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NCT04218331 · ClinicalTrials.gov registry record · NA

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

A NA study of Autism Spectrum Disorder, sponsored by University of California, Los Angeles.

Active
Registry status
NA
Development phase
56
Enrollment target
2
Study locations

NCT04218331 is a NA study of Autism Spectrum Disorder that is active but no longer recruiting, run by University of California, Los Angeles. The registered enrollment target is 56 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (59% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT04218331, a NA study of Autism Spectrum Disorder, is active but no longer recruiting, sponsored by University of California, Los Angeles.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
56 participants
Enrollment target
2
Study locations

Study Summary

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.

Conditions Studied

Autism Spectrum Disorder

Interventions

  • BEHAVIORAL JASPER
  • BEHAVIORAL PROMPT

Study Locations (2)

California

  • UCLA Semel Institute - Los Angeles
  • UCLA - Los Angeles

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2021-04-29
Est. Completion 2026-08-31
Phase NA

Sponsor

University of California, Los Angeles

897 total trials

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What the Registry Record Tells You About NCT04218331

The ClinicalTrials.gov registry entry for NCT04218331 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (59% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which JASPER is the first listed.

NCT04218331 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04218331 about?

NCT04218331 is a clinical study titled "Boosting Language Outcomes of Minimally Verbal Children With ASD (BLOOM)". 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 percen...

What is the current status of trial NCT04218331?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 56 participants. The study started on 2021-04-29. Estimated completion is 2026-08-31.

What conditions does trial NCT04218331 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder.

What interventions are being tested in trial NCT04218331?

The interventions under investigation include: JASPER (BEHAVIORAL), PROMPT (BEHAVIORAL).

Who is sponsoring clinical trial NCT04218331?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04218331 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.