AnxietyNCT07551180
Mandala Activity for Anxiety and Emotional and Psychological Well-Being in Adolescents With Siblings With Special Needs
A study testing Mandala Activity Program in people with Anxiety and Emotional Well-being, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Emotional Well-being, Psychological Well-being
- What is being tested?
- Mandala Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Özel Kars Derman Özel Eğitim Ve Rehabilitasyon Merkezi
Kars, Kars, 36000
Süleyman Şahin, MSc, +90 542 429 36 44, sahinsuleyman44@gmail.com
Selma Öncel, PhD, +90 533 764 01 97, oselma@akdeniz.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Emotional Well-being, Psychological Well-being
- Being tested
- Mandala Activity Program
- Keywords
- Adolescents, Siblings with Special Needs, Mandala Activity, Emotional Well-Being, Psychological Well-Being, Anxiety, Randomized Controlled Trial
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala Activity ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Mandala Activity Program |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level
Change in anxiety level measured using the State-Trait Anxiety Inventory for Children.
Measured: Baseline and immediately after completion of the intervention
Secondary outcomes (2)
Emotional Well-Being
Change in emotional well-being measured using the Stirling Children's Emotional and Psychological Well-Being Scale.
Measured: Baseline and immediately after completion of the intervention
Psychological Well-Being
Change in psychological well-being measured using the Stirling Children's Emotional and Psychological Well-Being Scale.
Measured: Baseline and immediately after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start2 May 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either a structured mandala activity program group or a control group with no mandala intervention during the study period. Both groups will be followed in parallel and assessed before and after the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Selma Öncel, PhD, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551180
- Sponsor's protocol ID
- TBAEK-99
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of privacy, confidentiality, and ethical considerations related to the study population.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07551180
- Acronym / sponsor ID
- TBAEK-99
- Conditions
- Anxiety, Emotional Well-being, Psychological Well-being
- Keywords
- Adolescents, Siblings with Special Needs, Mandala Activity, Emotional Well-Being, Psychological Well-Being, Anxiety, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 2 May 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Apr 2026 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either a structured mandala activity program group or a control group with no mandala intervention during the study period. Both groups will be followed in parallel and assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mandala Activity ProgramParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Mandala Activity ProgramA 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. | Behavioural | Intervention Group |
Primary outcome
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.
2 secondary outcomes
Emotional Well-Being
Time frame: Baseline and immediately after completion of the intervention
Psychological Well-Being
Time frame: Baseline and immediately after completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of privacy, confidentiality, and ethical considerations related to the study population.
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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.
Selma Öncel, PhD principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Activity Program in people with Anxiety and Emotional Well-being, run by Akdeniz 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Süleyman Şahin, MSc (+90 542 429 3644, sahinsuleyman44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: Baseline and immediately after completion of the intervention). 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 24 Apr 2026.