Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07412119

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eligible participants will complete a battery of assessment questionnaires

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kunling Prof.Shen

CONTACT

[email protected]

0755-83008286

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.