Active — Not RecruitingNot Applicable

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

United States56 participantsStarted 2021-04-29

Plain-language 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.

Who can participate

Age range42 Months – 66 Months

SexALL

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Inclusion Criteria: * 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). 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.

What they're measuring

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

Timeframe: 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

Trial details

NCT IDNCT04218331

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-15