NCT04218331: BLOOM

Boosting Language Outcomes of Minimally Verbal Children With ASD (BLOOM)

Active, enrolled NA Last updated 28 January 2026

What this trial tests

NA trial testing JASPER in Autism Spectrum Disorder in 56 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 April 2021

Primary endpoint
15 April 2026

31 August 2026

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	29 April 2021
Primary completion	15 April 2026
Estimated completion	31 August 2026
Sites	2 locations across United States

Drugs / interventions tested

• JASPER
• PROMPT

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

University of California, Los Angeles

Who can join

Adults 42 Months to 66 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Overcoming hurdles to intervention studies with autistic children with profound communication difficulties and their families.
   McKinney A, Weisblatt EJ, Hotson KL, Bilal Ahmed Z, et al · · 2021 · cited 16× · PMID 33827289 · DOI 10.1177/1362361321998916