- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06435234
Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory
October 8, 2024 updated by: Rong Zhang
Using the intervention functions of Behavior Change Wheel (BCW) and BCTs, we constructed an intervention program for college students' risky sexual behaviors by combining literature analysis, qualitative research, Delphi's expert correspondence, and pre-experiment (20 students in the test group and 20 students in the control group).
Before the intervention (T0) and at the end of the intervention (12 weeks, T1), we measured students' psychosexual health, social support, and sexual self-efficacy using relevant scales to ensure the effectiveness of the intervention.
By clarifying the influencing factors of college students' risky sexual behaviors, the proposed intervention program for college students' risky sexual behaviors can effectively reduce the incidence of college students' risky sexual behaviors, improve the level of college students' psychosexual health, increase the level of social support, improve the sense of sexual self-efficacy, improve the level of risk perception, enhance the ability of risky decision-making, reduce the risky behaviors, and reduce the occurrence of adverse outcomes, thus providing a reference and reference for the prevention and control of college students' risky sexual behaviors.
This will provide reference for the prevention and control of risky sexual behaviors among college students.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
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: rong Z zhang, bachelor
- Phone Number: 18699990225 15209929032
- Email: zhangrong15576@163.com
Study Locations
-
-
Heilongjiang
-
Daqing, Heilongjiang, China, 163000
- Recruiting
- Daqing City, Heilongjiang Province
-
-
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
Description
Inclusion Criteria:
- aged ≥16 years;
- full-time undergraduate college students;
- engaged in risky sexual behaviors (including multiple sexual partners, unprotected sex, and casual sex, and one of them is considered to have engaged in risky sexual behaviors) during their college years;
- able to clearly recall and describe the incident;
- signed an informed consent form
Exclusion Criteria:
- not wanting to be asked sex-related questions;
- being screened at the beginning of the semester using the Mental Health Survey and diagnosed by a psychiatrist as having a mental illness (schizophrenia, major depressive disorder, bipolar disorder)
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Experimental: intervention group
|
Intervening in risky sexual behaviors among college students
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual mental health
Time Frame: pre-intervention(T0); At the end of the intervention(12 weeks, T1)
|
Questionnaire on Sexual Mental Health of College Students.A total of 31 entries were made, each of which was scored using a Likert 5 scale (1=completely disagree, 5=completely agree), with 25 items scored positively and 6 items scored negatively. Total scores ranged from 31-155, with higher scores indicating lower levels of psychosexual health |
pre-intervention(T0); At the end of the intervention(12 weeks, T1)
|
|
Social Support
Time Frame: pre-intervention(T0); At the end of the intervention(12 weeks, T1)
|
Social Support Rating Scale for College Students.There are 17 entries in total.
Each entry was scored on a Likert 5-point scale (1=very non-compliant, 5=very compliant), with a total score range of 17-85, with higher scores indicating that 5-point Likert scale (1=very poorly met, 5=very well met), with a total score ranging from 17-85, with higher scores indicating that college students received more social support
|
pre-intervention(T0); At the end of the intervention(12 weeks, T1)
|
|
Sexual self-efficacy
Time Frame: pre-intervention(T0); At the end of the intervention(12 weeks, T1)
|
Sexual Self-Efficacy Scale.There are a total of 34 entries.
The first five dimensions were each scored on a 5-point Likert scale (1=strongly disagree, 5=strongly agree), and the last two dimensions were each scored on a scale of 0 (never) to -4 (more than 5 times), for a total score of 130, with higher scores indicating higher sexual self-efficacy
|
pre-intervention(T0); At the end of the intervention(12 weeks, T1)
|
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 (Actual)
September 29, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
May 24, 2024
First Submitted That Met QC Criteria
May 24, 2024
First Posted (Actual)
May 30, 2024
Study Record Updates
Last Update Posted (Actual)
October 10, 2024
Last Update Submitted That Met QC Criteria
October 8, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- HMUDQ20231116201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Non-disclosure of study data due to ethical requirements and protection of subjects' privacy
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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