NCT04597996

Brief Summary

Mental health literacy is a concept that aims to improve the skills of individuals to overcome difficulties in providing the appropriate help they need in this area. It provides individuals with motivation in this area such as informing and taking responsibility in the field of mental health, directing their behavior, facilitating access to and obtaining information, understanding, evaluating, using, and maintaining information. Objective: This project aims to examine the effect of web-based mental health literacy intervention carried out by school nurses on students' level of knowledge, help-seeking and stigmatization attitudes. Method: Randomized Controlled Trial Research design (pre-test post-test control group design) will be used in the project. The data will be collected through the Mental Health Literacy Scale for Children and Adolescents (MHLS), Attitude Scale for Seeking Psychological Help-Short Form (ASPH-S), Self-Stigma in Seeking Psychological Help Scale (SSSPHS) and the sociodemographic Question Form. The project will be carried out with the students of a secondary school and a high school in the district of Balçova, İzmir province. Sampling calculation Based on the analysis of variance in repeated measurements in 2 groups in the G Power program, Type1 Error 0.05 (alpha 5%) Type2 Error 0.20 (80% power), the sample size calculated in duplicate measurements with medium effect size is 43 participants for each group (Intervention-Control) calculated. Considering that there might be losses during data collection, it is planned to include 50 students for the intervention group and 50 students for the control group. Analysis of variance will be used in the evaluation of data, number, percentage, and descriptive statistics, and in repeated measures to evaluate the effect of the intervention The training modules to be prepared within the scope of the project will focus on the mental health literacy level of the child, attitudes to seek help and stigmatization. Among the teaching materials planned to be prepared for this purpose, there will be short animated course videos, video course contents, and audio presentations. In the study, where web-based education is planned, teaching materials will be delivered to students through the learning management system. Teaching materials and learning management systems will be designed in accordance with mobile technologies and access will be provided from smartphones, tablet computers, and similar mobile devices. During the teaching material development phase, firstly, educational content drafts (storyboards) will be created and presented to field experts, and their opinions on content, teaching approach, methods and techniques, and visual design principles will be taken. Pilot studies will be conducted to understand the educational content during the improvement phase of the developed teaching material designs. It is planned to finalize the training content in light of user feedback.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

October 16, 2020

Last Update Submit

April 6, 2022

Conditions

Keywords

Web BasedHealth EducationSchool NurseMental Health LiteracyAdolescentsStudents

Outcome Measures

Primary Outcomes (3)

  • Mental Health Literacy Scale for Children and Adolescents (MHLS)

    It is a three-point Likert-type scale consisting of two items multiple choice, one item open-ended, two items 8 sub-dimensions (Parents, Friends, Clergyman, Psychologist, Counselor, Psychiatrist, Family Doctor, Teacher) (not suitable - not sure - suitable) has the option to answer. The lowest value that can be taken from the scale varies between 0 and the highest value: 6. (question 1: 1 point, question 3: 2 points, question 4: 2 points, question 5: 1 point).

    3 MONTH

  • Attitude Scale for Seeking Psychological Help-Short Form (ASPH-S)

    It consists of a two-factor structure that includes positive (12 items) and negative (6 items) seeking psychological help, explaining 52.6% of the total variance. The scale, which consists of 5 Likert-type categories, is scored as Fully Agree, Strongly Agree, Undecided, Somewhat Agree, and Never Disagree. (Fully Agree = 5, Strongly Agree = 4, Undecided = 3 Somewhat Agree = 2, Not at all = 1) 6 items of the scale are calculated by scoring in reverse. These items are: 2, 8, 12, 13, 16, 17.The score that can be obtained from the scale is between 18 and 90, and the low score indicates that there is no need for help.

    3 MONTH

  • Self-Stigma in Seeking Psychological Help Scale (SSSPHS)

    The scale is a 5-point Likert type one-dimensional scale with 10 items. Some items of the scale are scored reversely, and high scores indicate the high level of self-stigma in asking for help. Some items of the scale are scored inversely, and a high score indicates a high level of self-stigma in asking for help.

    3 MONTH

Study Arms (2)

Web Based Education

EXPERIMENTAL

A pre-test will be applied. Web-based education will be conducted. The post-test will be applied twice, the first one to be performed 4 weeks after Web-based education is completed and the second one 3 months after Web-based education is completed.

Other: web based education for students

No Intervention Group

NO INTERVENTION

The control group will not have any intervention during the study.

Interventions

Web-based education will include modules on the following subjects; * Mental health literacy knowledge level * Improving help-seeking behavior * Avoiding self-stigmatization in seeking psychological help

Web Based Education

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between the ages of 12-18 (inclusive)
  • volunteering to participate
  • having the access to internet
  • knowing how to use the internet
  • without visual impairment
  • without hearing impairment
  • without perceptual impairment

You may not qualify if:

  • not volunteering to participate
  • not having the access to internet
  • not knowing how to use the internet
  • with visual impairment
  • with hearing impairment
  • with perceptual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • ozlem ozkan salkim

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR
  • Seyda OZBICAKCI, Assoc. Prof

    Dokuz Eylul University

    STUDY DIRECTOR
  • Yasemin KAHYAOĞLU ERDOĞMUŞ, PhD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ozlem ozkan salkim, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
students
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pre test post test model design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Public Health Nursing PhD student

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 22, 2020

Study Start

April 1, 2022

Primary Completion

September 1, 2022

Study Completion

February 1, 2023

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share