NCT06115343

Brief Summary

The aim of this study is to reveal the effect of mindfulness on self-efficacy and risky behaviors in adolescents.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

October 29, 2023

Last Update Submit

October 29, 2023

Conditions

Keywords

Conscious AwarenessSelf-Efficacyadolescent

Outcome Measures

Primary Outcomes (2)

  • Change in The Effect of Mindfulness Training on Self-Efficacy in Adolescents.

    Mindfulness-Based Self-Efficacy Scale scores range from 22 to 110. 22 is the lowest possible score and 110 is the highest possible score. The scale consists of 22 items and 6 dimensions. A low score indicates that their conscious-awareness-based self-efficacy is weak.

    [Time Frame: up to 6 weeks]

  • Change in The Impact of The Functioning of Detention Education in Adolescents.

    Risk Behavior Scale scores range from 36 to 180. 36 is the lowest possible score and 180 is the highest possible score. The scale consists of 36 items and 6 dimensions. Getting a high score from the scale indicates the intensity of risky behavior.

    [Time Frame: up to 6 weeks]

Study Arms (2)

Experimental Group

EXPERIMENTAL

Conscious Awareness application consists of 6 recordings of 30 minutes for 6 weeks.

Behavioral: Mindfulness

Control Group

NO INTERVENTION

Participants in the control group engage in 6 sessions of 30-minute social activity for 6 weeks.

Interventions

MindfulnessBEHAVIORAL

Conscious awareness practice was carried out in 6 sessions. Various inventories are used depending on the nature of the session. For example, in the leaf theme, participants are asked to close their eyes and put their thoughts from the past on a leaf and drop them into running water.

Experimental Group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Be between the ages of 14 and 18
  • Agree to participate in the study
  • Being literate and speaking Turkish fluently
  • Have communication and understanding skills

You may not qualify if:

  • Having a physical health problem that may impair group cohesion and integrity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korkut Ata University

Osmaniye, Center, 80000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yunus Ömer ARIK, Teacher

    pskdan.yunusomerarik@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teacher

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 3, 2023

Study Start

September 18, 2023

Primary Completion

October 27, 2023

Study Completion

November 20, 2023

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations