## Protocol Section
### Identification Module
**NCT ID:** NCT06435234

**Brief Title:** Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory

**Official Title:** Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory

#### Organization Study ID Info
**ID:** HMUDQ20231116201
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Rong Zhang

#### Responsible Party

**Investigator Affiliation:** Harbin Medical University

**Investigator Full Name:** Rong Zhang

**Investigator Title:** researcher

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Risky Sexual Behavior; BCW; College Students; Intervention Program

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: risky sexual behavior intervention

**Label:** intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- intervention group

**Description:** Intervening in risky sexual behaviors among college students

**Name:** risky sexual behavior intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Sexual mental health

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

**Description:** 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

**Measure:** Social Support

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

**Description:** 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

**Measure:** Sexual self-efficacy

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

### Eligibility Module

**Eligibility Criteria:** 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: (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)

**Healthy Volunteers:** True

**Maximum Age:** 24 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### IPD Sharing Statement Module

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

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
