DTT + JASPER for Autism

Recruiting at 2 trial locations

Overseen By Consuelo Garcia, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Sensory impairments, Genetic syndromes, others

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

Compensation: Varies

Number of Visits: 4

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to improve language skills in preschool children with autism using a structured teaching and social interaction-based learning program. The program is adjusted based on each child's progress. The goal is to help these children develop better communication skills and avoid being minimally verbal by age 6.

Do I need to stop my current medications for the trial?

The trial requires that participants have stable medication for the past 6 months, so you should not change your current medications if you want to participate.

What data supports the effectiveness of the DTT + JASPER treatment for autism?

Research shows that JASPER, which is part of the DTT + JASPER treatment, helps improve play diversity and social interactions in children with autism. Additionally, Discrete Trial Training (DTT) has been effective in teaching language and play skills, suggesting that combining these approaches could be beneficial for children with autism. ^{1 2 3 4 5}

Is the DTT + JASPER treatment safe for humans?

The available studies on JASPER and related interventions like DTT (Discrete Trial Training) and ABA (Applied Behavior Analysis) do not report any safety concerns, suggesting these treatments are generally safe for use in children with autism. ^{2 3 5 6 7}

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

The DTT + JASPER treatment is unique because it combines Discrete Trial Training (DTT), which is a structured teaching method, with JASPER, which focuses on improving joint attention and symbolic play skills. This combination targets specific developmental areas that are often delayed in children with autism, such as social interaction and play, which are not always the primary focus of other treatments. ^{2 4 6 8 9}

Eligibility Criteria

The PRISM study is for preschoolers aged 36-59 months with Autism Spectrum Disorder who speak less than 20 functional words. They must have had over 3 months of early intervention, stable medication for the past half year, and a nonverbal mental age above one year. Children with sensory/motor impairments or genetic syndromes like Down Syndrome are not eligible.

Inclusion Criteria

My child has been diagnosed with autism.

I am between 3 and 5 years old.

You have certain changes in your genes that can be treated with medication.

Exclusion Criteria

I likely haven't been exposed to AAC.

I do not have sensory, motor impairments, or known genetic syndromes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive either JASPER or DTT intervention for 10 weeks, 2 hours per week

10 weeks

2 visits per week (in-person)

Stage 2 Treatment

Early responders continue with the same intervention; slow responders are re-randomized to either intensify the current intervention or switch to Combined & Enhanced Treatment (CET)

10 weeks

2-4 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 10 weeks post-treatment and at age 6

Long-term

Treatment Details

Interventions

• DTT
• JASPER

Trial Overview This trial tests an adaptive two-stage language development approach over 20 weeks for minimally verbal children with ASD in community settings. It aims to personalize treatment by choosing between DTT (Discrete Trial Training), JASPER, and CET interventions based on each child's needs.

Participant Groups

Group I: JASPER Active Control 1 Intervention

Child will spend 2 hours per week (2 days, 1 hour per day) for the first 10 weeks doing JASPER. If the child is an early responder, he/she will remain in the same course for the following 10 weeks. If child is a slow responder, he/she will be randomized for either combined \& enhanced treatment (CET) for 2 hours a week (2 days, 1 hour per day) or Intensified JASPER for 4 hours a week (4 days, 1 hour per day).

Group II: DTT Active Control 1 Intervention

Child will spend 2 hours per week (2 days, 1 hour per day) for the first 10 weeks doing DTT. If the child is an early responder, he/she will remain in the same course for the following 10 weeks. If child is a slow responder, he/she will be randomized for either combined \& enhanced treatment (CET) for 2 hours a week (2 days, 1 hour per day) or Intensified DTT for 4 hours a week (4 days, 1 hour per day).

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

Approved in United States as Discrete Trial Training for:

• Autism Spectrum Disorder
• Developmental Delays

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

In a study involving young children at risk for autism spectrum disorder, both discrete trial training and pivotal response training were effective in teaching language, play, and imitation skills over a 12-week period.

The effectiveness of each training method varied by child and skill domain, indicating that early learning rates could help predict long-term treatment success and guide personalized intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varied treatment response in young children with autism: A relative comparison of structured and naturalistic behavioral approaches. Jobin, A.[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]

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]

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 new automated gaming platform designed for children with autism focuses on improving key skills like Imitation and Joint Attention through engaging games, showing promise for intensive intervention in home settings.

In a 3-month trial with 10 children, parents reported improvements in their child's concentration (78%), flexibility (89%), and self-esteem (44%), indicating the platform's potential effectiveness in enhancing developmental skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. Bono, V., Narzisi, A., Jouen, AL., et al.[2020]

The GOLIAH gaming platform, used alongside traditional treatment for children with autism spectrum disorder (ASD), showed improvements in joint attention and imitation skills over a 6-month period, although it did not significantly outperform standard treatment alone.

Parents reported no increase in stress levels while using GOLIAH, suggesting that the gaming intervention may be a supportive tool without adding to parental burdens, warranting further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. Jouen, AL., Narzisi, A., Xavier, J., et al.[2020]

A study involving children aged 24 to 48 months found that those with autism spectrum disorder (ASD) showed no differences in visual attention or manual actions during toy play compared to typically developing children.

The results indicate that children with ASD are capable of exploring toys similarly to their peers, highlighting the importance of context in understanding their exploratory behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using head-mounted eye tracking to examine visual and manual exploration during naturalistic toy play in children with and without autism spectrum disorder. Yurkovic, JR., Lisandrelli, G., Shaffer, RC., et al.[2021]

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]

The study involved three children with autism spectrum disorder and focused on teaching them to recognize their play partners' toy preferences during structured play dates.

Using a training method that included rules, preference questions, prompting, and praise, the children successfully learned to offer toys that matched their partners' interests, showing that this approach can generalize to untrained play partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching children with autism to identify and respond appropriately to the preferences of others during play. Najdowski, AC., St Clair, M., Fullen, JA., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Varied treatment response in young children with autism: A relative comparison of structured and naturalistic behavioral approaches. [2021]

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

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

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. [2020]

6. England pubmed.ncbi.nlm.nih.gov

GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. [2020]

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

Using head-mounted eye tracking to examine visual and manual exploration during naturalistic toy play in children with and without autism spectrum disorder. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Teaching children with autism to identify and respond appropriately to the preferences of others during play. [2019]