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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best mix of interventions to help toddlers with autism improve their social, language, and cognitive skills. It uses a program called JASPER (Joint Attention Symbolic Play Engagement & Regulation), which focuses on social communication through play. Toddlers begin with daily sessions and, based on their progress, may continue with JASPER or add other activities to boost their growth. This trial includes toddlers diagnosed with autism who are part of a community-based early intervention program, and caregivers can learn the strategies if needed. As an unphased trial, it offers families a unique opportunity to explore innovative strategies that could significantly enhance their child's developmental progress.

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

Research shows that the JASPER program is generally well-received by children with autism. Studies have found that children participating in JASPER sessions made significant progress in areas like shared attention and communication skills. These studies reported no major negative effects, indicating that JASPER is a safe option for young children with autism. As a type of behavioral therapy rather than medication, JASPER avoids many side effects associated with drugs. Overall, evidence supports JASPER as a safe and helpful approach for toddlers with autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about JASPER for toddlers with autism because it offers a tailored approach that adapts to each child's response. Unlike traditional methods like ABA therapy, which often follow a more rigid structure, JASPER is flexible, allowing for adjustments based on whether a child is an early or slow responder. This personalization can lead to more effective, engaging sessions that nurture the child's unique developmental needs. Additionally, JASPER focuses on enhancing social communication through play, which is a natural and enjoyable way for toddlers to learn, potentially leading to better outcomes.

What evidence suggests that this trial's treatments could be effective for toddlers with autism?

Research has shown that JASPER, a program designed to aid social communication, yields promising results for young children with autism. Most studies have found that children participating in JASPER improve in at least one developmental area, such as social communication skills. JASPER specifically enhances joint attention, which involves focusing on the same thing as someone else—an essential skill for social interaction. In some studies, improvements in joint attention significantly contributed to better social communication. Caregivers also observed that children became more engaged and better behaved during play, underscoring JASPER's potential to help toddlers with autism develop crucial social skills. In this trial, participants will be randomized to receive JASPER for either 6 weeks or 12 weeks, with adjustments based on their response to the intervention. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

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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 ...

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JASPER Intervention for Autism (EBJ Trial)

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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).

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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, ...