- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05621278
Children to Adults Mental and Psychosomatic Health Study (CAMPS)
April 23, 2024 updated by: YinyinZang, Peking University
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
400000
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
- Name: Zang Yinyin, PhD
- Phone Number: +86 15553201610
- Email: yinyin.zang@pku.edu.cn
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100871
- Recruiting
- Peking University
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Contact:
- Yinyin Zang
- Phone Number: +86-010-62756953
- Email: yinyin.zang@pku.edu.cn
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Principal Investigator:
- Yinyin Zang, PhD
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-
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
Ages Eligible for Study
9 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Students from 5 grade to 12 grade and their parents and teachers in Chinese schools.
Description
Inclusion Criteria:
- Students from 5 grade to 12 grade, their parents and teachers
- able to read, answer questionnaires and complete experiments.
Exclusion Criteria:
a. Students who suspend schooling.
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 |
|---|
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Students' teachers
School Teachers
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Children
Grade 4 to 6 students (aged 9-12) in primary school.
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Adolescent
Grade 7 to 12 students (aged 12-18) in middle school and high school.
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Students' parents
Parents of students mentioned above.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month
|
|
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.
|
1 month
|
|
Depression for adults
Time Frame: 2 weeks
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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.
|
2 weeks
|
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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.
|
2 weeks
|
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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.
|
2 weeks
|
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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.
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2 weeks
|
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PTSD for adults
Time Frame: 1 month
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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.
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1 month
|
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PTSD for adolescents and children
Time Frame: 1 month
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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.
|
1 month
|
|
NSSI
Time Frame: 1 year
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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.
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1 year
|
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Suicide
Time Frame: 1 year
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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.
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1 year
|
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Emotion recognition
Time Frame: Half year
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The Morph task for adolescents to examine the emotion recognition capability.
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Half year
|
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Excutive function
Time Frame: Half year
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The Go/Nogo task for adolescents is to examine inhibition function.
|
Half year
|
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Adverse Childhood Experiences (ACE)
Time Frame: each year
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A questionnaire measuring adverse childhood experiences with 26 items.
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each year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
September 11, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
September 9, 2022
First Submitted That Met QC Criteria
November 12, 2022
First Posted (Actual)
November 18, 2022
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- CAMPS
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
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