Clinical trial NCT04739982: A Lead-in Study Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism
Official title: A Lead-in Study Evaluating Mobile Game Based Therapy Among Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: digital health
mhealth
autism
intervention
behavioral therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2021-02-05
Enrollment: 541
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The following study aims to assess the efficacy, safety data, and best outcome measurements of the mobile game platform, GuessWhat, in delivering behavioral therapy to 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 and safety of the mobile game platform, GuessWhat, in delivering behavioral therapy to 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. 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 4 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.

Exclusion Criteria:

1. Parent is unable to read English.
2. Parent does not have an Android or iOS smartphone compatible with GuessWhat App--the app will be available on Android after further development and we will notify interested families when it becomes available.

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 4
timeFrame: Baseline (Week 0), Week 4
Secondary outcomes:
measure: Change in Parental Stress Scale - From Baseline to Week 4
timeFrame: Baseline (Week 0), Week 4
measure: GuessWhat App Usage Data
timeFrame: Baseline through week 4 (assessed at week 4)
measure: Change in Emotion Recognition From Baseline to Week 4
timeFrame: Baseline (Week 0), Week 4
Other outcomes:
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: