NCT04218331Active, not recruiting
Boosting Language Outcomes of Minimally Verbal Children With ASD (BLOOM)
Predicting & Optimizing Language Outcomes in Minimally Verbal Children With Autism Spectrum Disorder: Boosting Language Outcomes of Minimally Verbal Children With ASD
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
In this project, the investigator will test the effect of augmenting an evidence based joint attention intervention (JASPER) with a motor-sound system intervention (PROMPT) compared to JASPER only on speech and language outcomes. The investigator will model change over a year to determine the percentage of children who cross the hurdle from single words to word combinations by Kindergarten. The proposed research will foster the understanding of the mechanisms underlying speech heterogeneity in ASD, thereby ultimately contributing to the development of more personalized, efficacious interventions. Upon qualification to the study (after entry assessments), the child will be randomized to receive JASPER alone (play-based intervention) or JASPER plus PROMPT (both play-based and speech-based interventions). The active intervention will last for 12 weeks, 60 minute sessions twice a week. There are assessments scheduled at entry (6.5 hours), end of study (exit-2.5 hours), 3 month follow up (2 hours), and when the child turns 6 years of age (2 hours). The total time commitment per participant is 37 hours.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 19 Nov 2019
- Start date
- 29 Apr 2021
- Primary completion date
- 12 Jun 2026
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Autism
- NCT number
- NCT04218331
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 29 Apr 2021 to the primary completion date, 12 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- We will exclude children who are deaf, blind or with cerebral palsy.
- We will exclude children in other intervention trials; in other words, we will not double enroll children into intervention trials.
Who the study is looking for
- Children meeting ADOS-2 and ADI-R criteria for ASD
- age 42-66 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).
Age in the registry: 42 months to 66 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Semel Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.