- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06714578
Construction of a Risk Screening Tool for New Psychoactive Substance Misuse Among Adolescents and Young Adults
December 13, 2024 updated by: Wei XIA, PhD
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1035
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: +86 18823359471
- Email: xiaw23@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510080
- Sun Yat-sen University
-
Contact:
- Wei Xia, PhD
- Phone Number: +86 18823359471
- Email: xiaw23@mail.sysu.edu.cn
-
-
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
Adolescents and young adults aging 14-35 years old
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Adolescents and young adults who were unable to complete the questionnaire due to physical or psychological reasons.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
|
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
|
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
|
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"
|
baseline
|
|
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.
|
baseline
|
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 (Estimated)
December 15, 2024
Primary Completion (Estimated)
August 15, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
November 27, 2024
First Submitted That Met QC Criteria
November 27, 2024
First Posted (Actual)
December 3, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 13, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L2024SYSU-HL-039
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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