Parent-implemented Social Communication Treatment in Autism

NCT05635760 | Active Not Recruiting

• 1 other identifier: CRFASD-SZ-22
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Autism; Social Communication; Speech Therapy; Parenting; Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Parent-implemented Intervention; Social Communication

Outcome Measures

Primary Outcomes (4)

• Autism severity change between baseline and 12 months

  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

  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

  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

  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

Secondary Outcomes (3)

• Parental stress changes

  Baseline and immediately post-intervention (at 6 months)

• Parental competence changes

  Baseline and immediately post-intervention (at 6 months)

• Parental strategy use changes

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

Study Arms (2)

Group-based Parent-implemented Social Communication Training

EXPERIMENTAL

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

Behavioral: Group-based Parent-implemented Social Communication Training

Self-learning-based Parent-implemented Social Communication Training

ACTIVE COMPARATOR

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

Behavioral: Self-learning-based Parent-implemented Social Communication Training

Interventions

Group-based Parent-implemented Social Communication Training BEHAVIORAL

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.

Group-based Parent-implemented Social Communication Training

Self-learning-based Parent-implemented Social Communication Training BEHAVIORAL

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

Self-learning-based Parent-implemented Social Communication Training

Eligibility Criteria

• Age: 24 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Shenzhen Research Institute, The Chinese University of Hong Kong

Shenzhen, Guangdong, 518057, China

Location

The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

Location

MeSH Terms

Conditions

Autistic Disorder; Communication; Communication Disorders; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick CM Wong, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stanley Ho Professor of Cognitive Neuroscience; Director of Brain and Mind Institute

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 2, 2022
• Study Start: October 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (1)