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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2027-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Behavioral Parenting Skills As A Novel Target for Improving Pediatric Medication Adherence

NCT05587582

Acute Lymphoblastic Leukemia

COMPLETED

Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems

NCT02778022

Child Behavior Disorders

COMPLETED NA

Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care

NCT04110236

Child Behavior Problem Parent-Child Relations

COMPLETED NA

Improving Access to a Primary Care Based Positive Parenting Program

NCT03077321

Program Implementation Child Behavior Problem Positive Parenting

COMPLETED NA

University of Oklahoma Parenting Program Attrition

NCT00153465

Child Abuse

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia, Pediatric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CareMeds Intervention

Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.

Group Type EXPERIMENTAL

CareMeds Intervention

Intervention Type BEHAVIORAL

3 parenting sessions will be offered during weeks 2 through 4 of the study period.

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Usual Care Group

Intervention Type BEHAVIORAL

3 parenting sessions will be offered during weeks 13 through 15 of the study period.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CareMeds Intervention

3 parenting sessions will be offered during weeks 2 through 4 of the study period.

Intervention Type BEHAVIORAL

Usual Care Group

3 parenting sessions will be offered during weeks 13 through 15 of the study period.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No