Adaptive Autism Intervention for Toddlers with Autism
(CAIT Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of California, Los Angeles
No Placebo Group
Approved in 1 jurisdiction
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.
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.
12345What 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.
13456Is 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.
14567Eligibility 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.
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New York Center for Infants and Toddlers, Inc.New York, NY
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Language outcome in autism: randomized comparison of joint attention and play interventions. [2022]This study reports results of a randomized controlled trial aimed at joint attention (JA) and symbolic play (SP) in preschool children with autism, with prediction to language outcome 12 months later. Participants were 58 children (46 boys) with autism between 3 and 4 years of age. Children were randomized to a JA intervention, an SP intervention, or control group. Interventions were conducted 30 min daily for 5-6 weeks. Assessments of JA skills, SP skills, mother-child interactions, and language development were collected at 4 time points: pre- and postintervention and 6 and 12 months postintervention by independent testers. Results indicate that expressive language gains were greater for both treatment groups compared with the control group, and results could not be explained by differences in other interventions in which children participated. For children beginning treatment with the lowest language levels, the JA intervention improved language outcome significantly more than did the SP or control interventions. These findings suggest clinically significant benefits of actively treating JA and SP skills in young children with autism.
Pretend Play and Social Engagement in Toddlers at High and Low Genetic Risk for Autism Spectrum Disorder. [2019]Toddlers with an older sibling with autism spectrum disorder (ASD) and low risk (LR) toddlers with typically-developing older siblings were observed during free play with a parent and elicited pretend with an examiner at 22-months. Functional and pretend play, children's social engagement, and parent sensitivity were assessed during free play. Complexity of play was assessed during the elicited pretend task. Toddlers with an ASD diagnosis showed less pretend play across contexts and less social engagement with parents or the examiner than either LR toddlers or high risk toddlers without a diagnosis (HR-noASD). Lower levels of pretend play and social engagement were associated with symptom severity within the high risk group, reflecting emerging ASD in toddlerhood.
Play behavior and attachment in toddlers with autism. [2018]Play helps to develop social skills. Children with autism show deviances in their play behavior that may be associated with delays in their social development. In this study, we investigated manipulative, functional and symbolic play behavior of toddlers with and without autism (mean age: 26.45, SD 5.63). The results showed that the quality of interaction between the child and the caregiver was related to the development of play behavior. In particular, security of attachment was related to better play behavior. When the developmental level of the child is taken into account, the attachment relationship of the child with the caregiver at this young age is a better predictor of the level of play behavior than the child's disorder.
A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study. [2019]The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool special education teachers were randomly assigned to one of three groups: (1) symbolic play then joint attention intervention, (2) joint attention then symbolic intervention, and (3) wait-list control period then further randomized to either group 1 or group 2. In the intervention, teachers participated in eight weekly individualized 1-h sessions with a researcher that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities. The main child outcome variables of interest were collected through direct classroom observations. Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms. Furthermore, multilevel analyses showed significant increases in joint attention and symbolic play skills. Thus, these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism.
Preschool based JASPER intervention in minimally verbal children with autism: pilot RCT. [2021]In this pilot study, we tested the effects of a novel intervention (JASPER, Joint Attention Symbolic Play Engagement and Regulation) on 3 to 5 year old, minimally verbal children with autism who were attending a non-public preschool. Participants were randomized to a control group (treatment as usual, 30 h of ABA-based therapy per week) or a treatment group (substitution of 30 min of JASPER treatment, twice weekly during their regular program). A baseline of 12 weeks in which no changes were noted in core deficits was followed by 12 weeks of intervention for children randomized to the JASPER treatment. Participants in the treatment group demonstrated greater play diversity on a standardized assessment. Effects also generalized to the classroom, where participants in the treatment group initiated more gestures and spent less time unengaged. These results provide further support that even brief, targeted interventions on joint attention and play can improve core deficits in minimally verbal children with ASD.
Promoting joint attention in toddlers with autism: a parent-mediated developmental model. [2019]Joint attention, a foundational nonverbal social-communicative milestone that fails to develop naturally in autism, was promoted for three toddlers with early-identified autism through a parent-mediated, developmentally grounded, researcher-guided intervention model. A multiple baseline design compared child performance across four phases of intervention: focusing on faces, turn-taking, responding to joint attention, and initiating joint attention. All toddlers improved performance and two showed repeated engagement in joint attention, supporting the effectiveness of developmentally appropriate methods that build on the parent-child relationship. A complementary qualitative analysis explored family challenges, parent resilience, and variables that may have influenced outcomes. Intervention models appropriate for toddlers with autism are needed as improved early identification efforts bring younger children into early intervention services.
Sustained Community Implementation of JASPER Intervention with Toddlers with Autism. [2020]Intervention research is increasingly conducted in community settings, however it is not clear how well practices are sustained locally or how children progress once external research support is removed. Two school-year cohorts of toddlers with autism (year 1: n = 55, year 2: n = 63) received Joint Attention, Symbolic Play, Engagement, and Regulation (JASPER) intervention from teaching assistants (TAs) with external support in year 1 and local, internal support in year 2. TAs sustained intervention strategies with more modest maintenance of high-level skills. Children in both years 1 and 2 made similar gains in initiations of joint attention during independent assessment. Year 1 children made significantly greater play gains. JASPER sustained into year 2, however advancing play may require additional supports.