Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Malignant Neoplasm; Guardian; Hematologic and Lymphocytic Disorder; Parent

Treatments: Other: Educational Activity; Procedure: Patient Monitoring; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03895918

NCI-2019-01554 (Registry Identifier)

I 77618 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Delayed Group (delayed parental skills)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Patient Monitoring

Other: Educational Activity

Early Group (early parental skills)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Patient Monitoring

Other: Educational Activity

Late Group (late parental skills)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Patient Monitoring

Other: Educational Activity