Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients

Study Overview
=================
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.

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

Conditions
-----------------
Guardian, Hematologic and Lymphocytic Disorder, Malignant Neoplasm, Parent

Intervention / Treatment
-----------------
* Other: Educational Activity
* Procedure: Patient Monitoring
* Other: Questionnaire Administration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed Group (delayed parental skills)<br>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. | Other: Educational Activity<br>* Undergo parenting skills intervention<br>Procedure: Patient Monitoring<br>* Undergo medication adherence monitoring<br>* Other names: monitor;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Early Group (early parental skills)<br>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. | Other: Educational Activity<br>* Undergo parenting skills intervention<br>Procedure: Patient Monitoring<br>* Undergo medication adherence monitoring<br>* Other names: monitor;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Late Group (late parental skills)<br>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. | Other: Educational Activity<br>* Undergo parenting skills intervention<br>Procedure: Patient Monitoring<br>* Undergo medication adherence monitoring<br>* Other names: monitor;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective medication adherence | 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). | Up to 4 weeks post study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parenting stress | Pre and post intervention 15minute surveys | Baseline up to 4 weeks post study | 
| Intervention feasibility | Assessed using survey assessments | Up to 4 weeks post study | 
| Change in parenting behaviors | Pre and Post intervention 15 minute surveys | Baseline up to 4 weeks |