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Elternimplementierte soziale Kommunikationsbehandlung bei Vorschulkindern mit Autismus-Spektrum-Störung

30. Oktober 2026 aktualisiert von: Patrick C. M. Wong, Chinese University of Hong Kong

Ein Predict-to-Prescribe-Ansatz zur Behandlung der sozialen Kommunikation bei chinesischen Vorschulkindern mit Autismus-Spektrum-Störung

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

112

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Jahre bis 5 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.

Aktiver Komparator: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Autism severity change between baseline and 12 months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Parental stress changes
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2022

Primärer Abschluss (Tatsächlich)

30. November 2024

Studienabschluss (Tatsächlich)

30. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

23. November 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. November 2022

Zuerst gepostet (Tatsächlich)

2. Dezember 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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