Acute Lymphoblastic LeukemiaNCT05587582
Behavioral Parenting Skills As A Novel Target for Improving Pediatric Medication Adherence
An observational study of Acute Lymphoblastic Leukemia, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This study observes behavioral parenting skills to see whether it could be a novel target for improving pediatric medication adherence. This study may help researchers better understand the challenges parents face when giving their young child with an illness medicine at home and learn about various factors related to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Survey Administration
- Type of treatment
- Pill or oral medicine
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 7 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Families of young children ages 3-9 diagnosed with acute lymphoblastic leukemia within 4 weeks of oral chemotherapy prescription at Roswell Park Cancer Institute (Buffalo, NY) or Oishei Children's Hospital in Buffalo, New York
Who may be able to join
- Parent of a child diagnosed within the past month with acute lymphoblastic leukemia (ALL)
- Pediatric patient's age 3 - 9.
- If present during the home visit, any other child, ages 0-18
- Child on therapy that includes oral mercaptopurine (6-MP) administration
- Parent age 18 - NA (No Limit)
- Parent should have verbal English fluency
Show all 11Show fewer
- 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
- The following special populations may be included in this study:
- Pregnant women: due to the design of this behavioral research, pregnant and fetuses should incur no elevated risk from participation.
- Children under age 18 will participate in one aspect of the study, the video recording of medication administration.
- Other children (not the pediatric patient) under age 18 that are present during the time of the home visit
Who cannot join
- Pediatric patient is on therapy that does not include oral 6-MP administration
- Cognitively impaired adults/adults with impaired decision-making capacity
- Pediatric patients who are not yet adults (infants under the age of 3, children over 9 years, teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Studies 1 and 2
This study observes behavioral parenting skills to see whether it could be a novel target for improving pediatric medication adherence. This study may help researchers better understand the challenges parents face when giving their young child with an illness medicine at home and learn about various factors related to medication compliance in young children
Read the detailed description
PRIMARY OBJECTIVES:
- Use direct observation of medication administration in the home to understand common episode-level barriers and identify the most impactful behavioral parenting skills for intervention.
II. Use daily diary methods to identify contextual barriers to adherence and identify intervention components to help parents anticipate barriers and plan strategies to promote successful adherence.
OUTLINE:
Participants complete a survey over 15-20 minutes at baseline. Family behaviors before, during and after the administration of medication to the child are video-recorded over 40-45 minutes. Participants receive MEMS electronic pill bottle to use for 2 weeks and complete daily survey over 5 minutes for 14 days.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Survey Administration
- 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.
Survey AdministrationOther
Complete a survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (Family Behaviors) | PRIMARY OBJECTIVES:
I. Use direct observation of medication administration in the home to understand common episode-level barriers and identify the most impactful behavioral parenting skills for intervention.
II. Use daily diary methods to identify contextual barriers to adherence and identify intervention components to help parents anticipate barriers and plan strategies to promote successful adherence.
OUTLINE:
Participants complete a survey over 15-20 minutes at baseline. Family behaviors before, during and after the administration of medication to the child are video-recorded over 40-45 minutes. Participants receive MEMS electronic pill bottle to use for 2 weeks and complete daily survey over 5 minutes for 14 days. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyadic Parent-Child Interaction Coding System (DCIPS) - medication ingestion
Association between ingestion of medication and the absence or presence of each of the Observations of parents and children as they interact with each other during medication administration. Interactions will be coded by trained observers.
Measured: Up to 5 months
Length of time it takes to administer medication
The association between time to ingestion and the DCIPS coded skills will be analyzed
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Sep 2022
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
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
- NCT05587582
- Sponsor's protocol ID
- I 1832021
- Other IDs
- R01CA258337
- Status last verified
- Feb 2025
- First submitted
- 14 Oct 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. 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: Studies 1 and 2
- ClinicalTrials.gov ID
- NCT05587582
- Acronym / sponsor ID
- I 1832021
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 20 Oct 2022 (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.
This study observes behavioral parenting skills to see whether it could be a novel target for improving pediatric medication adherence. This study may help researchers better understand the challenges parents face when giving their young child with an illness medicine at home and learn about various factors related to medication compliance in young children
Detailed description
PRIMARY OBJECTIVES:
- Use direct observation of medication administration in the home to understand common episode-level barriers and identify the most impactful behavioral parenting skills for intervention.
II. Use daily diary methods to identify contextual barriers to adherence and identify intervention components to help parents anticipate barriers and plan strategies to promote successful adherence.
OUTLINE:
Participants complete a survey over 15-20 minutes at baseline. Family behaviors before, during and after the administration of medication to the child are video-recorded over 40-45 minutes. Participants receive MEMS electronic pill bottle to use for 2 weeks and complete daily survey over 5 minutes for 14 days.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (Family Behaviors) | – | Other: Survey AdministrationPRIMARY OBJECTIVES: I. Use direct observation of medication administration in the home to understand common episode-level barriers and identify the most impactful behavioral parenting skills for intervention. II. Use daily diary methods to identify contextual barriers to adherence and identify intervention components to help parents anticipate barriers and plan strategies to promote successful adherence. OUTLINE: Participants complete a survey over 15-20 minutes at baseline. Family behaviors before, during and after the administration of medication to the child are video-recorded over 40-45 minutes. Participants receive MEMS electronic pill bottle to use for 2 weeks and complete daily survey over 5 minutes for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Families of young children ages 3-9 diagnosed with acute lymphoblastic leukemia within 4 weeks of oral chemotherapy prescription at Roswell Park Cancer Institute (Buffalo, NY) or Oishei Children's Hospital in Buffalo, New York
Key inclusion criteria (11 listed)
- Parent of a child diagnosed within the past month with acute lymphoblastic leukemia (ALL)
- Pediatric patient's age 3 - 9.
- Child on therapy that includes oral mercaptopurine (6-MP) administration
- Parent age 18 - NA (No Limit)
- Parent should have verbal English fluency
Key exclusion criteria (4 listed)
- Pediatric patient is on therapy that does not include oral 6-MP administration
- Cognitively impaired adults/adults with impaired decision-making capacity
- Pediatric patients who are not yet adults (infants under the age of 3, children over 9 years, teenagers)
- Prisoners
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 |
|---|---|---|
| Survey AdministrationComplete a survey | Other | Observational (Family Behaviors) |
Primary outcome
Dyadic Parent-Child Interaction Coding System (DCIPS) - medication ingestion
Time frame: Up to 5 months
Association between ingestion of medication and the absence or presence of each of the Observations of parents and children as they interact with each other during medication administration. Interactions will be coded by trained observers.
Length of time it takes to administer medication
Time frame: Up to 5 months
The association between time to ingestion and the DCIPS coded skills will be analyzed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Lymphoblastic Leukemia
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 3
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
B-cell Acute Lymphoblastic Leukemia
Not yet recruiting
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT
Acute Lymphoblastic Leukemia, Hematopoietic Stem Cell Transplantation
Not yet recruitingPhase 1
BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
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. This study is not recruiting at the moment.
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?
An observational study of Acute Lymphoblastic Leukemia, 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 11 inclusion and 4 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: finished, as of the sponsor's last update on 7 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyadic Parent-Child Interaction Coding System (DCIPS) - medication ingestion (time frame: Up to 5 months). The study lists 2 primary outcomes in all. 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 7 Feb 2025.