Clinical trial NCT03895918: Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients
Official title: A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Guardian
Hematologic and Lymphocytic Disorder
Malignant Neoplasm
Parent
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well a parenting skills intervention works in improving medication adherence in pediatric cancer patients. The parenting skills intervention provides support and skills training to parents who administer medicine daily to their child and may improve the childs taking of medications correctly as prescribed by the doctor. Ultimately, this may improve treatment outcomes, among children who are experiencing an illness.

Detailed description: PRIMARY OBJECTIVES:

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.

Eligibility criteria: Inclusion Criteria:

* Be a parent of a child (2 to 10 years old) with any hematology or oncology diagnosis who is receiving treatment at Roswell Park Comprehensive Cancer Center. We define parents as biological parents, adoptive parents, foster parents, stepparents, and legal guardians
* 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:

* Be a parent of a pediatric patient with any hematology or oncology diagnosis who is receiving treatment at Roswell Park and is \< 2 or \> 10 years old
* 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

Primary outcomes:
measure: Objective medication adherence
timeFrame: Up to 4 weeks post study
Secondary outcomes:
measure: Change in parenting stress
timeFrame: Baseline up to 4 weeks post study
measure: Intervention feasibility
timeFrame: Up to 4 weeks post study
measure: Change in parenting behaviors
timeFrame: Baseline up to 4 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Elizabeth Bouchard
role: PRINCIPAL_INVESTIGATOR
References: