Autism Spectrum DisorderBLOOMNCT04218331
Boosting Language Outcomes of Minimally Verbal Children With ASD (BLOOM)
A study testing JASPER and PROMPT in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 66 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- JASPER and PROMPT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 66 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Semel Institute
Los Angeles, California, 90024
UCLA
Los Angeles, California, 90095-1406
About this study
Official title: Predicting & Optimizing Language Outcomes in Minimally Verbal Children With Autism Spectrum Disorder: Boosting Language Outcomes of Minimally Verbal Children With ASD
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.
Read the detailed description
Children will be recruited through local school districts and early intervention service providers, approximately 20 children per year for a total of 80 children. Parents interested in the study will call the lab and be screened. If children pass the screen, they will be invited to go to UCLA for a series of assessments. The process will take 2-3 days. The following assessments and data will be collected: ADOS-2, ADI-R, Mullen Scales of Early Learning (MSEL), Demographic \& Medical Questionnaires, Vineland-III Interview, ELSA Language Sample, PLS-5,SPA, Repetitive Behaviors RBS-R, SSP, ABC-2, ESCS, BOSCC, KSPT, EEG, and saliva sample. Eligibility for the study will then evaluated. Each child's clinical diagnosis of ASD will be validated by administration of the Autism Diagnostic Observation Schedule-2 (ADOS-2) and the Autism Diagnostic Interview-Revised (ADI-R) by a research-reliable lab staff. Children will participate in a language sample (eligible if < 20 words), and the Mullen Scales of Early Learning (MSEL) to evaluate nonverbal mental age (eligible if > 12 months).
After qualifying to the study, the screening data will be entered into Biostatistics and Epidemiology Data Analytics Center (BEDAC), secured website. Randomization will then occur. Children will be randomly assigned to one of two intervention options: JASPER + PROMPT versus JASPER only.
JASPER is a naturalistic, developmental, behavioral intervention (NDBI) that focuses on developing social communication and language skills in the context of a play based intervention.
Intervening on oral motor skills may improve speech. In Los Angeles, a fairly common community intervention delivered by certified speech language pathologists (SLP) is Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT). PROMPT has a growing evidence base among a number of clinical populations with language delays related to oral motor deficits (although not ASD).
- JASPER only: Child will receive 2, 60 minute sessions per week at UCLA. or
- JASPER + PROMPT: Child will receive 2, 60 minute sessions per week at Santa Monica's SSLP, Inc.
Recruitment, screening assessments, consents, and treatment will occur in this Santa Monica location for this group. All these procedures will be done by the UCLA staff, except the PROMPT treatment. PROMPT will be done by the SLPs in the Scheflen Speech-Language Pathology, Inc.
All assessments, consent forms, measures, recruitment material will be the same for both conditions.
Interventions will occur for 12 weeks, 3 months. After the 3 months, there will be exit assessments (ELSA Language Sample, PLS-5, ESCS, BOSCC and EEG). There will also be assessment follow up at 3-months post exit, and when the child turns 6 years of age. The following assessments will be done at these time points: ELSA Language Sample, ESCS, BOSCC, PLS-5 at 3 mo-FU and ELSA Language Sample, ESCS, BOSCC, PLS-5 when child turns 6.
- Conditions
- Autism Spectrum Disorder
- Being tested
- JASPER, PROMPT
- Keywords
- PROMPT, JASPER, speech, autism, ELSA-T
- Medical subject headings
- Autism Spectrum Disorder, Speech, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JASPERBehavioural
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.
PROMPTBehavioural
PROMPT is a multidimensional oral-motor approach to speech production disorders.
| Study group | Role | What they receive |
|---|---|---|
| JASPER only | Experimental | This group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week. Receives: 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. Receives: Behavioral: JASPER; Behavioral: PROMPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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).
A child will be classified verbal if he/she meets the PLS-5 expressive item benchmark for word combinations. Children who do not show word combinations on the Language Sample or PLS-5 will be considered minimally verbal for this analysis.The standard scores for the PLS-5 range from 50 to 150. The higher the score, the better the outcome.
Measured: 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)
A child will be classified verbal if he/she meets the PLS-5 expressive item benchmark for word combinations. Children who do not show word combinations on the Language Sample or PLS-5 will be considered minimally verbal for this analysis. The standard scores for the PLS-5 range from 50 to 150. The higher the score, the better the outcome.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start29 Apr 2021
- Primary completion12 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218331
- Sponsor's protocol ID
- 19-000806
- Acronym
- BLOOM
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2019
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting & Optimizing Language Outcomes in Minimally Verbal Children With Autism Spectrum Disorder: Boosting Language Outcomes of Minimally Verbal Children With ASD
- ClinicalTrials.gov ID
- NCT04218331
- Acronym / sponsor ID
- BLOOM / 19-000806
- Conditions
- Autism Spectrum Disorder
- Keywords
- PROMPT, JASPER, speech, autism, ELSA-T
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children will be recruited through local school districts and early intervention service providers, approximately 20 children per year for a total of 80 children. Parents interested in the study will call the lab and be screened. If children pass the screen, they will be invited to go to UCLA for a series of assessments. The process will take 2-3 days. The following assessments and data will be collected: ADOS-2, ADI-R, Mullen Scales of Early Learning (MSEL), Demographic \& Medical Questionnaires, Vineland-III Interview, ELSA Language Sample, PLS-5,SPA, Repetitive Behaviors RBS-R, SSP, ABC-2, ESCS, BOSCC, KSPT, EEG, and saliva sample. Eligibility for the study will then evaluated. Each child's clinical diagnosis of ASD will be validated by administration of the Autism Diagnostic Observation Schedule-2 (ADOS-2) and the Autism Diagnostic Interview-Revised (ADI-R) by a research-reliable lab staff. Children will participate in a language sample (eligible if < 20 words), and the Mullen Scales of Early Learning (MSEL) to evaluate nonverbal mental age (eligible if > 12 months).
After qualifying to the study, the screening data will be entered into Biostatistics and Epidemiology Data Analytics Center (BEDAC), secured website. Randomization will then occur. Children will be randomly assigned to one of two intervention options: JASPER + PROMPT versus JASPER only.
JASPER is a naturalistic, developmental, behavioral intervention (NDBI) that focuses on developing social communication and language skills in the context of a play based intervention.
Intervening on oral motor skills may improve speech. In Los Angeles, a fairly common community intervention delivered by certified speech language pathologists (SLP) is Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT). PROMPT has a growing evidence base among a number of clinical populations with language delays related to oral motor deficits (although not ASD).
- JASPER only: Child will receive 2, 60 minute sessions per week at UCLA. or
- JASPER + PROMPT: Child will receive 2, 60 minute sessions per week at Santa Monica's SSLP, Inc.
Recruitment, screening assessments, consents, and treatment will occur in this Santa Monica location for this group. All these procedures will be done by the UCLA staff, except the PROMPT treatment. PROMPT will be done by the SLPs in the Scheflen Speech-Language Pathology, Inc.
All assessments, consent forms, measures, recruitment material will be the same for both conditions.
Interventions will occur for 12 weeks, 3 months. After the 3 months, there will be exit assessments (ELSA Language Sample, PLS-5, ESCS, BOSCC and EEG). There will also be assessment follow up at 3-months post exit, and when the child turns 6 years of age. The following assessments will be done at these time points: ELSA Language Sample, ESCS, BOSCC, PLS-5 at 3 mo-FU and ELSA Language Sample, ESCS, BOSCC, PLS-5 when child turns 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JASPER only | Experimental | Behavioral: JASPERThis group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week. |
| JASPER + PROMPT | Active comparator | Behavioral: JASPER, Behavioral: PROMPTThis 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. |
Who may qualify
- Ages
- 42 to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JASPERJASPER 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. | Behavioural | JASPER + PROMPT, JASPER only |
| PROMPTPROMPT is a multidimensional oral-motor approach to speech production disorders. | Behavioural | JASPER + PROMPT |
Primary outcome
Change in spontaneous socially communicative utterances (SCU) using the Elicitation of Language Samples for Analysis (ELSA).
Time frame: 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
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.
3 secondary outcomes
Change in number of novel and distinct word root (NDWR), and presence of word combinations at age six based on the ELSA language sample.
Time frame: 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).
Time frame: 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)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JASPER and PROMPT in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spontaneous socially communicative utterances (SCU) using the Elicitation of Language Samples for Analysis (ELSA). (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.