- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05958641
Construction of Early Warning Model for the New Psychoactive Substances Using in Adolescents
July 21, 2023 updated by: Wei XIA, PhD
Early Warning Model Construction on Cognition, Resistance and Using Risk of the New Psychoactive Substances in Adolescents Based on Behavioral Expression of Addiction Susceptibility Genes and Adverse Childhood Experience
Based on the biological-psychology-sociological medicine pattern, this study aims to construction an early warning model of the New Psychoactive Substances (NPS) using for adolescents aged 14-35 years old.
This study intends to obtain the data related to the behavioral expression of addiction susceptibility genes, adverse childhood experience, cognition, resistance and the use of NPS in adolescents by questionnaire survey (sample size: 200), and then use logistic regression and machine learning to construct an early warning model.
Study Overview
Detailed Description
Based on the biological-psychology-sociological medicine pattern, this study aims to construction an early warning model on the use of the New Psychoactive Substances using for adolescents aged 14-35 years old.
This study intends to conduct a questionnaire survey (sample size 200) to obtain data related to the behavioral expression of addiction susceptibility genes, childhood adversity experience, cognition, resistance and the use of NPS in adolescents from different regions and different populations.
Through data analysis, this study aims to get the weight of different risk factors on NPS use, and then use logistic regression and machine learning to construct an early warning model, so as to screen out high-risk groups.
At the same time, the expert group was consulted to establish a risk early warning system to provide a basis for intervention.
Study Type
Observational
Enrollment (Estimated)
200
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: wei Xia, PhD
- Phone Number: 18823359471
- Email: xiaw23@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Sun Yat-sen University
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
General adolescents between 14-35 years old
Description
Inclusion Criteria:
- Adolescents aged 14-35 (including 14,35 years old)
- Agree to participate in the studies
Exclusion Criteria:
- Be diagnosed with psychological or mental illness
- People that are unconscious, emotionally unstable, or unable to communicate normally
- Patients with severe diseases
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 |
Intervention / Treatment |
|---|---|
|
Investigation Team
Questionnaires assessed adolescents aged 14-35 years old (including 14,25 years old) who agreed to participate in the study
|
Participants will be asked to complete the questionnaire including general demographic information, the cognition, resistance and use of NPS as well as the behavioral expression of addiction susceptibility genes and adverse childhood experience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the cognition of NPS
Time Frame: Baseline
|
knowledge questionnaire of drug types and risk awareness of drug use will be investigated to know the degree of cognition to NPS
|
Baseline
|
|
the resistance of NPS
Time Frame: Baseline
|
the drug refusal self-efficacy scale and the drug use permissive attitude will be used to measure the the resistance of NPS
|
Baseline
|
|
the use of NPS
Time Frame: Baseline
|
there will be some questions to investigate the drug use conditions
|
Baseline
|
|
Adverse Childhood Experience
Time Frame: Baseline
|
the Chinese version of Adverse Childhood Experience Scale with 10 items will be used to measure the adverse childhood experience
|
Baseline
|
|
hedonic hunger
Time Frame: Baseline
|
the Power of Food Scale with 15 items will be used to measure hedonic hunger
|
Baseline
|
|
sensation seeking personality
Time Frame: Baseline
|
the Brief Sensation Seeking Scale for Chinese with 8 items will be used to measure sensation seeking personality
|
Baseline
|
|
prosocial behavior
Time Frame: Baseline
|
the Prosocial Tendencies Measure with 26 items will be used to measure prosocial behavior
|
Baseline
|
|
externalizing behavior
Time Frame: Baseline
|
17 items of aggressive behavior and 15 items of rule-breaking behavior from the Chinese Version of Achenbach Youth Self-Report-2001 Version will be used to measure adolescents' degree of externalizing behavior
|
Baseline
|
|
sleep quality
Time Frame: Baseline
|
the Pittsburgh Sleep Quality Index with 9 items will be used to measure adolescents' sleep quality
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wei Xia, PhD, Sun Yat-sen University
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 (Estimated)
July 17, 2023
Primary Completion (Estimated)
October 31, 2023
Study Completion (Estimated)
November 30, 2023
Study Registration Dates
First Submitted
July 16, 2023
First Submitted That Met QC Criteria
July 21, 2023
First Posted (Estimated)
July 24, 2023
Study Record Updates
Last Update Posted (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202310893
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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