- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yanmeng He, Master of Arts
- Número de telefone: +86 13453726056
- E-mail: gs66357@student.upm.edu.my
Locais de estudo
-
-
Shanxi
-
Linfen, Shanxi, China, 041000
- Linfen Changxiang Children's Education Center
-
Contato:
- Yuanfang Li
- Número de telefone: +86 13191119735
- E-mail: 176197012@qq.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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. |
|
Comparador Ativo: 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.
|
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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Social Play Assessed by the Penn Interactive Peer Play Scale (PIPPS)
Prazo: Baseline and immediately after the 12-week intervention
|
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.
|
Baseline and immediately after the 12-week intervention
|
|
Change in Emotional Regulation Assessed by the Chinese Version of the Emotion Regulation Checklist (ERC-C)
Prazo: Baseline and immediately after the 12-week intervention
|
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.
|
Baseline and immediately after the 12-week intervention
|
|
Change in Group Skills Assessed by the Social Skills Subscale of the Chinese Version of the School Social Behavior Scales (SSBS-C)
Prazo: Baseline and immediately after the 12-week intervention
|
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.
|
Baseline and immediately after the 12-week intervention
|
|
Change in Communication Skills Assessed by the Chinese Version of the Communication Matrix (CM-C)
Prazo: Baseline and immediately after the 12-week intervention
|
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.
|
Baseline and immediately after the 12-week intervention
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UPM-EDU-DMT-2026-001
- JKEUPM-2025-725 (Outro identificador: Universiti Putra Malaysia Ethics Committee for Research Involving Human Subjects (JKEUPM))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .