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JASPER + PROMPT Interventions for Autism (BLOOM Trial)
N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 48-66 months
age 48-66 months
Must not have
Children who are deaf, blind or with cerebral palsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up t1 entry (1st month of study) and t2 exit (3 months after entry)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether adding a motor-sound system intervention to an evidence based joint attention intervention will improve speech and language outcomes for children with ASD.
Who is the study for?
The BLOOM trial is for children aged 48-66 months with Autism Spectrum Disorder who are minimally verbal, using less than 20 functional words. They must have walked by 24 months, have a nonverbal mental age over 12 months, and been in early intervention or preschool for at least three months. Children with severe disabilities like deafness, blindness, cerebral palsy or certain genetic disorders associated with ASD are not eligible.
What is being tested?
This study tests the effectiveness of combining two interventions: JASPER (a play-based therapy) and PROMPT (a speech-based therapy), versus just JASPER alone on improving language skills in autistic children. Over one year, changes will be tracked to see if these therapies help kids progress from single words to word combinations before Kindergarten.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, there may be variations in individual responses to the therapies which can include increased frustration or fatigue during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 4 and 5 years old.
Select...
My child is between 4 and 5 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child is deaf, blind, or has cerebral palsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in spontaneous socially communicative utterances (SCU) using the Elicitation of Language Samples for Analysis (ELSA).
Secondary study objectives
Change in number of novel and distinct word root (NDWR) based on the Preschool Language Scales-5 (PLS-5).
Change in number of novel and distinct word root (NDWR), and presence of word combinations at age six based on the ELSA language sample.
Presence of word combinations at age six based on the Preschool Language Scales-5 (PLS-5)
Other study objectives
Aberrant Behavior Checklist-2 (ABC-2)
Autism Diagnostic Interview-Revised (ADI-R)
Brief Observation of Social Communication Change (BOSCC)
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: JASPER onlyExperimental Treatment1 Intervention
This group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week.
Group II: JASPER + PROMPTActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JASPER
2018
N/A
~80
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,679 Total Patients Enrolled
21 Trials studying Autism Spectrum Disorder
2,441 Patients Enrolled for Autism Spectrum Disorder
University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,109 Total Patients Enrolled
25 Trials studying Autism Spectrum Disorder
4,319 Patients Enrolled for Autism Spectrum Disorder
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 4 and 5 years old.My child has been in early intervention or preschool for over 3 months.My child has been in early intervention or preschool for over 3 months.My child is deaf, blind, or has cerebral palsy.We will count how many words you say during a conversation. We want you to use simple words that you come up with on your own. This helps us understand how well you can talk.My child is not currently enrolled in another intervention trial.My child has a genetic disorder linked to autism, like TSC.I started walking before I was 2 years old.My medication has not changed in the last 6 months.I started walking before I was 2 years old.My child is between 4 and 5 years old.
Research Study Groups:
This trial has the following groups:- Group 1: JASPER + PROMPT
- Group 2: JASPER only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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