Parent-implemented Social Communication Treatment in Preschool Children With Autism Spectrum Disorder

NCT05455411 | Active Not Recruiting

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

Brief Summary

An accumulation of research evidence has pointed to parent-implemented communication treatment as effective in reducing the severity of social communication deficits in preschool children with ASD. 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 treatment outcome is highly variable despite study-level efficacy data, most likely due to unique child and parent factors that make treatment 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 treatment 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 treatment taught by a speech therapist in an Individual (one-on-one) format is more effective than treatment taught in a Group format (up to 8 families learning together) at the study level. The Individual format is at least 4 times more expensive than the Group format; its relative treatment effect must be empirically ascertained to justify its cost. The investigators will then evaluate what combinations of parent and child behavioral and neural 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 Individual format of intervention. Machine-learning analytics with cross-validation will be used in constructing predictive models of treatment 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 ASD 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 children with ASD as individuals.

Conditions

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

Keywords

Autism Spectrum Disorder; Parent-implemented Intervention; Social Communication

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Social Affect at 12 months

  Comparing the pre- and post-treatment social affect measured by the Social Affect subscore of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2) between groups. The Social Affect subscore of ADOS-2 ranges from 0 to 20; the higher ADOS-2 scores mean a worse outcome.

  Baseline and at 12 months after the beginning of treatment

Secondary Outcomes (5)

• Change from Baseline Number of Parent-child Turn-taking at 6 months and 12 months

  Baseline, at 6 months and at 12 months after the beginning of treatment

• Change from Baseline Mean Length of Utterance at 6 months and 12 months

  Baseline, at 6 months and at 12 months after the beginning of treatment

• Change from Baseline Number of Nouns and Verbs at 6 months and 12 months

  Baseline, at 6 months and at 12 months after the beginning of treatment

• Change from Baseline Prosody in terms of loudness variation at 6 months and 12 months

  Baseline, at 6 months and at 12 months after the beginning of treatment

• Change from Baseline Prosody in terms of fundamental frequency at 6 months and 12 months

  Baseline, at 6 months and at 12 months after the beginning of treatment

Study Arms (2)

Group-based Parent-implemented Social Communication Training

EXPERIMENTAL

A group-based parent-implemented social communication treatment program for up to 8 parents of children with autism spectrum disorder

Behavioral: Group-based Parent-implemented Training

Individual-based Parent-implemented Social Communication Training

ACTIVE COMPARATOR

An individual-based parent-implemented social communication treatment program for a parent of a child with autism spectrum disorder

Behavioral: Individual-based Parent-implemented Training

Interventions

Group-based Parent-implemented Training BEHAVIORAL

A group-based social communication training for parents of preschoolers with autism spectrum disorder 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

Individual-based Parent-implemented Training BEHAVIORAL

An individual-based social communication training for parents of preschoolers with autism spectrum disorder will be taught by a speech therapist online in a one-on-one format (approximately 25 hours distributed over 6 months).

Individual-based Parent-implemented Social Communication Training

Eligibility Criteria

• Age: 18 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.
• ADOS-2 score in the spectrum range (for Modules 1 \& 2) or mild-to-moderate concern range (for Toddler Module)

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 treatment 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)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

Castle Peak Hospital

Tuenmen, Hong Kong

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Communication; Communication Disorders

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 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: June 29, 2022
• First Posted: July 13, 2022
• Study Start: July 1, 2022
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)