What side effects are associated with this type of intervention?

Behavioral therapies for Autism Spectrum Disorder, such as Applied Behavior Analysis (ABA) and interactive models like the Early Start Denver Model (ESDM), generally have minimal physical side effects. However, they can sometimes cause emotional or psychological stress if not implemented correctly. Complementary and alternative medicine (CAM) therapies, which are less commonly used, may have potential risks and lack robust evidence of efficacy. It is important for caregivers to work closely with healthcare providers to monitor any adverse effects and ensure the chosen therapies are beneficial and safe for the child.

What prior FDA approvals exist?

The FDA has not approved any medications specifically for the core symptoms of Autism Spectrum Disorder (ASD). However, it has approved medications like risperidone and aripiprazole to treat irritability associated with ASD. These medications do not address the core symptoms of ASD, such as social communication difficulties and repetitive behaviors. Behavioral therapies, including those delivered through interactive platforms like the GuessWhat Mobile Application, are commonly used but are not FDA-regulated. These therapies focus on improving social skills, communication, and behavior through structured activities and games.

What other types of research exist?

Promising alternatives to the GuessWhat mobile application for ASD patients include: 1) Lumi Nova, which uses immersive gaming technology to deliver exposure-based cognitive behavioral therapy strategies for managing anxiety in children. 2) INTERACCT app, a gamified mobile app designed for adolescents undergoing cancer and hematopoietic stem cell transplantation, which could be adapted for ASD patients to track real-time self-reported symptoms and health status data. Both apps have shown potential in their respective fields and could offer engaging and effective therapeutic options for ASD patients.

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Behavioural Intervention

GuessWhat Mobile App Therapy for Autism

N/A

Waitlist Available

Led By Dennis P Wall, PhD

Research Sponsored by Stanford 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 baseline through week 4 (assessed at week 4)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the GuessWhat mobile app, which has games to help children with Autism Spectrum Disorder (ASD) improve their social and emotional skills. It targets children aged 3-12 with ASD. The games help kids practice understanding emotions and social cues in a fun way.

Who is the study for?

This trial is for parents over 18 with a child aged 3-12 diagnosed with Autism Spectrum Disorder. The parent must be able to read English and have an iOS or Android smartphone compatible with the GuessWhat Mobile App.

What is being tested?

The study tests the effectiveness of the GuessWhat Mobile App, which offers games designed for behavioral therapy in children with autism. Families will use their smartphones to engage their child in these therapeutic games as per a set schedule.

What are the potential side effects?

Since this intervention involves using a mobile app for therapy, there are no direct medical side effects. However, screen time considerations and ensuring engagement without causing frustration are important factors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 4 (assessed at week 4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 4 (assessed at week 4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 4 (assessed at week 4) 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 Parent Reported Socialization Based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, From Baseline to Week 4

Secondary study objectives

Change in Emotion Recognition From Baseline to Week 4

Change in Parental Stress Scale - From Baseline to Week 4

GuessWhat App Usage Data

Other study objectives

mobile autism risk assessment score at baseline

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

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

The GuessWhat app is a charades style game and app that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. Parent and child will be encouraged to play using the emojis and emotion game mode at least 3 individual game sessions per week. Parents are asked to play GuessWhat with their child 3-4 times per week for 4 weeks.

Group II: Treatment as UsualActive Control1 Intervention

Participants in control group will continue their treatment as usual.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GuessWhat Mobile App

2021

N/A

~550

Do I qualify?Apply below to find out

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 therapies for Autism Spectrum Disorder (ASD), such as Applied Behavior Analysis (ABA) and the Early Start Denver Model (ESDM), work by reinforcing desired behaviors and reducing unwanted behaviors through structured, repetitive activities and positive reinforcement. These therapies often incorporate play and social interaction to improve communication, social skills, and adaptive behaviors. Interactive games, like those in the GuessWhat app, engage children in fun, motivating activities that promote learning and development. Early and intensive behavioral interventions can lead to significant improvements in language, cognitive, and social functioning, which are critical for the overall development and quality of life of ASD patients.

Pivotal response treatment for preschoolers with autism spectrum disorder: Defining a predictor profile.Neurologic treatment strategies in autism: an overview of medical intervention strategies.Comparison of behavioural and natural play interventions for young children with autism.