Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3

Study Overview
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Brief Summary
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The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.

Detailed Description
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This is a pilot randomized controlled trial of the CareMeds program to assess feasibility and obtain preliminary efficacy data among families of young children (ages 3-9) with ALL. The objective of this aim is to implement our study procedures and study conditions (CareMeds vs. usual care control). We hypothesize that pilot findings will support the feasibility of the intervention and suggest important improvements in our behavioral secondary outcomes (i.e., behavioral parenting skills, medication adherence

Official Title
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Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3

Conditions
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Acute Lymphoblastic Leukemia, Pediatric

Intervention / Treatment
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* Behavioral: CareMeds Intervention
* Behavioral: Usual Care Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent of a child who is diagnosed and being treated for any type of acute lymphoblastic leukemia (ALL) at a study site. Parent has primary medication responsibility. Pediatric patient aged 3-9 years Child on therapy that includes home-based oral anti-cancer medication taken at home, such as 6-MP. Parent has verbal English or Spanish fluency. Participant 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 of a child who is not diagnosed nor being treated for any type of acute lymphoblastic leukemia (ALL) at a study site. Parent does not have primary medication responsibility. Pediatric patient aged 3-9 years Pediatric patient is not on therapy that includes oral anti-cancer medication (e.g., 6-MP). Parent does not have verbal English or Spanish fluency. Parent is unwilling or unable to follow protocol requirements

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: CareMeds Intervention<br>Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4. | Behavioral: CareMeds Intervention<br>* 3 parenting sessions will be offered during weeks 2 through 4 of the study period.<br>|
| Active Comparator: Usual Care<br>Usual care consists of medical consultations and supportive care, The usual care group will serve as a delayed intervention/wait list group for which 3 parent training sessions will be offered during weeks 13 through 15. | Behavioral: Usual Care Group<br>* 3 parenting sessions will be offered during weeks 13 through 15 of the study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the CareMeds 3 sessions | enrollment rates will be measured by number of consents . Reasons for refusal will also be captured | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Parenting skills | Self reported measure to assess the frequency of parental engagement on a scale from 1 (not at all) to 7 (Most of the time) | Weeks 1, 4 and 12. | 
| Oral Chemotherapy adherence | Will be measured by the number of days with MEMS cap openings to the number of days 6-MP was prescribed. | UP to week 12 |