Drug AddictionNCT05958641
Construction of Early Warning Model for the New Psychoactive Substances Using in Adolescents
An observational study of Drug Addiction, run by Wei XIA, PhD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Addiction
- What is being tested?
- Questionnaires
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: General adolescents between 14-35 years old
Who may be able to join
- Adolescents aged 14-35 (including 14,35 years old)
- Agree to participate in the studies
Who cannot join
- Be diagnosed with psychological or mental illness
- People that are unconscious, emotionally unstable, or unable to communicate normally
- Patients with severe diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Drug Addiction
- Being tested
- Questionnaires
- Keywords
- risk prediction model, NPS, addiction susceptibility genes, adverse childhood experience, adolescents
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigation Team | Questionnaires assessed adolescents aged 14-35 years old (including 14,25 years old) who agreed to participate in the study Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cognition of NPS
knowledge questionnaire of drug types and risk awareness of drug use will be investigated to know the degree of cognition to NPS
Measured: Baseline
the resistance of NPS
the drug refusal self-efficacy scale and the drug use permissive attitude will be used to measure the the resistance of NPS
Measured: Baseline
the use of NPS
there will be some questions to investigate the drug use conditions
Measured: Baseline
Adverse Childhood Experience
the Chinese version of Adverse Childhood Experience Scale with 10 items will be used to measure the adverse childhood experience
Measured: Baseline
hedonic hunger
the Power of Food Scale with 15 items will be used to measure hedonic hunger
Measured: Baseline
sensation seeking personality
the Brief Sensation Seeking Scale for Chinese with 8 items will be used to measure sensation seeking personality
Measured: Baseline
prosocial behavior
the Prosocial Tendencies Measure with 26 items will be used to measure prosocial behavior
Measured: Baseline
externalizing behavior
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
Measured: Baseline
sleep quality
the Pittsburgh Sleep Quality Index with 9 items will be used to measure adolescents' sleep quality
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start17 Jul 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei XIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958641
- Sponsor's protocol ID
- 202310893
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05958641
- Acronym / sponsor ID
- 202310893
- Conditions
- Drug Addiction
- Keywords
- risk prediction model, NPS, addiction susceptibility genes, adverse childhood experience, adolescents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- 17 Jul 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 24 Jul 2023 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigation Team | – | Other: QuestionnairesQuestionnaires assessed adolescents aged 14-35 years old (including 14,25 years old) who agreed to participate in the study |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- General adolescents between 14-35 years old
Key inclusion criteria (2 listed)
- Adolescents aged 14-35 (including 14,35 years old)
- Agree to participate in the studies
Key exclusion criteria (3 listed)
- Be diagnosed with psychological or mental illness
- People that are unconscious, emotionally unstable, or unable to communicate normally
- Patients with severe diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParticipants 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. | Other | Investigation Team |
Primary outcome
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
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
the use of NPS
Time frame: Baseline
there will be some questions to investigate the drug use conditions
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
hedonic hunger
Time frame: Baseline
the Power of Food Scale with 15 items will be used to measure hedonic hunger
sensation seeking personality
Time frame: Baseline
the Brief Sensation Seeking Scale for Chinese with 8 items will be used to measure sensation seeking personality
prosocial behavior
Time frame: Baseline
the Prosocial Tendencies Measure with 26 items will be used to measure prosocial behavior
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
sleep quality
Time frame: Baseline
the Pittsburgh Sleep Quality Index with 9 items will be used to measure adolescents' sleep quality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Wei Xia, PhD principal investigator
Sun Yat-sen University
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 Drug Addiction, run by Wei XIA, PhD 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 3 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia, PhD (18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the cognition of NPS (time frame: Baseline). The study lists 9 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 Jul 2023.