What is the mechanism of action of this treatment?

Common treatments for Autism Spectrum Disorder (ASD) such as the Social Communication Growth Charts (SCGC) and Naturalistic Developmental Behavioral Intervention (NDBI) focus on early intervention and parent involvement. SCGC educates parents on early social communication milestones through web-based technology, enabling them to support their child's development. NDBI combines developmental and behavioral strategies in natural settings, implemented by parents or clinicians, to improve social communication and adaptive behaviors. These treatments are crucial as they utilize the early developmental window, enhance parent-child interactions, and are feasible for community-based implementation, potentially leading to better long-term outcomes for children with ASD.

What side effects are associated with this type of intervention?

Behavioral and educational interventions for Autism Spectrum Disorder (ASD), such as the Social Communication Growth Charts (SCGC) and Naturalistic Developmental Behavioral Intervention (NDBI), generally have minimal physical side effects. These interventions focus on improving social communication and adaptive behaviors through structured activities and parent or clinician guidance. Potential side effects may include temporary increases in frustration or anxiety in children as they adapt to new routines and expectations. Additionally, parents may experience stress or fatigue due to the demands of consistent implementation of these interventions. Overall, these treatments are considered safe and beneficial for children with ASD.

What prior FDA approvals exist?

The FDA has approved a few pharmacological treatments for Autism Spectrum Disorder (ASD), primarily focusing on managing symptoms such as irritability. Notably, risperidone and aripiprazole are two antipsychotic medications that have received FDA approval for treating irritability associated with ASD in children and adolescents. These medications help manage symptoms like aggression, self-injury, and severe tantrums. While there are no FDA-approved behavioral interventions like the Social Communication Growth Charts (SCGC) or Naturalistic Developmental Behavioral Intervention (NDBI), these non-pharmacological approaches are widely studied and implemented to improve social communication and developmental outcomes in children with ASD.

What other types of research exist?

Promising alternatives to SCGC and NDBI for ASD treatment include the Picture Exchange Communication System (PECS) and high-tech Speech Generating Devices (SGDs). Both have been shown to improve social communication behaviors in children with ASD. Additionally, the TEACCH program, which uses structured teaching and visual supports, has demonstrated benefits in cognitive and motor functions, as well as social adaptive functioning. These interventions are community-based and have shown positive outcomes in various studies.

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Behavioural Intervention

SCGC + Parent/Clinician Interventions for Autism

N/A

Waitlist Available

Led By Nathan Call, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9, 12, 16, 21, and 30 months of age

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to teach parents how to help their infants develop social communication skills using online tools. It targets infants at risk of ASD to provide early intervention for better developmental outcomes. The treatment educates parents on developmental milestones and offers tailored interventions based on the child's progress.

Who is the study for?

This trial is for infants with a sibling in the Emory Autism Center of Excellence, showing early signs of autism. It's especially for those who didn't respond to initial interventions and are identified by specific autism screening tools.

What is being tested?

The study tests two approaches: web-based parent education on social communication (SCGC) versus usual care, followed by comparing a parent-implemented or clinician-implemented intervention if early signs of ASD persist.

What are the potential side effects?

Since this trial involves educational and behavioral interventions rather than medications, there are no typical drug side effects; however, participation may involve time commitment and emotional impact.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9, 12, 16, 21, and 30 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9, 12, 16, 21, and 30 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9, 12, 16, 21, and 30 months of age for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Autism Diagnostic Observation Schedule Score

Autism Diagnostic Observation Schedule Score in Children Showing Signs of ASD

Communication and Symbolic Behavior Scales (CSBS) Score

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Usual Care in Stage 1 Plus SCGC in Stage 2Experimental Treatment2 Interventions

This arm includes infant participants who did not show early signs of ASD at 12 months of age, following stage 1. In stage 1, infants at 6 months of age with a sibling who is diagnosed with ASD, were randomized to receive usual care for 6 months. In stage 2, infants at 12 months of age who are not showing early signs of ASD were re-randomized to receive the Social Communication Growth Charts (SCGC) intervention from 12 to 21 months of age.

Group II: Usual Care in Stage 1 Plus Parent-Implemented (P-I) Condition in Stage 2Experimental Treatment2 Interventions

This arm includes infant participants who show early signs of ASD at 12 months of age, following stage 1. In stage 1, infants at 6 months of age with a sibling who is diagnosed with ASD, were randomized to receive usual care for 6 months. In stage 2, infants at 12 months of age showing early signs of ASD were randomized to receive a parent-implemented (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) from 12 to 21 months of age.

Group III: Usual Care in Stage 1 Plus Clinician-Implemented (C-I) Condition in Stage 2Experimental Treatment2 Interventions

This arm includes infant participants who show early signs of ASD at 12 months of age, following stage 1. In stage 1, infants at 6 months of age with a sibling who is diagnosed with ASD, were randomized to receive usual care for 6 months. In stage 2, infants at 12 months of age showing early signs of ASD were randomized to receive a clinician-implemented (C-I) condition NDBI based on a hybrid model from 12 to 21 months of age.

Group IV: Social Communication Growth Charts (SCGC) in Stage 1 Plus Usual Care in Stage 2Experimental Treatment2 Interventions

This arm includes participants who did not show early signs of ASD at 12 months of age, following stage 1. In stage 1, infants at 6 months of age with a sibling who is diagnosed with ASD were randomized to receive the Social Communication Growth Charts (SCGC) intervention for 6 months. In stage 2, infants at 12 months of age who are not showing early signs of ASD were re-randomized to receive usual care from 12 to 21 months of age.

Group V: Social Communication Growth Charts (SCGC) in Stage 1 Plus SCGC in Stage 2Experimental Treatment1 Intervention

This arm includes infant participants who did not show early signs of ASD at 12 months of age, following stage 1. In stage 1, infants at 6 months of age with a sibling who is diagnosed with ASD, were randomized to receive the Social Communication Growth Charts (SCGC) intervention for 6 months. In stage 2, infants at 12 months of age who are not showing early signs of ASD were re-randomized to receive the Social Communication Growth Charts (SCGC) intervention from 12 to 21 months of age.

Group VI: SCGC in Stage 1 Plus Parent-Implemented (P-I) Condition in Stage 2Experimental Treatment2 Interventions

This arm includes infant participants who show early signs of ASD at 12 months of age, following stage 1. In stage 1, infants at 6 months of age with a sibling who is diagnosed with ASD, were randomized to receive the Social Communication Growth Charts (SCGC) intervention for 6 months. In stage 2, infants at 12 months of age showing early signs of ASD were randomized to receive a parent-implemented (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) from 12 to 21 months of age.

Group VII: SCGC in Stage 1 Plus Clinician-Implemented (C-I) Condition in Stage 2Experimental Treatment2 Interventions

This arm includes infant participants who show early signs of ASD at 12 months of age, following stage 1. In stage 1, infants at 6 months of age with a sibling who is diagnosed with ASD, were randomized to receive the Social Communication Growth Charts (SCGC) intervention for 6 months. In stage 2, infants at 12 months of age showing early signs of ASD were randomized to receive a clinician-implemented (C-I) condition NDBI based on a hybrid model from 12 to 21 months of age.

Group VIII: Usual Care in Stage 1 Plus Usual Care in Stage 2Active Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parent-Implemented (P-I) Condition

2018

N/A

~270

Clinician-Implemented (C-I) Condition

2018

N/A

~270

Usual Care

1990

Completed Phase 4

~7700

Social Communication Growth Charts (SCGC)

2018

N/A

~270

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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 Spectrum Disorder (ASD) such as the Social Communication Growth Charts (SCGC) and Naturalistic Developmental Behavioral Intervention (NDBI) focus on early intervention and parent involvement. SCGC educates parents on early social communication milestones through web-based technology, enabling them to support their child's development. NDBI combines developmental and behavioral strategies in natural settings, implemented by parents or clinicians, to improve social communication and adaptive behaviors. These treatments are crucial as they utilize the early developmental window, enhance parent-child interactions, and are feasible for community-based implementation, potentially leading to better long-term outcomes for children with ASD.

Novel treatments in autism spectrum disorder.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.