Asthma (Diagnosis)NCT07412119
Research on Disease Control and Mental Health Status of Adolescent Asthma Patients
An observational study of Asthma (Diagnosis) and Adolescent - Emotional Problem, run by Beijing Children's Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma (Diagnosis), Adolescent - Emotional Problem
- What is being tested?
- Eligible participants will complete a battery of assessment questionnaires
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Dec 2027
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Children with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis and pneumonia
- Combined with chronic diseases of other systems
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Asthma (Diagnosis), Adolescent - Emotional Problem
- Being tested
- Eligible participants will complete a battery of assessment questionnaires
- Keywords
- Asthma, adolescent, mental health
- Medical subject headings
- Asthma, Disease, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eligible participants will complete a battery of assessment questionnairesOther
Data on demographic characteristics, asthma control status, anxiety and depression symptoms, self-management self-efficacy, and transition readiness were collected via standardized questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Adolescent asthma patients | Adolescents diagnosed with asthma Receives: Other: Eligible participants will complete a battery of assessment questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety state
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.
Measured: From the diagnosis of asthma to the end of this survey at 12month
depression state
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.
Measured: From the diagnosis of asthma to the end of this survey at 12month
Secondary outcomes (2)
disease control level
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.
Measured: From the 4 weeks prior to enrollment to the end of this survey at 12month
Adolescent readiness for the transition period of asthma
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.
Measured: From the diagnosis of asthma to the end of this survey at 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunling Shen, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412119
- Sponsor's protocol ID
- Adolescent Asthma 001
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Disease Control and Mental Health Status of Adolescent Asthma Patients
- ClinicalTrials.gov ID
- NCT07412119
- Acronym / sponsor ID
- Adolescent Asthma 001
- Conditions
- Asthma (Diagnosis), Adolescent - Emotional Problem
- Keywords
- Asthma, adolescent, mental health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent asthma patients | – | Other: Eligible participants will complete a battery of assessment questionnairesAdolescents diagnosed with asthma |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Children with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis and pneumonia
- Combined with chronic diseases of other systems
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 |
|---|---|---|
| Eligible participants will complete a battery of assessment questionnairesData on demographic characteristics, asthma control status, anxiety and depression symptoms, self-management self-efficacy, and transition readiness were collected via standardized questionnaires | Other | Adolescent asthma patients |
Primary outcome
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.
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.
2 secondary outcomes
disease control level
Time frame: 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
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma (Diagnosis) and Adolescent - Emotional Problem, run by Beijing Children's Hospital.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Kunling Prof.Shen (0755-83008286, hanpengonly1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety state (time frame: From the diagnosis of asthma to the end of this survey at 12month). 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 17 Feb 2026.