Clinical trial NCT06058104: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: digital
mobile health
autism
pediatrics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We will use block randomization stratified by sex to assign participants to the group where they will use the treatment immediately for 8 weeks or the cross over waitlist control, where they will be able to use the treatment after 8 weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Parent who is at least 18 years old of child with autism.
2. Child with autism is between 3 and 12 years old at time of baseline data collection.
3. 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:

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

Primary outcomes:
measure: 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
timeFrame: Baseline (Week 0), Week 8
Secondary outcomes:
measure: Change in Parental Stress Scale - from baseline to week 8
timeFrame: Baseline (Week 0), Week 8
measure: Change in Emotion Recognition from baseline to week 8
timeFrame: Baseline (Week 0), Week 8
Other outcomes:
measure: mobile autism risk assessment score at baseline
timeFrame: baseline (week 0)
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Dennis P Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References: