NCT06935981

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 5, 2025

Last Update Submit

April 12, 2025

Conditions

Keywords

Positive mental healthSelf-confidenceMental health programAdolescencePsychiatric nursing

Outcome Measures

Primary Outcomes (2)

  • 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

    From enrollment to the end of training at 8 weeks

  • 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

    From enrollment to the end of training at 8 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

Nursing interventions will last 8 weeks and consist of education, counseling and homework.

Other: school-based mental health program

control group

NO INTERVENTION

No intervention will be performed and 8 weeks of nursing interventions will be applied after the final tests are collected.

Interventions

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

Also known as: guidance
intervention group

Eligibility Criteria

Age14 Weeks - 16 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erbil Koru Anadolu Lisesi

Konya, Selçuklu, 42070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Counseling

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Neslihan Lök, Prof. Dr.

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study protocol describes a randomized controlled trial with a parallel group design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PROF. DR.

Study Record Dates

First Submitted

April 5, 2025

First Posted

April 20, 2025

Study Start

November 5, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations