Drug MisuseNCT06714578
Construction of a Risk Screening Tool for New Psychoactive Substance Misuse Among Adolescents and Young Adults
An observational study of Drug Misuse and Addiction, run by Wei XIA, PhD at 1 site in China.
Trial summary
The goal of this observational study is to construct a risk tool available for screening young adults and adolescents at high risk of drug misuse and provides a chance for early intervention to young adults and adolescents at high risk of drug misuse, which prevent the onset and development of drug addiction in the… Read more about this study
- Who is it for?
- Ages 14 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Misuse, Addiction
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 1,035 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to 1 Dec 2025
- 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 14 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents and young adults aging 14-35 years old
Who may be able to join
- Adolescents and young adults who were aged 14-35 years;
- Adolescents and young adults could read and communicate in Chinese were invited to participate in this study
Who cannot join
- Adolescents and young adults who were unable to complete the questionnaire due to physical or psychological reasons.
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
Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wei Xia, PhD, +86 18823359471, xiaw23@mail.sysu.edu.cn
About this study
The goal of this observational study is to construct a risk tool available for screening young adults and adolescents at high risk of drug misuse and provides a chance for early intervention to young adults and adolescents at high risk of drug misuse, which prevent the onset and development of drug addiction in the future.The main question it aims to answer is:
- Explore the occurrence and influencing factors of new psychoactive substance misuse among young adults and adolescents;
- Construct a risk prediction model for new psychoactive substance misuse among young adults and adolescents and conduct internal verification of the model;
- Based on the results of the prediction model, select the optimal model to initially form a concise scale "Screening Tool for the Risk of New Psychoactive Substance Misuse among Young Adults and Adolescents";
- Conduct external verification of the tool, and revise and improve the screening tool, form the final version of the screening tool, and verify the application performance of the screening tool.
- Conditions
- Drug Misuse, Addiction
- Being tested
- Questionnaire and Physical Exam
- Medical subject headings
- Drug Misuse, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
The investigators use questionnaire to assess biological factors (sleep quality, externalizing problem behavior, prosocial tendencies, sensation seeking, and hedonic hunger), psychological factors (risk awareness of drug misusing, indulgence of drug misusing, self-efficacy of drug misusing, and ACEs), and social factors (whether work in a special place, whether have drug-addicts around, cognition of traditional drug types, and cognition of NPS types) and demographic data
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived risks associated with drug abuse
Perceived risks associated with drug abuse developed by the Hong Kong Security Bureau's Narcotics Division is adopted (https://www.nd.gov.hk/tc/beat_questions_2010R2.html). The scale consists of 12 questions and uses a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Unsure, 4 = Agree, 5 = Strongly Agree). The total score ranges from 12 to 60, with a higher score indicating a greater awareness of drug use risks. In this study, the Cronbach's α coefficient for the Chinese version of this scale is 0.931.
Measured: baseline
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index was developed by Buysse et al. [14], and the Chinese version was translated and revised by Xianchen Liu et al. in 1996 [15]. It has been confirmed that the PSQI is suitable for evaluating sleep quality in patients with mental disorders and the general population in China. This scale consists of 19 self-reported items and 5 observer-rated items, of which the 19th self-reported item and the 5 observer-rated items are not included in the scoring. The 18 items comprise seven factors: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale from 0 to 3, with a total score range from 0 to 21. A higher score indicates poorer sleep quality. In this study, the overall Cronbach's α coefficient for the Chinese version of the scale across the seven factors was 0.716.
Measured: baseline
Prosocial Tendencies Measure (PTM)
The Chinese version of the Prosocial Tendencies Measure was revised by Yu Kou, Huifang Hong et al. in 2007 [16]. This scale consists of 26 items, encompassing six dimensions: public, anonymous, altruistic, compliant, emotional, and urgent. It uses a 5-point Likert scale for scoring (1 = very unlike me, 2 = somewhat unlike me, 3 = neutral, 4 = somewhat like me, 5 = very like me). The total score ranges from 26 to 130, with higher scores indicating greater prosocial tendencies. In this study, the Cronbach's α coefficient for the Chinese version of the scale was 0.957, with the Cronbach's α coefficients for the six dimensions of public, anonymous, altruistic, compliant, emotional, and urgent being 0.824, 0.877, 0.845, 0.849, 0.855, and 0.791, respectively.
Measured: baseline
Achenbach Youth Self Report (YSR)
The Youth Self Report (YSR), developed by Achenbach et al. [17], was used in its 2001 version. The Chinese version was translated and revised by Wang Runcheng et al.[18] in 2013. The questionnaire is divided into 8 factors (Anxiety/Depression, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Delinquent Behavior, Aggressive Behavior) and an "Other Problems" item. The Delinquent Behavior and Aggressive Behavior factors together constitute the externalizing symptom group and are widely used to measure externalizing problem behaviors in adolescents. The Delinquent Behavior factor includes 15 items, and the Aggressive Behavior factor includes 17 items, using a three-point scoring scale (0 = not at all true, 1 = somewhat true, 2 = very true). The total score for the two factors ranges from 0 to 96, with higher scores indicating more severe externalizing problem behaviors. In this study, the Cronbach's α coefficients for the Delinquent Behavior
Measured: baseline
Brief Sensation Seeking Scale for Chinese (BSSS-C)
The 8-item Brief Sensation Seeking Scale developed by Hoyle et al.[19] was utilized, with the Chinese version translated and revised by Xinguang Chen et al.[20] in 2013 to measure personality traits related to sensation seeking. This scale comprises 8 items, encompassing four dimensions: Lack of Self-Control, Pursuit of Novelty, Difficulty Tolerating Monotony, and Pursuit of New Experiences. A five-point Likert scale was used for scoring (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The total score ranges from 8 to 40, with higher scores indicating higher levels of sensation seeking. In this study, the Cronbach's α coefficient for the Chinese version of the scale was 0.855.
Measured: baseline
Power of Food Scale (PFS)
The Power of Food Scale developed by Lowe et al.[21] was employed, with the Chinese version translated and revised by Han Xiao, Jianwen Song, Xinni Han et al.[22] in 2023, to measure the level of hedonic hunger. The scale consists of 15 items, which include three dimensions: Food Availability, Food Presence, and Food Taste, utilizing a five-point Likert scale for scoring (1 = I disagree, 2 = I somewhat agree, 3 = I somewhat agree, 4 = I fairly agree, 5 = I completely agree). The total score ranges from 15 to 75, with higher total scores indicating a greater level of hedonic hunger. In this study, the Cronbach's α coefficient for the Chinese version of the scale was 0.940, and the Cronbach's α coefficients for the three dimensions (Food Availability, Food Presence, Food Taste) were 0.866, 0.858, and 0.863, respectively.
Measured: baseline
Permissive attitude towards drug abuse
Permissive attitude towards drug abuse developed by the Hong Kong Security Bureau's Narcotics Division is adopted (https://www.nd.gov.hk/tc/beat_questions_2010R2.html). The scale consists of 21 questions and uses a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Unsure, 4 = Agree, 5 = Strongly Agree). The total score ranges from 21 to 105, with a higher score indicating a higher tolerance attitude towards drug use. In this study, the Cronbach's α coefficient for the Chinese version of this scale is 0.966.
Measured: baseline
Refusal Self-Efficacy Scale (Self-Efficacy List for Drug Users, SELD)
The Refusal Self-Efficacy Scale developed by Gerdien et al.[23] is adopted (Self-Efficacy List for Drug Users, SELD), with the Chinese version translated and revised by Liuna Geng et al.[24], used to measure refusal self-efficacy regarding drugs. The scale consists of 17 questions encompassing three dimensions: environmental factors, negative emotions, and positive emotions, using a 5-point Likert scale (1 = Very Easy to Refuse, 2 = Easy to Refuse, 3 = Unsure, 4 = Somewhat Difficult to Refuse, 5 = Very Difficult to Refuse). The total score ranges from 17 to 85, with a higher score indicating lower refusal self-efficacy. In this study, the Cronbach's α coefficient for the Chinese version of this scale is 0.961, and the Cronbach's α coefficients for the three dimensions (environmental factors, negative emotions, positive emotions) are 0.901, 0.928, and 0.937, respectively.
Measured: baseline
Adverse childhood experiences, ACEs
The Adverse Childhood Experiences Scale developed by the Kaiser-CDC laboratory is adopted to investigate various adverse events experienced by subjects before the age of 18[25]. The scale includes three dimensions: abuse, neglect, and family dysfunction, with a total of 10 items. Each item offers two response options: "Yes" and "No." A "Yes" response is scored as 1 point, while a "No" response is scored as 0 points. The total score is the sum of the scores from each item, reflecting the number of adverse childhood experiences. The total score ranges from 0 to 10, with a higher score indicating more adverse childhood experiences. In this study, the Cronbach's α coefficient for the Chinese version of this scale is 0.760.
Measured: baseline
Peers drug-misuse situation
It is a binary outcome. The investigators will ask for question that "Are there peers around you engage in drug use?" And the participants are supposed to answer "yes" or "no"
Measured: baseline
Work experiences in special venues
The investigators will ask for question that "Do you have any work experience in special venues such as bars or nightclubs?" And the participants are supposed to choose the special venues they used to work including "Bar", "Internet cafe", "Ballroom", "Nightclub", "KTV", "Disco", "Leisure clubhouse", "Agriturismo" or choose "None of the above" if they have never work in such special venues.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug MisuseStudies 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
- 1,035 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714578
- Sponsor's protocol ID
- L2024SYSU-HL-039
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Risk Screening Tool for New Psychoactive Substance Misuse Among Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT06714578
- Acronym / sponsor ID
- L2024SYSU-HL-039
- Conditions
- Drug Misuse, Addiction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,035 participants (estimated)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Dec 2024 (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.
The goal of this observational study is to construct a risk tool available for screening young adults and adolescents at high risk of drug misuse and provides a chance for early intervention to young adults and adolescents at high risk of drug misuse, which prevent the onset and development of drug addiction in the future.The main question it aims to answer is:
- Explore the occurrence and influencing factors of new psychoactive substance misuse among young adults and adolescents;
- Construct a risk prediction model for new psychoactive substance misuse among young adults and adolescents and conduct internal verification of the model;
- Based on the results of the prediction model, select the optimal model to initially form a concise scale "Screening Tool for the Risk of New Psychoactive Substance Misuse among Young Adults and Adolescents";
- Conduct external verification of the tool, and revise and improve the screening tool, form the final version of the screening tool, and verify the application performance of the screening tool.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents and young adults aging 14-35 years old
Key inclusion criteria (2 listed)
- Adolescents and young adults who were aged 14-35 years;
- Adolescents and young adults could read and communicate in Chinese were invited to participate in this study
Key exclusion criteria (1 listed)
- Adolescents and young adults who were unable to complete the questionnaire due to physical or psychological reasons.
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 |
|---|---|---|
| Questionnaire and Physical ExamThe investigators use questionnaire to assess biological factors (sleep quality, externalizing problem behavior, prosocial tendencies, sensation seeking, and hedonic hunger), psychological factors (risk awareness of drug misusing, indulgence of drug misusing, self-efficacy of drug misusing, and ACEs), and social factors (whether work in a special place, whether have drug-addicts around, cognition of traditional drug types, and cognition of NPS types) and demographic data | Other | – |
Primary outcome
Perceived risks associated with drug abuse
Time frame: baseline
Perceived risks associated with drug abuse developed by the Hong Kong Security Bureau's Narcotics Division is adopted (https://www.nd.gov.hk/tc/beat_questions_2010R2.html). The scale consists of 12 questions and uses a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Unsure, 4 = Agree, 5 = Strongly Agree). The total score ranges from 12 to 60, with a higher score indicating a greater awareness of drug use risks. In this study, the Cronbach's α coefficient for the Chinese version of this scale is 0.931.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline
The Pittsburgh Sleep Quality Index was developed by Buysse et al. [14], and the Chinese version was translated and revised by Xianchen Liu et al. in 1996 [15]. It has been confirmed that the PSQI is suitable for evaluating sleep quality in patients with mental disorders and the general population in China. This scale consists of 19 self-reported items and 5 observer-rated items, of which the 19th self-reported item and the 5 observer-rated items are not included in the scoring. The 18 items comprise seven factors: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale from 0 to 3, with a total score range from 0 to 21. A higher score indicates poorer sleep quality. In this study, the overall Cronbach's α coefficient for the Chinese version of the scale across the seven factors was 0.716.
Prosocial Tendencies Measure (PTM)
Time frame: baseline
The Chinese version of the Prosocial Tendencies Measure was revised by Yu Kou, Huifang Hong et al. in 2007 [16]. This scale consists of 26 items, encompassing six dimensions: public, anonymous, altruistic, compliant, emotional, and urgent. It uses a 5-point Likert scale for scoring (1 = very unlike me, 2 = somewhat unlike me, 3 = neutral, 4 = somewhat like me, 5 = very like me). The total score ranges from 26 to 130, with higher scores indicating greater prosocial tendencies. In this study, the Cronbach's α coefficient for the Chinese version of the scale was 0.957, with the Cronbach's α coefficients for the six dimensions of public, anonymous, altruistic, compliant, emotional, and urgent being 0.824, 0.877, 0.845, 0.849, 0.855, and 0.791, respectively.
Achenbach Youth Self Report (YSR)
Time frame: baseline
The Youth Self Report (YSR), developed by Achenbach et al. [17], was used in its 2001 version. The Chinese version was translated and revised by Wang Runcheng et al.[18] in 2013. The questionnaire is divided into 8 factors (Anxiety/Depression, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Delinquent Behavior, Aggressive Behavior) and an "Other Problems" item. The Delinquent Behavior and Aggressive Behavior factors together constitute the externalizing symptom group and are widely used to measure externalizing problem behaviors in adolescents. The Delinquent Behavior factor includes 15 items, and the Aggressive Behavior factor includes 17 items, using a three-point scoring scale (0 = not at all true, 1 = somewhat true, 2 = very true). The total score for the two factors ranges from 0 to 96, with higher scores indicating more severe externalizing problem behaviors. In this study, the Cronbach's α coefficients for the Delinquent Behavior
Brief Sensation Seeking Scale for Chinese (BSSS-C)
Time frame: baseline
The 8-item Brief Sensation Seeking Scale developed by Hoyle et al.[19] was utilized, with the Chinese version translated and revised by Xinguang Chen et al.[20] in 2013 to measure personality traits related to sensation seeking. This scale comprises 8 items, encompassing four dimensions: Lack of Self-Control, Pursuit of Novelty, Difficulty Tolerating Monotony, and Pursuit of New Experiences. A five-point Likert scale was used for scoring (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The total score ranges from 8 to 40, with higher scores indicating higher levels of sensation seeking. In this study, the Cronbach's α coefficient for the Chinese version of the scale was 0.855.
Power of Food Scale (PFS)
Time frame: baseline
The Power of Food Scale developed by Lowe et al.[21] was employed, with the Chinese version translated and revised by Han Xiao, Jianwen Song, Xinni Han et al.[22] in 2023, to measure the level of hedonic hunger. The scale consists of 15 items, which include three dimensions: Food Availability, Food Presence, and Food Taste, utilizing a five-point Likert scale for scoring (1 = I disagree, 2 = I somewhat agree, 3 = I somewhat agree, 4 = I fairly agree, 5 = I completely agree). The total score ranges from 15 to 75, with higher total scores indicating a greater level of hedonic hunger. In this study, the Cronbach's α coefficient for the Chinese version of the scale was 0.940, and the Cronbach's α coefficients for the three dimensions (Food Availability, Food Presence, Food Taste) were 0.866, 0.858, and 0.863, respectively.
Permissive attitude towards drug abuse
Time frame: baseline
Permissive attitude towards drug abuse developed by the Hong Kong Security Bureau's Narcotics Division is adopted (https://www.nd.gov.hk/tc/beat_questions_2010R2.html). The scale consists of 21 questions and uses a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Unsure, 4 = Agree, 5 = Strongly Agree). The total score ranges from 21 to 105, with a higher score indicating a higher tolerance attitude towards drug use. In this study, the Cronbach's α coefficient for the Chinese version of this scale is 0.966.
Refusal Self-Efficacy Scale (Self-Efficacy List for Drug Users, SELD)
Time frame: baseline
The Refusal Self-Efficacy Scale developed by Gerdien et al.[23] is adopted (Self-Efficacy List for Drug Users, SELD), with the Chinese version translated and revised by Liuna Geng et al.[24], used to measure refusal self-efficacy regarding drugs. The scale consists of 17 questions encompassing three dimensions: environmental factors, negative emotions, and positive emotions, using a 5-point Likert scale (1 = Very Easy to Refuse, 2 = Easy to Refuse, 3 = Unsure, 4 = Somewhat Difficult to Refuse, 5 = Very Difficult to Refuse). The total score ranges from 17 to 85, with a higher score indicating lower refusal self-efficacy. In this study, the Cronbach's α coefficient for the Chinese version of this scale is 0.961, and the Cronbach's α coefficients for the three dimensions (environmental factors, negative emotions, positive emotions) are 0.901, 0.928, and 0.937, respectively.
Adverse childhood experiences, ACEs
Time frame: baseline
The Adverse Childhood Experiences Scale developed by the Kaiser-CDC laboratory is adopted to investigate various adverse events experienced by subjects before the age of 18[25]. The scale includes three dimensions: abuse, neglect, and family dysfunction, with a total of 10 items. Each item offers two response options: "Yes" and "No." A "Yes" response is scored as 1 point, while a "No" response is scored as 0 points. The total score is the sum of the scores from each item, reflecting the number of adverse childhood experiences. The total score ranges from 0 to 10, with a higher score indicating more adverse childhood experiences. In this study, the Cronbach's α coefficient for the Chinese version of this scale is 0.760.
Peers drug-misuse situation
Time frame: baseline
It is a binary outcome. The investigators will ask for question that "Are there peers around you engage in drug use?" And the participants are supposed to answer "yes" or "no"
Work experiences in special venues
Time frame: baseline
The investigators will ask for question that "Do you have any work experience in special venues such as bars or nightclubs?" And the participants are supposed to choose the special venues they used to work including "Bar", "Internet cafe", "Ballroom", "Nightclub", "KTV", "Disco", "Leisure clubhouse", "Agriturismo" or choose "None of the above" if they have never work in such special venues.
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 18 Dec 2024.
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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 Drug Misuse and 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 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: opening soon, as of the sponsor's last update on 18 Dec 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 Wei Xia, PhD (+86 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?
Perceived risks associated with drug abuse (time frame: baseline). The study lists 11 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 18 Dec 2024.