- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07800026
Effectiveness of Dance Therapy for Students With Mild Autism Spectrum Disorder in China
Effectiveness of Dance Therapy for Social Play, Emotional Regulation, Group and Communication Skills of Students With Mild Autism in China: A Cluster Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yanmeng He, Master of Arts
- Telefonní číslo: +86 13453726056
- E-mail: gs66357@student.upm.edu.my
Studijní místa
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Shanxi
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Linfen, Shanxi, Čína, 041000
- Linfen Changxiang Children's Education Center
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Kontakt:
- Yuanfang Li
- Telefonní číslo: +86 13191119735
- E-mail: 176197012@qq.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged between 8 and 13 years.
- Have a pre-existing clinical diagnosis of mild Autism Spectrum Disorder (ASD), as documented in school or medical records.
- Have no other serious physical health issues, such as severe chronic diseases, major surgical history, or health problems that affect quality of life.
- Have no prior experience with dance therapy.
- Written informed consent is provided by the participant's parent or legal guardian.
Exclusion Criteria:
- Children with serious physical health conditions that may affect their ability to participate in the study.
- Children with prior experience in dance therapy.
- Children whose parent or legal guardian does not provide written informed consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Dance Movement Therapy (DMT) Group
Participants in this group will receive a 12-week Dance Movement Therapy (DMT) intervention, conducted twice weekly, with each session lasting 45 minutes during regular art class time.
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The Dance Movement Therapy (DMT) intervention will be delivered over 12 weeks, with two 45-minute sessions per week. Each session will include a warm-up phase, a core activity phase, and a closing phase, with additional time used flexibly for transitions and emotional adjustment. The intervention will use structured and creative movement activities, including mirror exercises, rhythm synchronization, spatial exploration, improvisational movement, symbolic movement, role-playing, cooperative activities, and relaxation exercises. The intervention will progress through three phases. Weeks 1-4 will focus on bodily awareness and spatial perception; Weeks 5-8 will focus on emotional expression, emotional regulation, social interaction, and cooperation; and Weeks 9-12 will focus on confidence, creativity, complex emotional understanding, and integration of previously developed skills. Activities will be adjusted to participants' responses and individual needs. |
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Aktivní komparátor: Regular Art Class (RAC) Group
Participants in this group will participate in Regular Art Class (RAC) activities for 12 weeks, conducted twice weekly, with each session lasting 45 minutes during regular art class time.
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The Regular Art Class (RAC) intervention will be delivered over 12 weeks, with two 45-minute sessions per week, following the school's conventional art curriculum. The program will include one Music and Rhythmic Movement session and one Art and Craft session per week. Sessions will consist of structured, teacher-guided activities and will typically include warm-up activities, theme-based learning, creative practice, and summary sharing, with additional time reserved for transitions and students' emotional needs. Music and Rhythmic Movement sessions will include singing, rhythm practice, simple body movements, group games, and cooperative activities. Art and Craft sessions will primarily include handicraft and collage activities during the first eight weeks, followed by painting activities from Week 9 onward. The activities will focus on creative expression, basic artistic skills, classroom participation, rhythmic abilities, fine motor skills, imagination, observation, color expression |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Social Play Assessed by the Penn Interactive Peer Play Scale (PIPPS)
Časové okno: Baseline and immediately after the 12-week intervention
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Social play will be assessed using the Penn Interactive Peer Play Scale (PIPPS), a 32-item teacher-rated measure of peer play behaviors.
The PIPPS assesses three dimensions: Play Interaction, Play Disruption, and Play Disconnection.
Items are rated on a four-point Likert scale (never, seldom, often, and always).
Higher Play Interaction scores indicate more positive peer play interactions, whereas higher Play Disruption and Play Disconnection scores indicate greater disruptive behavior and disengagement from peer play, respectively.
Scores will be calculated according to the established PIPPS scoring procedures.
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Baseline and immediately after the 12-week intervention
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Change in Emotional Regulation Assessed by the Chinese Version of the Emotion Regulation Checklist (ERC-C)
Časové okno: Baseline and immediately after the 12-week intervention
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Emotional regulation will be assessed using the Chinese Version of the Emotion Regulation Checklist (ERC-C), a 24-item rating scale completed by a parent, teacher, or other adult familiar with the child.
The ERC-C assesses two dimensions: Emotion Regulation and Lability/Negativity. Items are rated on a 7-point Likert scale from 1 (completely untrue) to 7 (completely true).
Emotion Regulation reflects adaptive emotional regulation, whereas Lability/Negativity reflects emotional reactivity and dysregulation.
Scores will be calculated according to the established scoring procedures.
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Baseline and immediately after the 12-week intervention
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Change in Group Skills Assessed by the Social Skills Subscale of the Chinese Version of the School Social Behavior Scales (SSBS-C)
Časové okno: Baseline and immediately after the 12-week intervention
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Group skills will be assessed using the 32-item Social Skills subscale of the Chinese Version of the School Social Behavior Scales (SSBS-C), completed by teachers or other school staff familiar with the child.
The subscale assesses three dimensions: Interpersonal Skills, Self-Management Skills, and Academic Skills.
Items are rated on a 5-point scale from 1 (never occurs) to 5 (always occurs).
Higher scores indicate stronger social skills, including interpersonal interaction, self-management, and skills relevant to effective participation and functioning in group settings.
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Baseline and immediately after the 12-week intervention
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Change in Communication Skills Assessed by the Chinese Version of the Communication Matrix (CM-C)
Časové okno: Baseline and immediately after the 12-week intervention
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Communication skills will be assessed using the Chinese Version of the Communication Matrix (CM-C), a functional communication assessment for individuals with limited verbal or spoken communication.
The assessment evaluates communication across seven developmental levels, ranging from pre-intentional behavior to abstract symbolic communication, and includes multiple forms of communication such as gestures, facial expressions, vocalizations, pictures, and other augmentative and alternative communication methods.
For quantifying change, individual communication behaviors are scored as 0 (not used), 1 (emerging), or 2 (mastered).
The total score ranges from 0 to 160, with higher scores indicating more developed functional communication skills.
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Baseline and immediately after the 12-week intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UPM-EDU-DMT-2026-001
- JKEUPM-2025-725 (Jiný identifikátor: Universiti Putra Malaysia Ethics Committee for Research Involving Human Subjects (JKEUPM))
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