment must include home-based daily oral medication
* Parent must have verbal English fluency
* Participant or legal representative 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 does not have primary medication responsibility
* Child's treatment does not include home-based daily oral medication
* Parent does not have verbal English fluency
* If unable to consent or a prisoner
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study intervention
18 Years
ALL
Yes
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Bouchard
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2019-01554
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 77618
Identifier Type: OTHER
Identifier Source: secondary_id
I 77618
Identifier Type: -
Identifier Source: org_study_id
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