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Tratamiento de comunicación social implementado por los padres en niños en edad preescolar con trastorno del espectro autista

30 de octubre de 2026 actualizado por: Patrick C. M. Wong, Chinese University of Hong Kong

Un enfoque de predicción a prescripción para el tratamiento de la comunicación social en niños en edad preescolar chinos con trastorno del espectro autista

An accumulation of research evidence has pointed to parent-implemented communication intervention as effective in reducing the severity of social communication deficits in autistic preschoolers. Despite even high-quality evidence, real-world translation to clinical practice remains challenging, especially for children from lower-income families, for two reasons. First, the intervention outcome is highly variable despite study-level efficacy data, most likely due to unique child and parent factors that make intervention response uneven across individual children. Second, the cost of intervention with the largest effect sizes remains high due to its one-on-one format. With the overarching goal to reduce cost and to increase intervention effectiveness at the individual-child level, this project will conduct a randomized controlled trial (RCT) to compare the effectiveness of two options for intervention to address two specific objectives. The investigators will first ascertain whether parent-implemented communication intervention taught by a speech therapist in a Group format (up to 8 families learning together) is more effective than intervention learnt by the parents themselves (learning the same materials without the guidance of a therapist) at the study level. The investigators will then evaluate what combinations of parent and child behavioral factors determine which format of intervention is likely to be more effective at the individual-child level. It is likely that not all families require the more costly Group format of intervention. Machine learning analytics with cross-validation will be used in constructing predictive models of intervention response, which will increase the likelihood of these models being generalizable to new patients.

This study will be among the first examples of fulfilling the promise of Precision Medicine in providing guidance to patients and families with developmental disorders not about whether to receive intervention but which option for intervention to receive in the context of multiple options. This predict-to prescribe approach of autism intervention will likely lead to a paradigm shift in clinical practice and ultimately result in lowering the overall cost and increasing the effectiveness of intervention for autistic children as individuals.

Descripción general del estudio

Descripción detallada

For parents of autistic children, the primary concern is to minimize the impact of the condition, likely through evidence-based intervention. The secondary concern is whether any intervention prescribed is affordable and the logistics of completion feasible. This project will obtain evidence for autism intervention options that have different costs and intervention delivery formats (group vs. self-study) to evaluate whether a more costly option is more effective at the study level. The investigators will then develop a predict to-prescribe approach that informs parents which intervention option would likely be most cost-effective in light of each family's unique characteristics (i.e., effectiveness at the individual-child level). [We use the term "parents" to mean caregivers throughout this protocol.]

Autism affects 14 per 10,000 (0.14%) children in Hong Kong and 39.23 per 10,000 in Mainland China. Social communication is a challenging domain in autism, and about 29% of autistic preschoolers have severe verbal deficits. Intervention through pharmaceutical means remains elusive, leaving behavioral interventions the most realistic and immediate avenue of intervention. This project will focus on enhancing the cost-effectiveness of behavioral intervention that targets language and communication. The investigators will do so in the context of precision medicine, in which the investigators aim to identify the most cost effective intervention for the individual autistic child.

AIM OF STUDY:

Objective 1: The investigators will first ascertain whether parent-implemented communication intervention taught by a speech therapist in a Group format (up to 8 families learning together) is more effective than intervention learnt by the parents themselves (learning the same materials without the guidance of a therapist) at the study level.

Objective 2: The investigators will examine pre-intervention child and parent variables simultaneously and construct predictive models of response to the two intervention options (group, more costly vs. self-study, less costly) at the individual-child level.

Tipo de estudio

Intervencionista

Inscripción (Actual)

112

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Shatin
      • Hong Kong, Shatin, Hong Kong
        • The Chinese University of Hong Kong
    • Guangdong
      • Shenzhen, Guangdong, Porcelana, 518057
        • Shenzhen Research Institute, The Chinese University of Hong Kong

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

2 años a 5 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Have a confirmed diagnosis of autism spectrum disorder or was evaluated to have elevated likelihood ("at-risk" or "suspected") by a Clinical Psychologist, Psychiatrist or Pediatrician who recommended continuous surveillance.
  • Meet ADOS-2 criteria for autism or autism spectrum.
  • Limited spontaneous expressive language, defined as producing two-to-three-word phrases or fewer, i.e., Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) Module 2, Item A1 > 0.

Exclusion Criteria:

  • Mullen Scale of Early Learning non-verbal age at or less than 12 months
  • Parent who has severe psychological or neurological conditions prohibiting them from conducting the intervention program at home (restricted to only the parent in the program)
  • Children with any other severe developmental problems beyond autism spectrum disorder

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group-based Parent-implemented Social Communication Training

Eight parents learning in a group format and will be taught by a speech therapist online.

The intervention will be taught by a speech therapist online (approximately 25 hours distributed over 6 months), with up to 8 parents in a group.

Comparador activo: Self-learning-based Parent-implemented Social Communication Training

Parents will learn the same materials without the guidance of a therapist.

Self-learning families will learn the same materials without the guidance of a therapist.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Autism severity change between baseline and 12 months
Periodo de tiempo: Baseline and 12 months after baseline

Comparing the pre- and post-intervention autism severity measured by comparison scores of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2) between groups.

The ADOS-2 CSS ranges from 0 to 10; the higher the scores, the more severe the autism symptoms.

Baseline and 12 months after baseline
Social skill changes
Periodo de tiempo: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline

Comparing the pre- and post-intervention social skills measured by the Social Affect score of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2), Social Communication Scale (SCS), and Vineland-3 between groups.

Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Expressive langauge changes
Periodo de tiempo: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline

Comparing the pre- and post-intervention expressive language skills measured by the Mullen Scales of Early Learning (MSEL), the MLU transcribed from the Social Communication Scale (SCS), and Vineland-3 between groups.

Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Receptive language changes
Periodo de tiempo: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline

Comparing the pre- and post-intervention receptive language skills measured by the Mullen Scales of Early Learning (MSEL), and Vineland-3 between groups.

Baseline, immediately post-intervention (at 6 months), and 12 months after baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Parental stress changes
Periodo de tiempo: Baseline and immediately post-intervention (at 6 months)

Comparing the pre- and post-intervention parental stress measured by the the Parental Stress Scale (PSS) between groups.

Baseline and immediately post-intervention (at 6 months)
Parental competence changes
Periodo de tiempo: Baseline and immediately post-intervention (at 6 months)

Comparing the pre- and post-intervention parental competence including self-efficacy and satisfaction measured by the Parenting Sense of Competence (PSOC) between groups.

Baseline and immediately post-intervention (at 6 months)
Parental strategy use changes
Periodo de tiempo: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline

Comparing the pre- and post-intervention parental strategy use including promoting engagement, encouraging communication, and direct teaching coded from the Social Communication Scale (SCS) between groups.

Baseline, immediately post-intervention (at 6 months), and 12 months after baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Patrick CM Wong, PhD, Chinese University of Hong Kong

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2022

Finalización primaria (Actual)

30 de noviembre de 2024

Finalización del estudio (Actual)

30 de diciembre de 2025

Fechas de registro del estudio

Enviado por primera vez

23 de noviembre de 2022

Primero enviado que cumplió con los criterios de control de calidad

23 de noviembre de 2022

Publicado por primera vez (Actual)

2 de diciembre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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