Research on Disease Control and Mental Health Status of Adolescent Asthma Patients

February 12, 2026 updated by: Kunling Shen, Beijing Children's Hospital

Background: Currently in China, adolescent asthma care is characterized by both undertreatment and overtreatment. Patients in this age group may exhibit negative emotions toward disease treatment and long-term control. Insufficient disease knowledge, irregular lifestyle habits, and negative attitudes toward the disease can all reduce medication adherence, affect disease control outcomes, and thereby increase the risk of severe chronic respiratory conditions and disease burden in adulthood.

Objectives: To assess disease control status in adolescent asthma patients, evaluate the psychological well-being of patients and their family members, and understand patients' self-management skills and readiness for transition to adulthood.

Procedures: Eligible participants will complete a series of assessment questionnaires through the Youran Huxi mobile application, including questionnaires on asthma control, physical activity, psychological health, self-management behaviors, and transition readiness. The study period is 12 months; the baseline assessment involves one-time completion of written questionnaires with no interim follow-up visits. The study does not intervene in clinical diagnosis or treatment decisions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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.
Observational

Enrollment (Estimated)

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.
460

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study recruited children with asthma and their parents from the hospital outpatient clinic as research participants. The inclusion criteria were: meeting the GINA 2025 diagnostic criteria for asthma; children aged 12-18 years; and both parents and children provided informed consent and were able to complete the questionnaires. The exclusion criteria were: children with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis, or pneumonia; and those with other chronic systemic diseases including diabetes, kidney disease, lupus erythematosus, skin diseases, epilepsy, heart disease, or arthritis.

Description

Inclusion Criteria:

  • Meet the asthma diagnostic criteria of GINA 2025
  • Age 12 to 18 years old
  • The parents and the child patient agreed and filled out the questionnaire completely.

Exclusion Criteria:

  • Children with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis and pneumonia
  • Combined with chronic diseases of other systems

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Adolescent asthma patients
Adolescents diagnosed with asthma
Other: Eligible participants will complete a battery of assessment questionnaires
Data on demographic characteristics, asthma control status, anxiety and depression symptoms, self-management self-efficacy, and transition readiness were collected via standardized questionnaires

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
anxiety state
Time Frame: From the diagnosis of asthma to the end of this survey at 12month

Total scores on the Screen for Childhood Anxiety and Related Emotional Disorders (SCARED) ranging from 0 to 24 are considered within the non-clinical range, indicating minimal anxiety symptoms.

SCARED total scores of 25-41 indicate mild to moderate anxiety symptoms. Scores of 42 or above suggest moderate to severe anxiety symptoms, indicating probable anxiety disorder.
From the diagnosis of asthma to the end of this survey at 12month
depression state
Time Frame: From the diagnosis of asthma to the end of this survey at 12month

A score of 16 to 19 on the Child Depression Scale (CDI) indicates mild depressive symptoms, and attention should be paid to psychological state.

A score of 20 to 24 indicates moderate depressive symptoms. A score of 25 or above indicates severe depressive symptoms, suggesting the possible presence of depressive disorders.
From the diagnosis of asthma to the end of this survey at 12month

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
disease control level
Time Frame: From the 4 weeks prior to enrollment to the end of this survey at 12month

The Asthma Control Test (ACT) will be employed for assessment, with the following interpretation criteria:

A total score of 20-25 indicates well-controlled asthma; A score of 16-19 suggests poorly controlled asthma; A score of 5-15 reflects very poorly controlled asthma.
From the 4 weeks prior to enrollment to the end of this survey at 12month
Adolescent readiness for the transition period of asthma
Time Frame: From the diagnosis of asthma to the end of this survey at 12month

The STARx Transition Readiness Questionnaire (scale) is suitable for patients aged 12 to 22 and is filled out by adolescent patients.

There are a total of 6 dimensions, divided into drug management (4 items), doctor-patient communication (3 items), participation in medical visits (3 items), assumption of health responsibility (2 items), disease knowledge (3 items), and resource utilization (3 items), totaling 18 items.

It is divided into five levels from 1 to 5, each assigned a score of 1, 2, 3, 4, and 5 respectively. The transition period preparation score is the sum of the scores of each item.

The higher the score, the more thorough the transition period preparation and the better the self-care ability.
From the diagnosis of asthma to the end of this survey at 12month

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.
Beijing Children's Hospital

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 (Estimated)

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.
April 1, 2026

Primary Completion (Estimated)

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.
October 1, 2027

Study Completion (Estimated)

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.
December 1, 2027

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).
February 6, 2026

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.
February 12, 2026

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.
February 17, 2026

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.
February 17, 2026

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.
February 12, 2026

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.
February 1, 2026

More Information

Terms related to this study

Keywords

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.
  • Adolescent Asthma 001

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

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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