NCT07412119

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

February 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

February 6, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

Asthmaadolescentmental health

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From the diagnosis of asthma to the end of this survey at 12month

Secondary Outcomes (2)

  • disease control level

    From the 4 weeks prior to enrollment to the end of this survey at 12month

  • Adolescent readiness for the transition period of asthma

    From the diagnosis of asthma to the end of this survey at 12month

Study Arms (1)

Adolescent asthma patients

Adolescents diagnosed with asthma

Other: Eligible participants will complete a battery of assessment questionnaires

Interventions

Data on demographic characteristics, asthma control status, anxiety and depression symptoms, self-management self-efficacy, and transition readiness were collected via standardized questionnaires

Adolescent asthma patients

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaDiseasePsychological Well-Being

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Central Study Contacts

Kunling Prof.Shen

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02