What side effects are associated with this type of intervention?

Behavioral and educational interventions such as DTT, JASPER, and EMT are generally considered safe and are associated with minimal side effects. However, they can be intensive and may lead to stress or burnout for both the child and the caregivers if not managed properly. Pharmacologic treatments, which are sometimes used alongside behavioral interventions, can have side effects such as weight gain, drowsiness, and gastrointestinal issues. Complementary and alternative therapies, while popular, often lack robust evidence for efficacy and can carry risks such as nutritional deficiencies or interactions with other treatments.

What prior FDA approvals exist?

The FDA has approved a few medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD), such as risperidone and aripiprazole. These medications are not directly related to the behavioral interventions like DTT, JASPER, and CET, which are more focused on developmental and educational approaches rather than pharmacological treatment. The Adaptive Intervention Approach, which tailors these behavioral therapies based on individual needs, aligns with the broader strategy of personalized and intensive behavioral interventions that have shown efficacy in improving outcomes for children with ASD.

What other types of research exist?

Promising novel alternatives to the Adaptive Intervention Approach for ASD patients include: 1) Technology-based interventions such as computer programs, virtual reality, and interactive DVDs, which have shown positive outcomes in meta-analyses. 2) Telehealth training for parents to implement interventions like Discrete Trial Training (DTT) at home, which has demonstrated efficacy. 3) WHO Caregiver Skills Training (CST) delivered in public health settings, which has shown significant effects on parent skills and child gestures. These alternatives offer innovative and accessible options for ASD treatment in 2024.

← Back to Search

DTT + JASPER for Autism

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

children meeting ADOS-2 criteria for ASD

age 36-59 months

Must not have

We will exclude children who have sensory and motor impairments (e.g., visual impairment, deaf or hard of hearing) and with known genetic syndromes (e.g., Down Syndrome)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (entry), week 10, week 20, week 30, age 6 (follow up)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve language skills in preschool children with autism using a structured teaching and social interaction-based learning program. The program is adjusted based on each child's progress. The goal is to help these children develop better communication skills and avoid being minimally verbal by age 6.

Who is the study for?

The PRISM study is for preschoolers aged 36-59 months with Autism Spectrum Disorder who speak less than 20 functional words. They must have had over 3 months of early intervention, stable medication for the past half year, and a nonverbal mental age above one year. Children with sensory/motor impairments or genetic syndromes like Down Syndrome are not eligible.

What is being tested?

This trial tests an adaptive two-stage language development approach over 20 weeks for minimally verbal children with ASD in community settings. It aims to personalize treatment by choosing between DTT (Discrete Trial Training), JASPER, and CET interventions based on each child's needs.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, there may be varying responses to therapy such as changes in behavior or emotional distress.

Eligibility Criteria

Inclusion Criteria

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

Select...

My child has been diagnosed with autism.

Select...

I am between 3 and 5 years old.

Exclusion Criteria

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

Select...

I do not have sensory, motor impairments, or known genetic syndromes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (entry), week 10, week 20, week 30, age 6 (follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (entry), week 10, week 20, week 30, age 6 (follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (entry), week 10, week 20, week 30, age 6 (follow up) 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 of spontaneous utterances (SCU) from the Language Sample throughout the study.

Secondary study objectives

Change in Joint Engagement on the Adult-Child Interaction (ACX) over the course of the study.

Change in receptive language using the Preschool Language Scales-5 (PLS-5) throughout the study.

Presence of word combinations in the Language Sample over the course of the study.

Other study objectives

Determine eligibility on nonverbal mental age using the Mullen Scales of Early Learning (MSEL)

Presence of joint attention initiations using the Early Social-Communication Scales

Track the levels of spontaneous play acts using The Structured Play Assessment-R over the course of the study.

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: JASPERActive Control1 Intervention

Child will spend 2 hours per week (2 days, 1 hour per day) for the first 10 weeks doing JASPER. If the child is an early responder, he/she will remain in the same course for the following 10 weeks. If child is a slow responder, he/she will be randomized for either combined \& enhanced treatment (CET) for 2 hours a week (2 days, 1 hour per day) or Intensified JASPER for 4 hours a week (4 days, 1 hour per day).

Group II: DTTActive Control1 Intervention

Child will spend 2 hours per week (2 days, 1 hour per day) for the first 10 weeks doing DTT. If the child is an early responder, he/she will remain in the same course for the following 10 weeks. If child is a slow responder, he/she will be randomized for either combined \& enhanced treatment (CET) for 2 hours a week (2 days, 1 hour per day) or Intensified DTT for 4 hours a week (4 days, 1 hour per day).

0 / 3Eligibility 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

Discrete Trial Training (DTT) is a structured behavioral intervention that breaks down skills into small, teachable components and uses reinforcement to encourage desired behaviors. JASPER focuses on improving joint attention and symbolic play skills, which are critical for social communication development. Enhanced Milieu Teaching (EMT) combines behavioral and developmental principles to promote spontaneous communication in naturalistic settings. These treatments are important for ASD patients because they target specific deficits in communication and social interaction, which are core challenges in ASD. By tailoring these interventions to individual needs, they can more effectively promote skill development and improve overall functioning.

Research-Based Intervention (RBI) for Autism Spectrum Disorder: Looking beyond Traditional Models and Outcome Measures for Clinical Trials.Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.