NCT07551180

Brief 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. 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.

Trial Health

63
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Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress10%
May 2026Jun 2026

First Submitted

Initial submission to the registry

April 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

AdolescentsSiblings with Special NeedsMandala ActivityEmotional Well-BeingPsychological Well-BeingAnxietyRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Anxiety Level

    Change in anxiety level measured using the State-Trait Anxiety Inventory for Children.

    Baseline and immediately after completion of the intervention

Secondary Outcomes (2)

  • Emotional Well-Being

    Baseline and immediately after completion of the intervention

  • Psychological Well-Being

    Baseline and immediately after completion of the intervention

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özel Kars Derman Özel Eğitim Ve Rehabilitasyon Merkezi

Kars, Kars, 36000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Officials

  • Selma Öncel, PhD

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be masked to group allocation and will not be informed whether they are assigned to the intervention group or the control group. Due to the nature of the study procedures, the researchers conducting the intervention and follow-up assessments will be aware of group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 24, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because of privacy, confidentiality, and ethical considerations related to the study population.

Locations