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

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Investigation Team
Questionnaires assessed adolescents aged 14-35 years old (including 14,25 years old) who agreed to participate in the study
Other: Questionnaires
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wei XIA, PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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