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

NCT04218331 | Active Not Recruiting DMC

• 1 other identifier: 19-000806
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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

Autism Spectrum Disorder

Keywords

PROMPT; JASPER; speech; autism; ELSA-T

Outcome Measures

Primary Outcomes (1)

• Change in spontaneous socially communicative utterances (SCU) using the Elicitation of Language Samples for Analysis (ELSA).

  The ELSA is comprised of a series of semi-structured activities including: play-based interactive activities centered around a nature walk (falling leaves; planting an acorn, finding animals; making and eating S'mores); conversational chat and clean up; crafts (art project); games (bean bag toss); and an optional video narration (Pixar short movies, presented to the participant on a tablet). The activities are appropriate for the age range of this study (4 to 7 years). The more words the child has, the better the outcome.

  T1 entry (1st month of study), T2 exit (3 months after entry), T3 3-month Follow Up (6 months after entry), T4 when child turns 6 years of age

Secondary Outcomes (3)

• Change in number of novel and distinct word root (NDWR), and presence of word combinations at age six based on the ELSA language sample.

  T1 entry (1st month of study), T2 exit (3 months after entry), T3 3-month Follow Up (6 months after entry), T4 when child turns 6 years of age

• Change in number of novel and distinct word root (NDWR) based on the Preschool Language Scales-5 (PLS-5).

  T1 entry (1st month of study), T2 exit (3 months after entry), T3 3-month Follow Up (6 months after entry), T4 when child turns 6 years of age

• Presence of word combinations at age six based on the Preschool Language Scales-5 (PLS-5)

  T1 entry (1st month of study), T2 exit (3 months after entry), T3 3-month Follow Up (6 months after entry), T4 when child turns 6 years of age

Other Outcomes (15)

• Brief Observation of Symptoms of Autism (BOSA)

  T1 entry (1st month of study)

• Mullen Scales of Early Learning (MSEL)

  T1 entry (1st month of study)

• Demographic and Medical Questionnaire

  T1 entry (1st month of study)

Study Arms (2)

JASPER only

EXPERIMENTAL

This group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week.

Behavioral: JASPER

JASPER + PROMPT

ACTIVE COMPARATOR

This group will consist of the child and therapist having one-on-one, JASPER sessions plus Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT), twice a week.

Behavioral: JASPER; Behavioral: PROMPT

Interventions

JASPER BEHAVIORAL

JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the clinician/therapist.

JASPER + PROMPT; JASPER only

PROMPT BEHAVIORAL

PROMPT is a multidimensional oral-motor approach to speech production disorders.

JASPER + PROMPT

Eligibility Criteria

• Age: 42 Months - 66 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

UCLA Semel Institute

Los Angeles, California, 90024, United States

Location

UCLA

Los Angeles, California, 90095-1406, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Speech; Autistic Disorder

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/PhD

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: January 6, 2020
• Study Start: April 29, 2021
• Primary Completion: April 15, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (2)