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RecruitingNCT06435234Updated Oct 10, 2024

Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory

An interventional study of risky sexual behavior intervention in Unsafe Sex, sponsored by Rong Zhang. Recruiting at 1 site in China. Open to participants aged 16 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Rong Zhang · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
16 Years to 24 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Unsafe Sex

Keywords

  • Risky sexual behavior
  • BCW
  • college students
  • intervention program
  • unsafe sex
03

In context

Lead sponsor

Rong Zhang is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. aged ≥16 years;
  2. full-time undergraduate college students;
  3. 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;
  4. able to clearly recall and describe the incident;
  5. signed an informed consent form

Exclusion criteria

Exclusion Criteria:

  1. not wanting to be asked sex-related questions;
  2. 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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    intervention group

    Behavioral: risky sexual behavior intervention

  • No intervention
    control group

Interventions

  • Behavioralrisky sexual behavior intervention

    Intervening in risky sexual behaviors among college students

06

What researchers measure

Primary outcomes

  1. Sexual mental health

    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

    Time frame: pre-intervention(T0); At the end of the intervention(12 weeks, T1)

  2. Social Support

    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

    Time frame: pre-intervention(T0); At the end of the intervention(12 weeks, T1)

  3. Sexual self-efficacy

    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

    Time frame: pre-intervention(T0); At the end of the intervention(12 weeks, T1)

07

Study locations

1 of 1 sites recruiting
  • Daqing City, Heilongjiang Province
    Daqing, Heilongjiang 163000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Non-disclosure of study data due to ethical requirements and protection of subjects' privacy

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06435234
Lead sponsor
Rong Zhang
Responsible party
Rong Zhang (Principal Investigator, Harbin Medical University) — Sponsor-investigator
First posted
May 30, 2024
Start date
Sep 29, 2024
Primary completion
Dec 2024 (estimated)
Completion
Apr 2025 (estimated)
Last update
Oct 10, 2024

Study contacts

rong Z zhang, bachelor
Contact
zhangrong15576@163.com
15209929032 ext. 18699990225

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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