ACTIVE_NOT_RECRUITING

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

Conditions

Autism Spectrum Disorder PROMPT JASPER speech autism ELSA-T

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Predicting & Optimizing Language Outcomes in Minimally Verbal Children With Autism Spectrum Disorder: Boosting Language Outcomes of Minimally Verbal Children With ASD

Quick Facts

Study Start:2021-04-29

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04218331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:42 Months to 66 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Locations (Sites)

UCLA Semel Institute

Los Angeles, California, 90024

United States

UCLA

Los Angeles, California, 90095-1406

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-29

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2021-04-29

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

PROMPT
JASPER
speech
autism
ELSA-T

Additional Relevant MeSH Terms

Autism Spectrum Disorder