Promoting Safe Use of Children's Cough/Cold Medicines

June 29, 2023 updated by: NYU Langone Health

Identifying "Best Practices" for the Safe Use of Pediatric Cough and Cold Medications

This study seeks to identify ways to help parents safely use cough/cold medications with their children. The study focuses on 3 key tasks that have been found to be difficult for parents: 1) decision-making about whether medicines should be given based on a child's age, 2) use of active ingredient information to determine which medications are safe to give together, and 3) medication dosing.

Specific ways that labels and dosing tools can be changed to improve parent understanding and ability to use pediatric cough and cold medications will be tested. This includes looking at whether including age restriction information on the front panel helps parents make better decisions about whether a medication should be given to a child, as well as whether presence of a specific warning or pictogram can help improve this understanding. In addition, the role of font size, including a box around ingredients, and use of a specific warning to look at and compare active ingredients, will be examined to see if these can help parents decide if two medications can be given together safely. Finally, dosing charts with pictograms of dosing tools, and provision of certain dosing tools, can lead to fewer parent dosing errors.

A label/dosing tool combination that incorporates what is learned from the first part of the study will be developed based on findings from the first part of the study, and then tested to see whether this improves parent understanding and use of pediatric cough and cold medicines.

Hypotheses include: 1) changes in labels and dosing tools, such as including explicit warnings, and pictographic warnings/instructions can improve parent understanding and ability to act on of medication instructions, 2) parents with low health literacy and/or LEP will especially benefit from strategies such as explicit wording, warnings, and pictogram, and 3) parents receiving the comprehensive labeling and dosing strategy will have a better understanding of appropriate use of cough/cold medications, including fewer dosing errors, compared to standard labels.

A multi-part experiment will be conducted. Findings will be merged with known evidence around health literacy best practices to develop a comprehensive, consumer-centered strategy for English and Spanish-speaking parents. Pilot testing of the comprehensive strategy in comparison to existing labels will then take place.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

See Brief summary.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
312

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parent/Legal guardian 18 years or older
  • Parent/Legal guardian with children <6 years old
  • English or Spanish speaking

Exclusion Criteria:

  • Visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
  • Uncorrectable hearing impairment
  • Parents/ children too ill to participate will also be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: No age range / no explicit warning
Label: No age range and no explicit warning on front display panel of medication box.
Other: Label
Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.
Experimental: age range / no explicit warning
Label: Age range present but no explicit warning on front display panel of medication box.
Other: Label
Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.
Experimental: age range / explicit warning in words
Label: Age range present with explicit warning in words on front display panel of medication box.
Other: Label
Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.
Experimental: age range / explicit warning+pictogram
Label: Age range present with explicit warning in words plus pictographic warning on front display panel of medication box.
Other: Label
Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
# of parents making correct decision about whether medication should be given based on age restriction information (survey)
Time Frame: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
# of parents making correct decision about whether medication should be given to their child based on age restriction information, assessed by survey question
on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
# of parents with correct knowledge of age group that medication can be given to (survey)
Time Frame: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
# of parents with correct knowledge of the age of the youngest and oldest child the medication can be given to, assessed by survey questions
on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shonna Yin, MD, NYU School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-01510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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