Study Proposal for Web Based Intervention to Promote the Safe Usage of Dating Applications in Young Adults

April 17, 2020 updated by: The University of Hong Kong

Study Protocol for a Peer-led Web-based Intervention to Promote Safe Usage of Dating Applications Amongst Young Adults: A Cluster Randomized Controlled Trial

This study will evaluate the effectiveness of a program in promoting the safe usage of dating applications amongst young adults in Hong Kong. One group will receive the program regarding dating applications and the other group will receive a placebo program regarding health and exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dating applications are a popular platform to meet new people; however, they have been associated with risks such as unsafe sexual behavior and privacy concerns in young adults.

The study design is an open-labeled cluster randomized controlled trial with an intervention and a placebo control arm. The intervention group will receive a web-based intervention developed through focus group discussions, crowdsourcing contest, and a Peer-Vetted Creative Production (PVCP) workshop comprising of four short videos, a risk assessment tool, and a scenario game. The control group will receive a web-based resource with similar multimedia elements on health and exercise.

Based on the Information, Motivation, and Behavioral Skills (IMB) Model, the primary outcome of this study is self-efficacy in using dating applications measured by the General Self Efficacy Scale. Secondary outcomes include change in attitudes regarding risk perception measured by the Risk Propensity Scale and depression symptoms.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
578

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Caritas Institute of Community Education
      • Hong Kong, Hong Kong
        • Vocational Training Council (VTC)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 27 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 17-27 years old
  • Able to read and understand Chinese

Exclusion Criteria:

  • Have a physical impediment (e.g. blindness) to prevent them from accessing the content

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention - Dating application topic
The intervention will consist of four short videos with points of discussion, a scenario game, and a risk assessment tool regarding dating application usage.
Behavioral: Intervention - Dating application topic
The intervention will consist of multimedia content to promote the safe usage of dating applications and raise awareness of the risks associated with dating application usage. The intervention will be delivered one-time in a classroom setting.
PLACEBO_COMPARATOR: Control - Health and exercise topic
The control will consist of four short videos with discussion points and an interaction game regarding exercise and healthy living tips.
Behavioral: Control - Health and exercise topic
The placebo control will consist of multimedia content regarding exercise and healthy living. It will be delivered once-time in a classroom setting.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self Efficacy: This Will be Measured by the General Self Efficacy Scale
Time Frame: 8 months
The primary outcome will be the self-efficacy on the safe usage of dating. applications among young adults in Hong Kong. This will be measured by the General Self Efficacy Scale. The General Self Efficacy Scale is a 10-item scale (with 4 level Likert scale ranging from "not true at all" to "exactly true") measuring one's self-belief in completing certain tasks or overcoming difficulties. The total score is calculated by finding the sum of all items with the total score ranging between 10 and 40, with a higher score indicating a higher level of self efficacy.
8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk Taking Tendencies Will be Measured by the The Risk Propensity Scale.
Time Frame: 8 month
Participants' risk taking tendencies will be measured by the The Risk Propensity Scale. It is a 9-item scale measuring general risk-taking tendencies. Each item is rated on a 9 level Likert scale (ranging from "totally disagree" to "totally agree") with the final score ranging from 1-9. A higher score indicates higher risk-taking tendencies.
8 month
Depression Symptoms Will be Measured by the Patient Health Questionnaire-2 (PHQ-2).
Time Frame: 8 month
Participants' risk of depression will be measured by the Patient Health Questionnaire-2 (PHQ-2). This is a 2 item scale (with a 4 level Likert scale ranging from "Not at all" to "Nearly everyday") and the score ranges from 0-6, with a higher score indicating higher risk of depression.
8 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Wong, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 7, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09160275
  • HKUCTR-2512 (REGISTRY: HKU Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will include baseline demographics, dating application usage and behavior, and the primary and secondary outcomes.

IPD Sharing Time Frame

Data will be available 6 months after study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external review panel.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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