Improving language skills in minimally verbal children with autism

Predicting & Optimizing Language Outcomes in Minimally Verbal Children With Autism Spectrum Disorder: Boosting Language Outcomes of Minimally Verbal Children With ASD

This study is testing if combining two different therapies can help young children with autism who have limited speech improve their language skills.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 48 Months to 66 Months
• Sex: All
• Sponsor: University of California, Los Angeles (other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT04218331 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate the effectiveness of combining a joint attention intervention (JASPER) with a motor-sound system intervention (PROMPT) to enhance speech and language outcomes in minimally verbal children with Autism Spectrum Disorder (ASD). Children aged 48-66 months who meet specific criteria will be randomized to receive either JASPER alone or JASPER plus PROMPT over a 12-week period, with assessments conducted before, after, and at a 3-month follow-up. The study will involve comprehensive evaluations, including diagnostic assessments and language samples, to determine the impact of the interventions on children's ability to use word combinations by Kindergarten. The findings aim to deepen the understanding of speech variability in ASD and inform more personalized interventions.

Who should consider this trial

Good fit: Ideal candidates are children aged 48-66 months with a clinical diagnosis of ASD who use fewer than 20 functional words and have a nonverbal mental age of over 12 months.

Not a fit: Children who are deaf, blind, or have cerebral palsy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve language development in minimally verbal children with autism, helping them achieve better communication skills.

How similar studies have performed: Previous studies have shown promise in using similar interventions for improving communication skills in children with ASD, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Children meeting ADOS-2 and ADI-R criteria for ASD
* age 48-66 months
* have had \> 3 months of early intervention/preschool (to ensure that children already have been exposed to some community interventions)
* walked prior to 24 months
* use \< 20 functional words (i.e., non-echoed, non-scripted). Number of functional spoken words will be totaled in a language sample assessment. The functional word criterion is based on a 2010 NIH workgroup definition of 'minimally verbal' in school-aged children. The same definition may also apply to younger children with limited language.
* stable medication over the past 6 months
* nonverbal mental age of \>12 months on the Mullen Scales of Early Learning (visual reception and fine motor subscales).

Exclusion Criteria:

* We will exclude children who are deaf, blind or with cerebral palsy.
* We will not exclude on the basis of known genetic disorder associated with ASD (ex: TSC), but expect few will actually participate, in part due to rarity of these disorders, and because for some there are other trials available at UCLA (ex: TSC).
* We will exclude children in other intervention trials; in other words, we will not double enroll children into intervention trials.

Where this trial is running

Los Angeles, California and 1 other locations

• UCLA Semel Institute — Los Angeles, California, United States (RECRUITING)
• UCLA — Los Angeles, California, United States (RECRUITING)

Study contacts

• Study coordinator: Connie Kasari, PhD

Conditions: Autism Spectrum Disorder, PROMPT, JASPER, speech, autism, ELSA-T