Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism

Official title

Evaluating Efficacy of a Digital Game Based Therapeutic for Improving Socialization Outcomes in Autistic Children, A Randomized Clinical Trial.

Overview

The following study aims to assess the efficacy of the game-based digital therapeutic, GuessWhat, in improving adaptive socialization skills in children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen.

Detailed description

The following study aims to understand the efficacy of the digital therapeutic, GuessWhat, in improving socialization outcomes in children with Autism Spectrum Disorder (ASD) after regular use over 8 weeks. We will use a cross-over, waitlist control design to examine outcomes after 8 weeks. GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen. The study will enroll parents who are at least 18 years old and have a child between 3 and 12 years old with a formal ASD diagnosis. Parents will be asked to complete two clinical outcome measure questionnaires immediately prior to and up to 1 week after playing GuessWhat with their child 3 times per week for 8 weeks.

Interventions

• Device Charades based mobile digital therapeutic
  The mobile 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. Parents are asked to play with their child 15 minutes 3-4 times per week for 8 weeks.

Primary outcome measures

• Change in parent reported socialization based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, from baseline to week 8 [Time frame: Baseline (Week 0), Week 8]

Secondary outcome measures (2)

• Change in Parental Stress Scale - from baseline to week 8 [Time frame: Baseline (Week 0), Week 8]
• Change in Emotion Recognition from baseline to week 8 [Time frame: Baseline (Week 0), Week 8]

Eligibility criteria

Inclusion criteria

• Parent who is at least 18 years old of child with autism.
• Child with autism is between 3 and 12 years old at time of baseline data collection.
• A professional diagnosis of Autism that is able to be confirmed by negative score on a machine learning based algorithm using items from Mobile Autism Risk Assessment and video based classifier or by a copy of diagnostic report.

Exclusion criteria

• Parent is unable to read the app in the offered languages (English, Spanish, Portuguese)
• Parent does not have an Android or iOS smartphone compatible with GuessWhat App.
• Child has additional psychiatric or neurologic diagnoses including genetic syndromes or epilepsy in addition to autism.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Stanford University — Stanford

Identifiers

NCT: NCT06058104 · 60181-Stanford

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗