What side effects are associated with this type of intervention?

Behavioral and educational interventions like JASPER, which focus on improving social communication and engagement through structured play, are generally safe and do not have significant side effects. However, the effectiveness of these interventions can vary, and they require a high level of commitment from both the child and caregivers. In contrast, some CAM therapies, such as megavitamins, chelation, and hyperbaric oxygen therapy, have potential risks and adverse effects, including neuropathy, hepatotoxicity, and barotrauma, and are not recommended due to their unproven efficacy and potential harm.

What prior FDA approvals exist?

The FDA has approved certain medications for the treatment of symptoms associated with autism spectrum disorder (ASD), but there are no specific FDA-approved drugs that directly target social communication and engagement similar to the JASPER intervention. The approved medications primarily address irritability and associated behavioral symptoms. For instance, risperidone and aripiprazole are approved for treating irritability in children with ASD. These medications help manage symptoms such as aggression, self-injury, and severe tantrums but do not specifically enhance social communication and engagement.

What other types of research exist?

Promising novel alternatives to JASPER for autism treatment in 2024 include: 1) Robot-Assisted Therapy (RAAT), which uses interactive robots to engage children in therapeutic sessions and practice complex social interactions. 2) Rhythm and Robotic Interventions, which have shown improvements in joint attention and social attention patterns. 3) Community-based Adaptive Autism Interventions, which tailor interventions based on a child's initial response to improve social-communicative, language, and cognitive outcomes.

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Adaptive Autism Intervention for Toddlers with Autism (CAIT Trial)

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronological age less than 36 months

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks after entry and 3 months after intervention (36 weeks)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medication, traditional side effects are not expected. However, there may be variations in individual responses to therapy such as changes in behavior or stress levels during adaptation to new routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 3 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks after entry and 3 months after intervention (36 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks after entry and 3 months after intervention (36 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks after entry and 3 months after intervention (36 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Communication impairment

Secondary study objectives

Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)

Change in play levels/types using the Short Play and Communication Evaluation (SPACE)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: JASPER (6 weeks)Active Control2 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 Control2 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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism, such as JASPER, work by enhancing social communication and engagement through structured play and interaction. These interventions focus on improving joint attention, symbolic play, and engagement, which are crucial for social development. They involve individualized programming, high staff-to-student ratios, and family involvement, emphasizing attention, imitation, communication, play, social interaction, and regulation. These mechanisms are vital as they address core deficits in Autism, leading to better social and communicative outcomes, thereby improving the overall development and quality of life for Autism patients.

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.Systematic review and guide to management of core and psychiatric symptoms in youth with autism.The effects of embodied rhythm and robotic interventions on the spontaneous and responsive social attention patterns of children with Autism Spectrum Disorder (ASD): A pilot randomized controlled trial.