Skip to main content
OpenTrials
Completed

NCT Number: NCT03895918

Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Guardian Hematologic Diseases Hematologic and Lymphocytic Disorder Hemic and Lymphatic Diseases Malignant Neoplasm Neoplasms Parent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Activity

Other

Undergo parenting skills intervention

Patient Monitoring

Procedure

Undergo medication adherence monitoring

Other names: monitor

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Objective medication adherence

    Time frame: Up to 4 weeks post study

    Assessed using Medication Event Monitoring Systems (MEMS) track caps.The project manager will conduct reviews of each child?s medical record to obtain data on the medication dose prescribed each day and dates when the medication was held for illness or toxicity. MEMS-based adherence variables will be constructed as a percentage based upon the ratio of the number of days with MEMS cap openings (X) to the number of days the medication was prescribed (N). Will remove days when the medication was held by the prescriber from the denominator (X/N x 100).

Secondary outcomes

  1. Change in parenting stress

    Time frame: Baseline up to 4 weeks post study

    Pre and post intervention 15minute surveys

  2. Intervention feasibility

    Time frame: Up to 4 weeks post study

    Assessed using survey assessments

  3. Change in parenting behaviors

    Time frame: Baseline up to 4 weeks

    Pre and Post intervention 15 minute surveys

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2019
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.