Acute Lymphoblastic Leukemia, PediatricNCT06074666
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
A study testing CareMeds Intervention in people with Acute Lymphoblastic Leukemia, Pediatric, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- CareMeds Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Parent is unwilling or unable to follow protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Elizabeth Bouchard, MD, 716-845-8357, elizabeth.Bouchard@roswellpark.org
About this study
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.
Read the 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
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- CareMeds Intervention, Usual Care Group
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareMeds InterventionBehavioural
3 parenting sessions will be offered during weeks 2 through 4 of the study period.
Usual Care GroupBehavioural
3 parenting sessions will be offered during weeks 13 through 15 of the study period.
| Study group | Role | What they receive |
|---|---|---|
| CareMeds Intervention | Experimental | Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4. Receives: 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. Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the CareMeds 3 sessions
enrollment rates will be measured by number of consents . Reasons for refusal will also be captured
Measured: up to 3 years
Secondary outcomes (2)
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)
Measured: 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.
Measured: UP to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start7 Nov 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Bouchard, PhD, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074666
- Sponsor's protocol ID
- I 3774823
- Other IDs
- R01CA258337
- Status last verified
- Apr 2026
- First submitted
- 3 Oct 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
- ClinicalTrials.gov ID
- NCT06074666
- Acronym / sponsor ID
- I 3774823
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CareMeds Intervention | Experimental | Behavioral: CareMeds InterventionParticipants complete the CareMeds parent training sessions during weeks 2, 3 and 4. |
| Usual Care | Active comparator | Behavioral: Usual Care GroupUsual 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. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Parent is unwilling or unable to follow protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareMeds Intervention3 parenting sessions will be offered during weeks 2 through 4 of the study period. | Behavioural | CareMeds Intervention |
| Usual Care Group3 parenting sessions will be offered during weeks 13 through 15 of the study period. | Behavioural | Usual Care |
Primary outcome
Feasibility of the CareMeds 3 sessions
Time frame: up to 3 years
enrollment rates will be measured by number of consents . Reasons for refusal will also be captured
2 secondary outcomes
Behavioral Parenting skills
Time frame: Weeks 1, 4 and 12.
Oral Chemotherapy adherence
Time frame: UP to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Bouchard, PhD principal investigator
Roswell Park Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareMeds Intervention in people with Acute Lymphoblastic Leukemia, Pediatric, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Bouchard, PhD (716-845-1300 ext. 8357, Elizabeth.Bouchard@roswellpark.rog), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the CareMeds 3 sessions (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.