Behavioral Parenting Skills as a Novel Target for Improvi... | NCT06074666

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

NCT06074666

Sponsor

Roswell Park Cancer Institute

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Interventions

CareMeds Intervention
Usual Care Group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01CA258337	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2024Actual

Primary Completion Date

Oct 1, 2027Estimated

Completion Date

Oct 1, 2027Estimated

First Submitted Date

Oct 3, 2023

First Submission Date that Met QC Criteria

Oct 3, 2023

First Posted Date

Oct 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 23, 2026Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CareMeds Intervention	Experimental	Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.	Behavioral: CareMeds Intervention
Usual Care	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CareMeds Intervention	Behavioral	3 parenting sessions will be offered during weeks 2 through 4 of the study period.	CareMeds Intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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, 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 is unwilling or unable to follow protocol requirements

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elizabeth Bouchard, PhD	Contact	716-845-1300	8357	Elizabeth.Bouchard@roswellpark.rog

Overall Officials

Name	Affiliation	Role
Elizabeth Bouchard, PhD	Roswell Park Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roswell Park Comprehensive Cancer Center	Recruiting	Buffalo	New York	14263	United States

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided