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Набор скоро начнётся NCT07551180

Mandala Activity for Anxiety and Emotional and Psychological Well-Being in Adolescents With Siblings With Special Needs

Без фазы С лечением Anxiety Emotional Well-being Psychological Well-being

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mandala Activity Program.
Кому может быть актуально
Состояния в реестре: Anxiety, Emotional Well-being, Psychological Well-being. Базовые параметры: 10 лет — 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Mandala Activity Program
    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.

Первичные конечные точки

  • Anxiety Level [Срок оценки: Baseline and immediately after completion of the intervention]
Вторичные конечные точки (2)
  • Emotional Well-Being [Срок оценки: Baseline and immediately after completion of the intervention]
  • Psychological Well-Being [Срок оценки: Baseline and immediately after completion of the intervention]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Özel Kars Derman Özel Eğitim Ve Rehabilitasyon Merkezi — Kars

Идентификаторы

NCT: NCT07551180 · TBAEK-99

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗