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AdolescentADOLESCENTSNCT06935981

Effectiveness of School-based Mental Health Program

A study testing school-based mental health program in people with Adolescent and Mental Health, run by Neslihan Lok at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim: This article presents the planned protocol for a study investigating the effects of an eight-week nursing intervention to be implemented in school on positive mental health and self-confidence levels of adolescents. Design: This study protocol describes a randomized controlled trial with a parallel group design. Read more about this study

Who is it for?
Ages 14 to 16 weeksHealthy volunteers can take part
Conditions the study is for
Adolescent, Mental Health, Mental Health Care
What is being tested?
school-based mental health program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Nov 2024to 15 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 16 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • • 9th grade students who agreed to participate in the study
  • Those who scored 78 and below on the Positive Mental Health Scale
  • Those who scored 3.5 and below on the Self-Confidence Level Scale

Who cannot join

  • • Those who have any mental illness,
  • Those who participate in a similar program.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erbil Koru Anadolu Lisesi

    Konya, Selçuklu, 42070

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of School-Based Mental Health Program on Positive Mental Health and Self-Esteem Levels in Adolescents

Aim: This article presents the planned protocol for a study investigating the effects of an eight-week nursing intervention to be implemented in school on positive mental health and self-confidence levels of adolescents.

Design: This study protocol describes a randomized controlled trial with a parallel group design.

Read more

Method: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist is used in this study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. The research population consists of 310 students studying in the 9th grade at Erbil Koru Anatolian High School located in Selçuklu district of Konya province. A total of 66 students were determined as intervention (33) and control (33) who met the inclusion and exclusion criteria. Nursing interventions will last for 8 weeks and consist of education, counseling and homework.

Conclusion: The results obtained from this study may help protect and develop the mental health of adolescents and guide future mental health programs.

Read the detailed description

Purpose of the Study

The purpose of this study was to investigate the effects of an eight-week nursing intervention implemented in school on positive mental health and self-esteem. The specific objectives were as follows:

  • to analyze the effectiveness of the intervention (education and counseling, and psychoeducation of nursing practices) in increasing positive mental health.
  • to evaluate the feasibility of the intervention. Hypotheses H1: The positive mental health level of the intervention group receiving the School-Based Mental Health Program is higher than the control group.

H2: The self-esteem level of the intervention group receiving the School-Based Mental Health Program is higher than the control group.

Method The study is a randomized controlled trial with a parallel group design. It was prepared based on the Standard Protocol Items: Recommendations for Interventional Trials (Chan et al., 2013) and complies with the Consolidation Standards of Reporting Trials (CONSORT) statement (Moher et al., 2012).

Inclusion Criteria:

  • 9th grade students who agree to participate in the study
  • Those who score 78 or below on the Positive Mental Health Scale
  • Those who score 3.5 or below on the Self-Confidence Level Scale

Exclusion Criteria:

  • Those who have any mental illness,
  • Those who participate in a similar program.

Exclusion Criteria:

  • Those who do not attend at least 2 educational program sessions,
  • The student or parent wants to leave the sessions. Randomization Students will be randomly assigned to the intervention and control groups. In order to reduce selection bias and control variables that may have an effect on the outcome variables, participants will be assigned to the experimental and control groups using the simple randomization method by a statistician other than the researcher. The intervention and control group sets will be created using the research randomizer computer program (www.randomizer.org). It will be ensured that the study complies with the inclusion-exclusion criteria and that each group consists of 33 students . Post-tests will be administered by an interviewer to avoid bias.

Outcome Measurements The results of the study will consist of positive mental health level (primary outcome) and self-confidence level (secondary outcome). Data will be collected using Participant Information Form, Personal Information Form, Positive Mental Health Scale and Self-Confidence Scale.

Personal Information Form A data form consisting of 10 questions based on literature and sociodemographic characteristics (age, gender, perceived health status, parental education status, parental attitude, perceived income level, school liking, participation in social activities, chronic mental illness status) prepared by the researcher.

Positive Mental Health Scale Positive mental health, defined as the presence of general emotional, psychological and social well-being, is an important factor of general mental health. It was developed by Lluch (1999) in order to define the concept of positive mental health and to evaluate the level of positive mental health. Its validity and reliability in Turkish were performed by Teke and Baysan Arabacı (2018). The four-point Likert-type scale, consisting of thirty-nine statements and six subgroups, has direct and reverse items. The sub-dimensions of the scale are; personal satisfaction (self-esteem, positive outlook on the future) (4, 6, 7, 12, 14, 31, 38, 39), prosocial attitude (altruistic social attitude, acceptance of different social characteristics) (1, 3, 23, 25, 37), self-control (skills for effectively coping with crisis and stress situations) (2, 5, 21, 22, 26), autonomy (ability to control one's behavior) (10, 13, 19, 33, 34), problem solving and self-actualization (developed decision-making abilities) (15, 16, 17, 27, 28, 29, 32, 35, 36), interpersonal relationship skills (empathy, understanding emotions) (8, 9, 11, 18, 20, 24, 30). Each item of the scale receives a score ranging from "4" to "1" for "always or almost always," "often," "sometimes," and "never or rarely," respectively. Statements 1, 2, 3, 6, 7, 8, 9, 10, 12, 13, 14, 19, 24, 30, 31, 33, 34, 38, and 39 are reverse statements and their scores are reversed. The scores to be obtained from the scale range from 39 to 156. High scores to be obtained from the scale indicate a high level of positive mental health. In the Turkish validity and reliability study, the Cronbach Alpha coefficient for the whole was found to be 0.93 and the Cronbach Alpha coefficients for the subscales were found to be αKM=0.80, αPT=0.86, αÖD=0.78, αÖ=0.86, αPÇKG=0.80 and αKIB=0.83 (Lluch, 1999; Teke and Baysan Arabacı, 2018).

Self-Confidence Scale The Self-Confidence Scale developed by Akın (2007) was used to assess the self-confidence levels of adolescents. The scale includes a 5-choice rating consisting of 33 items and two sub-dimensions as internal self-confidence and external self-confidence. There is no reverse item in the scale. The highest score that can be obtained from this scale is 165, and the lowest score is 33. The scale has two sub-dimensions as internal self-confidence and external self-confidence. It consists of items such as internal self-confidence (1, 3, 4, 5, 7, 9, 10, 12, 15, 17, 19, 21, 23, 25, 27, 30, 32) and external self-confidence (2, 6, 8, 11, 13, 14, 16, 18, 20, 22, 24, 26, 28, 29, 31, 33). By dividing the total score obtained from the scale by the number of items (33), a conclusion can be reached about the self-confidence level of the individual. A score below 2.5 on the Self-Confidence Scale indicates low, between 2.5 and 3.5 indicates medium, and 3.5 and above indicates high self-confidence. The Cronbach's alpha coefficients of the self-confidence scale for the whole scale are; 0.83, and 0.83 and 0.85 for the internal self-confidence and external self-confidence subscales, respectively (Akın, 2007).

Dependent Variables

  • Positive Mental Health Scale Mean Score
  • Self-Confidence Scale Mean Score

Independent Variables

  • School-Based Mental Health Development Program Control Variables
  • Sociodemographic characteristics (age, gender, parental education status of students) Study Procedure This study is a randomized controlled trial consisting of two groups, one intervention group and one control group. Adolescents in the intervention group will be provided with group education, counseling service, and homework assignments, and homework assignments will be used as reminders after the education. No intervention will be applied to the participants in the control group. Pretests and approval for participation in the study will be completed by the researchers before randomization, and posttests will be completed by the interviewer after the psychoeducation is completed. The study will last 8 weeks. Intervention Group: Education, counseling and homework will be applied to the intervention group. Post-tests will be applied at the end of week 8. Control Group: No intervention will be applied to the control group and post-tests will be applied at the end of week 8. After the post-tests are completed, the mental health education given to the intervention group will also be given to the control group.

Intervention and Time Content School-Based Mental Health Program's Topics Week 1 Session 1-Beginning-Getting Acquainted Week 2 Session 2-Emotion, Thought and Behavior Wheel Week 3 Session 3- Optimism Week 4 Session 4- Forgiveness Week 5 Session 5- Saying No Week 6 Session 6- Effective Communication Week 7 Session 7- Problem Solving Week 8 Session 8- Saying Goodbye

Being tested
school-based mental health program
Keywords
Positive mental health, Self-confidence, Mental health program, Adolescence, Psychiatric nursing
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • school-based mental health programOther

    Also called guidance

    Week 1 Session 1-Beginning-Getting Acquainted Week 2 Session 2-Emotion, Thought and Behavior Wheel Week 3 Session 3- Optimism Week 4 Session 4- Forgiveness Week 5 Session 5- Saying No Week 6 Session 6- Effective Communication Week 7 Session 7- Problem Solving Week 8 Session 8- Saying Goodbye

Study groups in NCT06935981
Study groupRoleWhat they receive
intervention groupExperimentalNursing interventions will last 8 weeks and consist of education, counseling and homework.
Receives: Other: school-based mental health program
control groupNo interventionNo intervention will be performed and 8 weeks of nursing interventions will be applied after the final tests are collected.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive Mental Health Scale

    Positive mental health, defined as the presence of general emotional, psychological and social well-being, is an important factor of general mental health. It was developed by Lluch (1999) in order to define the concept of positive mental health and to evaluate the level of positive mental health. Its validity and reliability in Turkish were performed by Teke and Baysan Arabacı (2018). The four-point Likert-format scale consisting of thirty-nine statements and six subgroups has reverse and direct items. The sub-dimensions of the scale are; personal satisfaction (self-esteem, positive outlook on the future) (4, 6, 7, 12, 14, 31, 38, 39), prosocial attitude (altruistic social attitude, acceptance of different social characteristics) (1, 3, 23, 25, 37), self-control (skills for effectively coping with crisis and stress situations) (2, 5, 21, 22, 26), autonomy (ability to control one's behavior) (10, 13, 19, 33, 34), problem solving and self-actualization (developed decision-making abilit

    Measured: From enrollment to the end of training at 8 weeks

  2. Self confidence scale

    In order to assess the self-confidence levels of adolescents, the Self-Confidence Scale developed by Akın (2007) was used. The scale includes 33 items and a 5-option rating consisting of two subdimensions as internal self-confidence and external self-confidence. There are no reverse items in the scale. The highest score that can be obtained from this scale is 165, and the lowest score is 33. The scale has two subdimensions as internal self-confidence and external self-confidence. It consists of items internal self-confidence (1, 3, 4, 5, 7, 9, 10, 12, 15, 17, 19, 21, 23, 25, 27, 30, 32) and external self-confidence (2, 6, 8, 11, 13, 14, 16, 18, 20, 22, 24, 26, 28, 29, 31, 33). By dividing the total score from the scale by the number of items (33), a conclusion can be reached about the individual's self-confidence level. A score below 2.5 indicates low self-confidence, between 2.5 and 3.5 indicates medium self-confidence, and 3.5 and above indicates high self-confidence. The Cronbach a

    Measured: From enrollment to the end of training at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study start5 Nov 2024
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study protocol describes a randomized controlled trial with a parallel group design.
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935981
Sponsor's protocol ID
SelçukU-ZAYDIN-001
Other IDs
23212017
Acronym
ADOLESCENTS
Status last verified
Apr 2025
First submitted
5 Apr 2025
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing school-based mental health program in people with Adolescent and Mental Health, run by Neslihan Lok at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Mental Health Scale (time frame: From enrollment to the end of training at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

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