What is the mechanism of action of this treatment?

Behavioral and educational interventions, such as the JASPER play-based approach, work by enhancing social communication and engagement through structured play and interaction. These interventions often involve techniques like modeling, prompting, and reinforcement to encourage desired behaviors and skills. The mechanisms of action include improving joint attention, increasing symbolic play, and fostering social reciprocity. These treatments are crucial for autism patients as they target core deficits, helping children develop essential social and communication skills that improve their overall functioning and quality of life.

What side effects are associated with this type of intervention?

Play-based interventions like JASPER, which focus on improving social communication and engagement, generally have minimal side effects. These interventions are behavioral and educational in nature, aiming to enhance interaction skills through structured play. Common side effects are typically related to the intensity and duration of the sessions, such as fatigue or frustration in children. In contrast, pharmacological treatments for autism, such as those for irritability and emotional dysregulation, can have more significant side effects, including gastrointestinal issues, sleep disturbances, and potential behavioral changes. It is important to monitor any therapy closely to ensure it is beneficial and to manage any adverse effects.

What prior FDA approvals exist?

The FDA has not approved any drugs specifically for the core symptoms of Autism Spectrum Disorder (ASD). However, medications such as risperidone and aripiprazole have been approved to treat irritability associated with ASD. These medications do not directly address the social communication and engagement goals targeted by the JASPER intervention. JASPER, a play-based therapy, focuses on improving social communication and engagement, which is different from the pharmacological approach of managing associated symptoms like irritability.

What other types of research exist?

Promising novel alternatives to JASPER for autism treatment in 2024 include: 1) Robot-Assisted Autism Therapy (RAAT), which uses interactive robots to engage children in therapeutic sessions and practice complex social interactions. 2) Cannabinoid treatments, such as Cannabidiol (CBD) and Cannabidivarin (CBDV), which have shown potential in managing behavioral problems in children with autism. 3) ABRACADABRA (ABRA) literacy instruction, a web application designed to promote literacy development, which has been effective in small group settings for children with autism.

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Behavioral Intervention

JASPER Intervention for Autism (EBJ 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

The child must be between 18 months and 5 years of age

The sample will be limited to children with confirmed diagnosis and nonverbal mental ages greater than or equal to 12 months

Must not have

Children that do not have a mental age greater than or equal to 12 months

Children under the age of 18 months or older than 5 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up entry (1st month of the study), t2 (10 weeks after entry), t3 (20 weeks after entry)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing JASPER, a play-based therapy, on young children with autism who have limited verbal skills. The therapy uses guided play to help these children improve their social and communication abilities. JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation) is a naturalistic developmental behavioral intervention that has been found effective for promoting social communication in young children with autism.

Who is the study for?

This trial is for children aged 18 months to 5 years with Autism Spectrum Disorder who are minimally verbal or have emerging phrase speech. They must have a nonverbal mental age of at least 12 months and a confirmed diagnosis of autism.

What is being tested?

The study tests JASPER, a play-based intervention for autism, delivered by either clinicians or parents. It measures the effectiveness using BOSCC and ELSA-T assessments over a period of 20 weeks, with adjustments based on initial response after the first half.

What are the potential side effects?

Since JASPER is a behavioral intervention involving structured play activities facilitated by clinicians or caregivers, it does not involve medication; therefore, traditional physical side effects are not expected.

Eligibility Criteria

Inclusion Criteria

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

Select...

My child is between 18 months and 5 years old.

Select...

My child has a confirmed diagnosis and understands things like a 1-year-old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child's mental age is under 12 months.

Select...

My child is either younger than 18 months or older than 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ entry (1st month of the study), t2 (10 weeks after entry), t3 (20 weeks after entry)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~entry (1st month of the study), t2 (10 weeks after entry), t3 (20 weeks after entry)

This trial's timeline: 3 weeks for screening, Varies for treatment, and entry (1st month of the study), t2 (10 weeks after entry), t3 (20 weeks after entry) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in frequency of language utterances and number of conversation turns using the Elicitation of Language Samples for Analysis- Toddlers (ELSA-T)

Change in social communication using the Brief Observation of Social Communication Change (BOSCC)

Other study objectives

ADOS Toddler Module or Module 1 or Module 2 (depends on child's language level)

Change in Joint Engagement on the Caregiver-Child Play Interaction (CCX) over the course of the study.

Demographic and Medical Questionnaire

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: parent-mediated JASPERExperimental Treatment1 Intervention

This group will consist of the therapist assisting the parent implement JASPER on the child twice a week.

Group II: clinician-mediated JASPERExperimental Treatment1 Intervention

This group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week.

0 / 4Eligibility 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

Behavioral and educational interventions, such as the JASPER play-based approach, work by enhancing social communication and engagement through structured play and interaction. These interventions often involve techniques like modeling, prompting, and reinforcement to encourage desired behaviors and skills. The mechanisms of action include improving joint attention, increasing symbolic play, and fostering social reciprocity. These treatments are crucial for autism patients as they target core deficits, helping children develop essential social and communication skills that improve their overall functioning and quality of life.

Novel treatments in autism spectrum disorder.Commentary: Randomized controlled trials in autism spectrum disorder: state of the field and challenges for the future.Systematic review and guide to management of core and psychiatric symptoms in youth with autism.