- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551180
Mandala Activity for Anxiety and Emotional and Psychological Well-Being in Adolescents With Siblings With Special Needs
Effect of a Mandala Activity on Anxiety Levels and Emotional and Psychological Well-Being in Adolescents Who Have Siblings With Special Needs: A Randomized Controlled Trial
The purpose of this randomized controlled trial is to evaluate whether a structured mandala activity program can reduce anxiety and improve emotional and psychological well-being in adolescents who have a sibling with special needs. Adolescents in this group may experience emotional difficulties because of the demands and challenges associated with having a sibling who requires special care and support. However, supportive and accessible interventions for these adolescents are limited.
In this study, eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a structured mandala activity program, while the control group will not receive this program during the study period. Anxiety and emotional and psychological well-being will be assessed before and after the intervention using standardized measurement tools.
The main question of this study is whether participation in the mandala activity program leads to better mental well-being outcomes compared with the control group. The findings may help determine whether mandala-based activities can be used as a simple, supportive, and non-pharmacological approach for adolescents who have a sibling with special needs.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial is designed to investigate the effect of a structured mandala activity program on anxiety and emotional and psychological well-being in adolescents who have a sibling with special needs. Adolescents in this group may be affected by psychosocial challenges associated with living with and supporting a sibling who requires ongoing special care. These challenges may influence their emotional adjustment and psychological well-being. However, evidence-based supportive interventions specifically targeting this population remain limited.
The primary objective of the study is to evaluate whether participation in a structured mandala activity program reduces anxiety and improves emotional and psychological well-being in adolescents who have a sibling with special needs. The study also aims to generate evidence regarding the potential usefulness of a structured, supportive, and non-pharmacological intervention for this population.
Participants who meet the eligibility criteria will be randomly allocated to either the intervention group or the control group. The intervention group will participate in the mandala activity program delivered in a structured format. The control group will not receive the mandala intervention during the study period and will continue under usual conditions. Assessments will be conducted before and after the intervention using standardized measurement tools evaluating anxiety and emotional and psychological well-being.
This study is based on the assumption that structured mandala activities may provide emotional expression, psychological support, and a calming effect for adolescents who experience stress related to having a sibling with special needs. The results of the study are expected to contribute to the literature on adolescent mental health and to support the development of feasible and accessible psychosocial interventions for this potentially vulnerable group.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Süleyman Şahin, MSc
- Phone Number: +90 542 429 3644
- Email: sahinsuleyman44@gmail.com
Study Contact Backup
- Name: Selma Öncel, PhD
- Phone Number: +90 533 764 01 97
- Email: oselma@akdeniz.edu.tr
Study Locations
-
-
Kars
-
Kars, Kars, Turkey (Türkiye), 36000
- Özel Kars Derman Özel Eğitim Ve Rehabilitasyon Merkezi
-
Contact:
- Selma Öncel, PhD
- Phone Number: +90 533 764 01 97
- Email: oselma@akdeniz.edu.tr
-
Contact:
- Süleyman Şahin, MSc
- Phone Number: +90 542 429 36 44
- Email: sahinsuleyman44@gmail.com
-
Principal Investigator:
- Süleyman Şahin, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents within the predefined study age range
- Having a sibling with special needs
- Ability to communicate in Turkish
- Willingness to participate in the study
- Written informed consent from a parent or legal guardian and assent from the adolescent
- Availability to attend the planned intervention and assessment sessions
Exclusion Criteria:
- Having any physical, cognitive, or communication problem that would prevent participation in the mandala activity program or completion of the measurement tools
- Not attending the planned intervention sessions
- Withdrawal of consent/assent during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in this arm will receive a structured mandala activity program.
The intervention is designed as a supportive behavioral program to reduce anxiety and improve emotional and psychological well-being.
Assessments will be conducted before and after the intervention period.
|
A structured mandala activity program administered to adolescents who have a sibling with special needs.
This behavioral intervention is designed to provide emotional support, promote self-expression, reduce anxiety, and improve emotional and psychological well-being.
The program will be delivered according to the planned study protocol for participants assigned to the intervention group.
|
|
No Intervention: Control Group
Participants in this arm will not receive the mandala activity program during the study period.
They will continue under usual conditions and will complete the same assessments as the intervention group at the planned measurement times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Level
Time Frame: Baseline and immediately after completion of the intervention
|
Change in anxiety level measured using the State-Trait Anxiety Inventory for Children.
|
Baseline and immediately after completion of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Well-Being
Time Frame: Baseline and immediately after completion of the intervention
|
Change in emotional well-being measured using the Stirling Children's Emotional and Psychological Well-Being Scale.
|
Baseline and immediately after completion of the intervention
|
|
Psychological Well-Being
Time Frame: Baseline and immediately after completion of the intervention
|
Change in psychological well-being measured using the Stirling Children's Emotional and Psychological Well-Being Scale.
|
Baseline and immediately after completion of the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Selma Öncel, PhD, Akdeniz University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBAEK-99
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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