NCT06435234

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

May 24, 2024

Last Update Submit

October 8, 2024

Conditions

Keywords

Risky sexual behaviorBCWcollege studentsintervention programunsafe sex

Outcome Measures

Primary Outcomes (3)

  • 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

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

  • 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

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

  • 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

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

Study Arms (2)

intervention group

EXPERIMENTAL
Behavioral: risky sexual behavior intervention

control group

NO INTERVENTION

Interventions

Intervening in risky sexual behaviors among college students

intervention group

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daqing City, Heilongjiang Province

Daqing, Heilongjiang, 163000, China

RECRUITING

MeSH Terms

Conditions

Unsafe Sex

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Central Study Contacts

rong Z zhang, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 30, 2024

Study Start

September 29, 2024

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Non-disclosure of study data due to ethical requirements and protection of subjects' privacy

Locations