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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the JASPER and PROMPT treatments for autism?

Research shows that JASPER, which focuses on joint attention and symbolic play, can improve language skills and play diversity in children with autism. Studies found that children receiving JASPER showed greater expressive language gains and improved joint attention quality compared to control groups. ^{1 2 3 4 5}

Is the JASPER + PROMPT intervention safe for humans?

The available research on JASPER interventions, which focus on joint attention and play skills in children with autism, does not report any safety concerns. These interventions are generally considered safe as they involve educational and play-based activities. ^{3 5 6 7 8}

How is the JASPER treatment for autism different from other treatments?

JASPER is unique because it focuses specifically on improving joint attention (the ability to share focus on an object or event with another person) and symbolic play (using objects to represent other things) in young children with autism, which are areas often overlooked in other treatments. This approach has shown significant improvements in language development and social interactions compared to control groups. ^{1 2 4 5 9}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Language outcome in autism: randomized comparison of joint attention and play interventions. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Preschool based JASPER intervention in minimally verbal children with autism: pilot RCT. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Brief report: longitudinal improvements in the quality of joint attention in preschool children with autism. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. China pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of interactive group sandplay versus individual sandplay in the treatment of preschool children with autism spectrum disorder]. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Educators apply new teaching strategies despite initial attributions of autistic students' controllability of their behaviors. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Symbolic play in autism: a review. [2019]

9. United States 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. [2022]