Parent-implemented Social Communication Treatment in Autism

Condition(s) studied

Investigational drug(s) / intervention(s)

Group-based Parent-implemented Social Communication Training: 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.

Self-learning-based Parent-implemented Social Communication Training: Self-learning families will learn the same materials without the guidance of a therapist.

Study 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.

Eligibility

Primary outcome measure(s)

• Autism severity change between baseline and 12 months — 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.
• Social skill changes — 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.
• Expressive langauge changes — 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.
• Receptive language changes — 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.

Trial sites (2)

More Chinese University of Hong Kong trials in China

Other trials for the same condition