Risky BehaviorNCT06115343
Conscious Awareness Practice in Adolescents
A study testing Mindfulness in people with Risky Behavior, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to reveal the effect of mindfulness on self-efficacy and risky behaviors in adolescents. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Risky Behavior
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2023to 20 Nov 2023
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Having a physical health problem that may impair group cohesion and integrity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consciousness in Adolescents The Effect of Awareness Practice on Self-Efficacy and Risky Behaviors
The aim of this study is to reveal the effect of mindfulness on self-efficacy and risky behaviors in adolescents.
Read the detailed description
This randomized controlled experimental study was carried out between 18 September and 27 October at Istanbul Bağcılar Necmettin Erbakan Science High School with a total of 60 students (30 experimental group / 30 control group). Research data were collected from the Conscious Awareness-Based Self-Efficacy Scale-Revised (BFÖS-Y), Risky Behaviors Scale (RDS) and Personal Information Form. Ethics committee approval, written institutional permission and written permission from the participants were obtained for the research. In the first week, pre-tests were given to the experimental and control groups, and the experimental group was given 30 minutes of mindfulness training. Mindfulness training continued to be given to the experimental group for the next 5 weeks, and post-tests were given to the experimental and control groups in the last week.
- Conditions
- Risky Behavior
- Being tested
- Mindfulness
- Keywords
- Conscious Awareness, Self-Efficacy, adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Conscious Awareness application consists of 6 recordings of 30 minutes for 6 weeks. Receives: Behavioral: Mindfulness |
| Control Group | No intervention | Participants in the control group engage in 6 sessions of 30-minute social activity for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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.
Measured: [Time Frame: up to 6 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start18 Sep 2023
- Primary completion27 Oct 2023
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risky BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Omer Arık, Osmaniye Korkut Ata University
- Investigators
- Yunus Ömer ARIK, Teacher, Principal investigator, pskdan.yunusomerarik@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115343
- Sponsor's protocol ID
- MINDFULNESS PRACTICE
- Status last verified
- Oct 2023
- First submitted
- 29 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consciousness in Adolescents The Effect of Awareness Practice on Self-Efficacy and Risky Behaviors
- ClinicalTrials.gov ID
- NCT06115343
- Acronym / sponsor ID
- MINDFULNESS PRACTICE
- Conditions
- Risky Behavior
- Keywords
- Conscious Awareness, Self-Efficacy, adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to reveal the effect of mindfulness on self-efficacy and risky behaviors in adolescents.
Detailed description
This randomized controlled experimental study was carried out between 18 September and 27 October at Istanbul Bağcılar Necmettin Erbakan Science High School with a total of 60 students (30 experimental group / 30 control group). Research data were collected from the Conscious Awareness-Based Self-Efficacy Scale-Revised (BFÖS-Y), Risky Behaviors Scale (RDS) and Personal Information Form. Ethics committee approval, written institutional permission and written permission from the participants were obtained for the research. In the first week, pre-tests were given to the experimental and control groups, and the experimental group was given 30 minutes of mindfulness training. Mindfulness training continued to be given to the experimental group for the next 5 weeks, and post-tests were given to the experimental and control groups in the last week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: MindfulnessConscious Awareness application consists of 6 recordings of 30 minutes for 6 weeks. |
| Control Group | No intervention | –Participants in the control group engage in 6 sessions of 30-minute social activity for 6 weeks. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Having a physical health problem that may impair group cohesion and integrity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessConscious 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. | Behavioural | Experimental Group |
Primary outcome
Change in The Effect of Mindfulness Training on Self-Efficacy in Adolescents.
Time frame: [Time Frame: up to 6 weeks]
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.
Change in The Impact of The Functioning of Detention Education in Adolescents.
Time frame: [Time Frame: up to 6 weeks]
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunus Ömer ARIK, Teacher principal investigator
pskdan.yunusomerarik@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Risky Behavior, run by Osmaniye Korkut Ata University 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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?
Results are not available in the source record.
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?
Change in The Effect of Mindfulness Training on Self-Efficacy in Adolescents. (time frame: [Time Frame: up to 6 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 3 Nov 2023.