Adaptive Autism Intervention for Toddlers with Autism

(CAIT Trial)

Overseen By Consuelo Garcia, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Cerebral palsy, Down syndrome

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: 13

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a program to help toddlers with autism improve their social and communication skills. The program starts with play-based activities and is adjusted based on each child's progress. These activities have been shown to improve social communication in young children with autism. The goal is to find the best way to support these children in everyday settings.

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

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on behavioral interventions for toddlers with autism.

Do I have to stop my child's current medications for this trial?

The trial protocol does not specify whether participants must stop taking their current medications, so it's best to discuss this with the trial coordinators or your child's doctor.

What data supports the idea that Adaptive Autism Intervention for Toddlers with Autism is an effective treatment?

The available research shows that Adaptive Autism Intervention for Toddlers with Autism, such as JASPER, is effective in improving language and play skills in young children with autism. One study found that children who received joint attention and play interventions showed greater improvements in language skills compared to those who did not receive these interventions. Another study demonstrated that teachers could successfully implement these interventions in classrooms, leading to significant improvements in joint attention and play skills. Additionally, a pilot study showed that minimally verbal children with autism who received JASPER treatment had more diverse play and better engagement in the classroom. These findings suggest that this treatment can effectively enhance important developmental skills in children with autism. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment jasPEER, JASPER with a peer, JASPER, Joint Attention Symbolic Play Engagement & Regulation, JASPER Plus+, JASPER Plus+, JASPER with Structured Teaching, Structured Teaching, Structured Teaching, Direct Instruction, Applied Behavior Analysis (ABA) component for toddlers with autism?

Research shows that interventions focusing on joint attention and symbolic play, like JASPER, can significantly improve language outcomes and play diversity in young children with autism. These treatments help enhance social engagement and communication skills, which are crucial for children with autism. ^{1 2 3 4 5}

What safety data exists for the Adaptive Autism Intervention for Toddlers with Autism?

The studies provided do not directly address safety data for the intervention. However, they suggest that interventions like JASPER, which focus on joint attention and play, are beneficial and can be implemented in various settings (classroom, parent-mediated) without reported adverse effects. These interventions have shown improvements in joint attention, play skills, and language outcomes in young children with autism, indicating they are generally well-tolerated and effective. ^{1 3 4 5 6}

Is the Adaptive Autism Intervention for Toddlers with Autism safe for humans?

The studies on interventions like JASPER, which focus on play and joint attention for young children with autism, do not report any safety concerns. These interventions are generally classroom-based or parent-mediated and aim to improve social and communication skills. ^{1 3 4 5 6}

Is JASPER a promising treatment for toddlers with autism?

Yes, JASPER is a promising treatment for toddlers with autism. It helps improve important skills like joint attention and play, which are crucial for social interaction and communication. Studies show that children who receive JASPER make significant progress in these areas, and even brief sessions can lead to noticeable improvements. ^{1 4 5 6 7}

How is the JASPER treatment different from other autism treatments?

JASPER is unique because it focuses on improving joint attention and symbolic play skills in young children with autism, using a developmentally grounded approach that involves parents and teachers in everyday routines. This treatment is distinct from others as it emphasizes building social-communicative skills through play and interaction, rather than traditional behavioral therapies. ^{1 4 5 6 7}

Eligibility Criteria

This trial is for toddlers aged 2-3 with autism spectrum disorder (ASD) who are receiving early intervention in East Harlem and the Bronx, NY. They must have a clinical ASD diagnosis or ADOS-2 confirmation, and their caregivers must consent to learn intervention strategies if required. Children with co-morbid disorders like cerebral palsy or Down syndrome cannot participate.

Inclusion Criteria

My caregiver agrees to learn and use new care strategies if needed.

Diagnosis of ASD based on clinical report or ADOS-2 if needed

I am under 3 years old.

Exclusion Criteria

The child has other health conditions like cerebral palsy or Down syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive JASPER intervention for either 6 or 12 weeks, depending on randomization

6-12 weeks

Daily sessions, 5 days a week

Stage 2 Treatment

Participants continue with JASPER or are augmented with JASPER Plus+ based on response

12-18 weeks

Daily sessions, 5 days a week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at 3 months post exit

Treatment Details

Interventions

• jasPEER
• JASPER
• JASPER Plus+
• Structured Teaching

Trial Overview The study tests an adaptive autism intervention called JASPER, alone or combined with structured teaching (JASPER Plus+), tailored based on the child's initial response. It aims to improve social communication and cognitive outcomes over a year through two phases of individualized treatment involving daily sessions.

Participant Groups

Group I: JASPER (6 weeks) Active Control 2 Interventions

Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 6 weeks. If child is an early responder, he/she will continue to do JASPER daily, 5 times a week, for the remaining 18 weeks of the study. If child is a slow responder, he/she can get randomized to receive 30 minutes of JASPER Plus+ and 30 minutes of JASPER with a TA daily, 5 days a week for the remaining 18 weeks of the study. Or Child can get randomized to continue his/her daily sessions of JASPER with the TA for an hour each day, 5 days a week for the following 18 weeks of the study.

Group II: JASPER (12 weeks) Active Control 2 Interventions

Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 12 weeks. If child is an early responder, he/she will do JASPER for 60 minutes with TA, 5 times a week, for the remaining 12 weeks of the study. If child is a slow responder, he/she can get randomized to receive 30 minutes of JASPER Plus+ and 30 minutes of JASPER with a TA daily, 5 days a week for the remaining 12 weeks of the study. Or Child can get randomized to continue his/her daily sessions of JASPER with the TA for an hour each day, 5 days a week for the following 12 weeks of the study.

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]

Toddlers diagnosed with autism spectrum disorder (ASD) demonstrated significantly less pretend play and social engagement during interactions compared to low-risk toddlers with typically-developing siblings and high-risk toddlers without a diagnosis.

The study found that lower levels of pretend play and social engagement in high-risk toddlers were linked to more severe symptoms of ASD, suggesting that these behaviors may be early indicators of emerging autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretend Play and Social Engagement in Toddlers at High and Low Genetic Risk for Autism Spectrum Disorder. Campbell, SB., Leezenbaum, NB., Mahoney, AS., et al.[2019]

The study found that the quality of interaction between toddlers and their caregivers significantly influences the development of play behavior, highlighting the importance of caregiver engagement.

For toddlers with autism, the security of attachment to their caregivers was a stronger predictor of play behavior than the autism diagnosis itself, suggesting that nurturing relationships can enhance social development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Play behavior and attachment in toddlers with autism. Naber, FB., Bakermans-Kranenburg, MJ., van Ijzendoorn, MH., et al.[2018]

A pilot study involving 33 children with autism aged 3 to 6 years demonstrated that a classroom-based intervention significantly improved joint engagement and joint attention skills when implemented by teachers.

Teachers were able to effectively integrate strategies for symbolic play and joint attention into their routines, highlighting the potential for such interventions to enhance social skills in young children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study. Wong, CS.[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]

A parent-mediated intervention model effectively promoted joint attention in three toddlers with early-identified autism, demonstrating improvements across various phases of the program.

Two of the toddlers showed sustained engagement in joint attention, highlighting the importance of developmentally appropriate methods that leverage the parent-child relationship in early autism interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting joint attention in toddlers with autism: a parent-mediated developmental model. Schertz, HH., Odom, SL.[2019]

The JASPER intervention for toddlers with autism was effectively implemented by teaching assistants, showing that children in both years made similar improvements in joint attention skills, indicating the intervention's efficacy.

While the intervention was sustained into the second year, children from the first year showed significantly greater gains in play skills, suggesting that ongoing support may be necessary to further enhance play development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Community Implementation of JASPER Intervention with Toddlers with Autism. Shire, SY., Shih, W., Chang, YC., et al.[2020]

References

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

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

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

Pretend Play and Social Engagement in Toddlers at High and Low Genetic Risk for Autism Spectrum Disorder. [2019]

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

Play behavior and attachment in toddlers with autism. [2018]

4. England pubmed.ncbi.nlm.nih.gov

A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study. [2019]

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

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

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

Promoting joint attention in toddlers with autism: a parent-mediated developmental model. [2019]

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

Sustained Community Implementation of JASPER Intervention with Toddlers with Autism. [2020]