JASPER + PROMPT Interventions for Autism

(BLOOM Trial)

Recruiting at 1 trial location

Overseen By Consuelo Garcia, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Deaf, Blind, Cerebral palsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 28

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how combining two therapies, JASPER (a play-based intervention) and PROMPT (a speech-based intervention), can help children with autism improve their speech and language skills. Researchers will compare these combined treatments to JASPER alone to determine which approach better supports children in forming word combinations by Kindergarten. Children who may benefit from this trial are those with autism who use fewer than 20 functional words and have had some early intervention or preschool experience. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their communication skills through innovative therapy combinations.

Will I have to stop taking my current medications?

The trial requires that participants have stable medication over the past 6 months, which suggests you should not change your current medications.

What prior data suggests that these interventions are safe for children with autism?

Research has shown that the JASPER intervention is generally safe for children with autism. Studies have found that children participating in JASPER sessions experienced significant improvements in communication and play skills without major side effects. As a play-based therapy, JASPER offers a gentle and well-tolerated approach for young children.

Specific safety information about combining JASPER with PROMPT is limited. However, PROMPT, a widely used speech therapy method, is usually considered safe. Both JASPER and PROMPT aim to enhance communication and social skills, which are crucial for children with autism.

Although the combined use of these therapies hasn't been widely studied, their individual application in similar contexts hasn't raised major safety concerns. This suggests that using them together is likely well-tolerated. Parents should consult healthcare providers about any concerns before enrolling their children in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the JASPER + PROMPT interventions for autism because they offer a unique approach by combining play-based therapy with speech therapy techniques. JASPER is distinctive because it focuses on enhancing social communication skills through structured play, which is different from many traditional methods that mainly emphasize behavioral changes. The addition of PROMPT, a tactile-kinesthetic approach that targets oral-motor skills, provides a comprehensive strategy for improving speech and communication. This combination addresses both social and verbal aspects, potentially offering a more holistic improvement for children with autism compared to standard therapies.

What evidence suggests that the JASPER and PROMPT interventions could be effective for improving speech and language outcomes in children with autism?

Research shows that the JASPER program, which participants in this trial may receive, can greatly improve social communication skills in children with autism. Studies have found that JASPER helps children focus on shared activities, play with imagination, and stay engaged during playtime, all of which are important for learning language.

In this trial, one group will receive JASPER combined with the PROMPT method, which improves speech through guided mouth and tongue movements. Although few studies have examined the combination of JASPER and PROMPT, the success of each method individually suggests they could work well together. Overall, these programs aim to help children progress from using single words to forming phrases, enhancing their communication skills over time. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

My child is deaf, blind, or has cerebral palsy.

My child is not currently enrolled in another intervention trial.

My child has a genetic disorder linked to autism, like TSC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 days

1 visit (in-person)

Treatment

Participants receive JASPER alone or JASPER plus PROMPT interventions, 60-minute sessions twice a week

12 weeks

24 visits (in-person)

Exit Assessment

Exit assessments including ELSA Language Sample, PLS-5, ESCS, BOSCC, and EEG

1 week

1 visit (in-person)

Follow-up

Participants are monitored for language outcomes at 3 months post-exit and when the child turns 6 years of age

Long-term

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• JASPER
• PROMPT

Trial Overview 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.

How Is the Trial Designed?

Group I: JASPER only Experimental Treatment 1 Intervention

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

Group II: JASPER + PROMPT Active Control 2 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.

JASPER is already approved in United States for the following indications:

Approved in United States as JASPER for:

• Autism Spectrum Disorder (ASD), specifically for improving social communication and play skills in minimally verbal children

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Preschoolers with autism who participated in joint attention and symbolic play interventions showed significant improvements in the quality of joint attention, specifically in shared positive affect and utterances, compared to a control group.

The study highlights the effectiveness of targeted interventions in enhancing joint attention quality in children with autism, suggesting that these approaches can foster better social interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: longitudinal improvements in the quality of joint attention in preschool children with autism. Lawton, K., Kasari, C.[2021]

In a study involving 58 preschool children with autism, both joint attention (JA) and symbolic play (SP) interventions led to greater expressive language gains compared to a control group after 5-6 weeks of daily sessions.

Children with the lowest initial language levels showed significantly better language outcomes from the JA intervention compared to the SP and control groups, highlighting the importance of targeting JA skills in early autism treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Language outcome in autism: randomized comparison of joint attention and play interventions. Kasari, C., Paparella, T., Freeman, S., et al.[2022]

A study involving 66 autistic preschool students and 12 educators found that educators' perceptions of their students' ability to control autism-related behaviors influenced their use of joint engagement strategies during play.

Despite initial perceptions, educators who received training in the JASPER intervention were able to effectively learn and implement new strategies to promote joint engagement, indicating that training can help overcome biases in educator behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educators apply new teaching strategies despite initial attributions of autistic students' controllability of their behaviors. Panganiban, J., Kasari, C.[2023]

A study involving 80 preschool children with autism spectrum disorder (ASD) found that interactive group sandplay significantly improved social withdrawal and overall behavior compared to individual sandplay after three months of treatment.

Both treatment methods were effective, but the interactive group sandplay led to greater improvements in sociability, emotional responses, and reductions in stereotypic behaviors, highlighting its potential as a more beneficial intervention for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of interactive group sandplay versus individual sandplay in the treatment of preschool children with autism spectrum disorder]. Wang, YX., Lu, GB., Ge, P., et al.[2020]

Research indicates that autistic children show significant impairments in spontaneous symbolic and functional play, suggesting a deficit in these areas.

However, studies that prompted or instructed play suggest that autistic children may have the ability to engage in symbolic play when guided, indicating that their capacity for such play might not be fully expressed spontaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symbolic play in autism: a review. Jarrold, C., Boucher, J., Smith, P.[2019]

In a pilot study involving minimally verbal children with autism aged 3 to 5, the JASPER intervention showed significant improvements in play diversity and engagement compared to a control group receiving standard ABA therapy.

The JASPER treatment, which included just 30 minutes of intervention twice a week, led to increased initiation of gestures and reduced unengaged time in the classroom, highlighting its potential effectiveness in addressing core deficits in autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preschool based JASPER intervention in minimally verbal children with autism: pilot RCT. Goods, KS., Ishijima, E., Chang, YC., et al.[2021]

Pivotal Response Training (PRT) effectively taught 7 children with autism to engage in symbolic play, resulting in all participants demonstrating complex and creative play behaviors comparable to typical peers.

The children not only generalized their newly learned play skills to different toys and settings but also maintained these behaviors three months after training, indicating lasting benefits and improved interaction skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching symbolic play skills to children with autism using pivotal response training. Stahmer, AC.[2019]

A study involving 58 children with autism aged 3 to 4 years showed that targeted interventions for joint attention and symbolic play significantly improved relevant behaviors compared to a control group.

Children receiving joint attention training initiated more joint attention behaviors, while those in the symbolic play group demonstrated greater diversity and higher levels of play, indicating the effectiveness of these interventions in enhancing developmental skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. Kasari, C., Freeman, S., Paparella, T.[2007]

A 9-week robot-based play-drama intervention significantly improved joint attention initiations and functional play behaviors in preschool children with autism spectrum disorder (ASD), with 12 children participating in the intervention group.

Parents reported less severe social impairments in their children after the intervention, suggesting that this approach can effectively enhance social skills in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Robot-Based Play-Drama Intervention May Improve the Joint Attention and Functional Play Behaviors of Chinese-Speaking Preschoolers with Autism Spectrum Disorder: A Pilot Study. So, WC., Cheng, CH., Lam, WY., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9879144/

JASPER early intervention for children with ASD - PMC Joint engagement mediates 69% of the effect of JASPER intervention on children's social communication skills and leads to gains in children's ...

2. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/13623613211019162

The effects of JASPER intervention for children with autism ... Most studies found that children who received JASPER intervention showed significantly greater improvements in at least one outcome.

3. ies.ed.gov ies.ed.gov/use-work/awards/efficacy-trial-j-emt-enhanced-milieu-teaching-language-intervention-plus-joint-attention-engagement

An Efficacy Trial of J-EMT: Enhanced Milieu Teaching ... This project will evaluate the efficacy of an early social communication and language intervention, the J-EMT, on toddlers with autism spectrum disorders (ASD).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34348479/

The effects of JASPER intervention for children with autism ... Most studies found that children who received JASPER intervention showed significantly greater improvements in at least one outcome.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0891422224001288

The JASPER (Joint Attention, Symbolic Play, Engagement ... Caregivers learned to implement JASPER strategies and pilot data suggest improvements in joint engagement and regulation during play. Case series data show ...

6. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-3-2021-d1c27

JASPER Intervention for Autism (EBJ Trial) This trial is testing JASPER, a play-based therapy, on young children with autism who have limited verbal skills. The therapy uses guided play to help these ...

7. pubs.asha.org pubs.asha.org/doi/10.1044/2021_PERSP-21-00222

Development and Usability Testing of a Web-Based ... The JASPER model for children with autism: Promoting joint attention, symbolic play, engagement, and regulation. Guilford. Go to Citation.

8. abagroup.org abagroup.org/jasper

Joint Attention, Symbolic Play and Engagement Regulation ... The objective for every JASPER session is to increase joint engagement, diversify and expand play skills, and promote nonverbal and verbal communication. First, ...