Mental Health WellnessNCT05621278
Children to Adults Mental and Psychosomatic Health Study (CAMPS)
An observational study of Mental Health Wellness and Cognitive Function, run by Peking University at 1 site in China.
Trial summary
This study titled the Children to Adults Mental and Psychosomatic Health Study (CAMPS), aims to explore the interplay between mental health, psychosomatic factors, and adverse childhood experiences (ACE) across a broad age range, from school-age children to adults in China. Read more about this study
- Who is it for?
- Ages 9 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness, Cognitive Function, Physical Symptoms
- How many people
- 400,000 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2022to 31 Dec 2026
- 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 9 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Students from 5 grade to 12 grade and their parents and teachers in Chinese schools.
Who may be able to join
- Students from 5 grade to 12 grade, their parents and teachers
- able to read, answer questionnaires and complete experiments.
Who cannot join
- Students who suspend schooling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University
Beijing, Beijing Municipality, 100871
Yinyin Zang, +86-010-62756953, yinyin.zang@pku.edu.cn
Yinyin Zang, PhD
About this study
Official title: Children to Adults Mental and Psychosomatic Health Study (CAMPS): A Longitudinal Cohort Study
This study titled the Children to Adults Mental and Psychosomatic Health Study (CAMPS), aims to explore the interplay between mental health, psychosomatic factors, and adverse childhood experiences (ACE) across a broad age range, from school-age children to adults in China. The study will involve participants from various educational settings, including teachers, students, and parents, who will be recruited through schools. The assessment methodology will combine validated psychometric scales and behavioral experiments to comprehensively evaluate mental and physical health aspects and the impact of ACEs. This integrative approach is designed to illuminate the complex relationships between psychological well-being, somatic symptoms, and early life stressors across different life stages.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Grade 4 to 6 students (aged 9-12) in primary school. | |
| Adolescent | Grade 7 to 12 students (aged 12-18) in middle school and high school. | |
| Students' teachers | School Teachers | |
| Students' parents | Parents of students mentioned above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritability
A 17-item irritability measurement scale, the Peking irritability scale, measures impulsive emotions, thoughts, and behaviors on a 5-point Likert scale (score from 1 to 5, and total score varies from 17 to 85). A higher score represents higher irritability.
Measured: 1 month
Alexithymia
A 36-item Peking alexithymia scale measures thoughts and behaviors that prevent people from feeling or recognizing negative emotions on a 5-point Likert scale (1 to 5, and total scores vary from 36 to 180). A higher score represents more severe alexithymia.
Measured: 1 month
Depression for adults
The 9-item patient health questionnaire (PHQ-9) for adults (score from 0 to 3, and total score varies from 0 to 27). A higher score represents worse depression symptoms.
Measured: 2 weeks
Depression
Children's depression inventory (CDI) for adolescents and children (score from 0 to 2, and total score vary from 0 to 54). A higher score represents worse depression symptoms.
Measured: 2 weeks
Generalized anxiety disorder
The Generalized Anxiety Disorder-7 scale (GAD-7) for adults, adolescents, and children (scored from 0 to 3, and total score from 0 to 21). A higher score represents worse anxiety symptoms.
Measured: 2 weeks
Anxiety and depression for adolescents and children
The Revised Child Anxiety and Depression Scale (RCADS) for adolescents and children (scored from 0 to 3, and total score from 0 to 75). A higher score represents worse anxiety and depression symptoms.
Measured: 2 weeks
PTSD for adults
The PTSD Symptoms Scale-Interview for DSM-5 (PSSI-5) for adults (score from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms.
Measured: 1 month
PTSD for adolescents and children
The Child PTSD Symptom Scale for DSM-5 (CPSS-5) for adolescents and children (scores from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms.
Measured: 1 month
NSSI
The non-suicidal self-injury assessment tool (NSSI-AT-Severity) for adolescents and children (total scores vary from 5 to 16). A higher score represents a worse self-injury situation.
Measured: 1 year
Suicide
The suicidal behaviors questionnaire-revised (SBQ-R) for adolescents and children (total scores vary from 3 to 18). A higher score represents a higher suicide risk.
Measured: 1 year
Emotion recognition
The Morph task for adolescents to examine the emotion recognition capability.
Measured: Half year
Excutive function
The Go/Nogo task for adolescents is to examine inhibition function.
Measured: Half year
Adverse Childhood Experiences (ACE)
A questionnaire measuring adverse childhood experiences with 26 items.
Measured: each year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start11 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 400,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YinyinZang, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621278
- Sponsor's protocol ID
- CAMPS
- Status last verified
- Apr 2024
- First submitted
- 9 Sep 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children to Adults Mental and Psychosomatic Health Study (CAMPS): A Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05621278
- Acronym / sponsor ID
- CAMPS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400,000 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 2022 (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.
This study titled the Children to Adults Mental and Psychosomatic Health Study (CAMPS), aims to explore the interplay between mental health, psychosomatic factors, and adverse childhood experiences (ACE) across a broad age range, from school-age children to adults in China. The study will involve participants from various educational settings, including teachers, students, and parents, who will be recruited through schools. The assessment methodology will combine validated psychometric scales and behavioral experiments to comprehensively evaluate mental and physical health aspects and the impact of ACEs. This integrative approach is designed to illuminate the complex relationships between psychological well-being, somatic symptoms, and early life stressors across different life stages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Grade 4 to 6 students (aged 9-12) in primary school. |
| Adolescent | – | –Grade 7 to 12 students (aged 12-18) in middle school and high school. |
| Students' teachers | – | –School Teachers |
| Students' parents | – | –Parents of students mentioned above. |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Students from 5 grade to 12 grade and their parents and teachers in Chinese schools.
Key inclusion criteria (2 listed)
- Students from 5 grade to 12 grade, their parents and teachers
- able to read, answer questionnaires and complete experiments.
Key exclusion criteria (1 listed)
- Students who suspend schooling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Irritability
Time frame: 1 month
A 17-item irritability measurement scale, the Peking irritability scale, measures impulsive emotions, thoughts, and behaviors on a 5-point Likert scale (score from 1 to 5, and total score varies from 17 to 85). A higher score represents higher irritability.
Alexithymia
Time frame: 1 month
A 36-item Peking alexithymia scale measures thoughts and behaviors that prevent people from feeling or recognizing negative emotions on a 5-point Likert scale (1 to 5, and total scores vary from 36 to 180). A higher score represents more severe alexithymia.
Depression for adults
Time frame: 2 weeks
The 9-item patient health questionnaire (PHQ-9) for adults (score from 0 to 3, and total score varies from 0 to 27). A higher score represents worse depression symptoms.
Depression
Time frame: 2 weeks
Children's depression inventory (CDI) for adolescents and children (score from 0 to 2, and total score vary from 0 to 54). A higher score represents worse depression symptoms.
Generalized anxiety disorder
Time frame: 2 weeks
The Generalized Anxiety Disorder-7 scale (GAD-7) for adults, adolescents, and children (scored from 0 to 3, and total score from 0 to 21). A higher score represents worse anxiety symptoms.
Anxiety and depression for adolescents and children
Time frame: 2 weeks
The Revised Child Anxiety and Depression Scale (RCADS) for adolescents and children (scored from 0 to 3, and total score from 0 to 75). A higher score represents worse anxiety and depression symptoms.
PTSD for adults
Time frame: 1 month
The PTSD Symptoms Scale-Interview for DSM-5 (PSSI-5) for adults (score from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms.
PTSD for adolescents and children
Time frame: 1 month
The Child PTSD Symptom Scale for DSM-5 (CPSS-5) for adolescents and children (scores from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms.
NSSI
Time frame: 1 year
The non-suicidal self-injury assessment tool (NSSI-AT-Severity) for adolescents and children (total scores vary from 5 to 16). A higher score represents a worse self-injury situation.
Suicide
Time frame: 1 year
The suicidal behaviors questionnaire-revised (SBQ-R) for adolescents and children (total scores vary from 3 to 18). A higher score represents a higher suicide risk.
Emotion recognition
Time frame: Half year
The Morph task for adolescents to examine the emotion recognition capability.
Excutive function
Time frame: Half year
The Go/Nogo task for adolescents is to examine inhibition function.
Adverse Childhood Experiences (ACE)
Time frame: each year
A questionnaire measuring adverse childhood experiences with 26 items.
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 24 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness and Cognitive Function, run by Peking University at 1 site in China.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Zang Yinyin, PhD (+86 15553201610, yinyin.zang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritability (time frame: 1 month). The study lists 13 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 24 Apr 2024.