Trial Outcomes & Findings for A Lead-in Study Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism (NCT NCT04739982)

Last Updated: 2024-09-19

Results Overview

Vineland Adaptive Behavior Scales, 3rd edition (VABS-3) Socialization subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents. Scores from the socialization domain of the VABS-III reflects one's functioning in social situations. The socialization subscale is up to 112 items depending on age and development, where raw scores are converted to IQ-type standard scores with mean 100 and standard deviation of 15, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning. The range for each subscale is 20 to 140.

Recruitment status

COMPLETED

Study phase

Target enrollment

541 participants

Primary outcome timeframe

Baseline (Week 0), Week 4

Results posted on

2024-09-19

Participant Flow

Participants were recruited between June 1, 2021 and July 1, 2022 using emails and online research listings.

Participant milestones

Participant milestones
Measure	Treatment 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.	Treatment as Usual Participants in control group will continue their treatment as usual.
Overall Study STARTED	322	219
Overall Study Completed Week 4 Survey	127	149
Overall Study COMPLETED	127	149
Overall Study NOT COMPLETED	195	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment 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.	Treatment as Usual Participants in control group will continue their treatment as usual.
Overall Study Lost to Follow-up	176	65
Overall Study Withdrawal by Subject	19	0
Overall Study Protocol Violation	0	5

Baseline Characteristics

A Lead-in Study Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=127 Participants 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.	Treatment as Usual n=149 Participants Participants in control group will continue their treatment as usual.	Total n=276 Participants Total of all reporting groups
Age, Categorical <=18 years	127 Participants n=5 Participants	149 Participants n=7 Participants	276 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7.89 years n=5 Participants	7.47 years n=7 Participants	7.66 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	118 Participants n=7 Participants	212 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized East Asian	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Unknown / Not Listed	34 Participants n=5 Participants	42 Participants n=7 Participants	76 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/White	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Vineland Adaptive Behavior Scales-3 Socialization Subscale Standard Score	72.30 score on a scale STANDARD_DEVIATION 16.68 • n=5 Participants	66.97 score on a scale STANDARD_DEVIATION 18.42 • n=7 Participants	69.42 score on a scale STANDARD_DEVIATION 17.84 • n=5 Participants
Parental Stress Scale Score	47.06 score on a scale STANDARD_DEVIATION 9.13 • n=5 Participants	47.95 score on a scale STANDARD_DEVIATION 9.81 • n=7 Participants	47.54 score on a scale STANDARD_DEVIATION 9.40 • n=5 Participants
Mobile Autism Risk Assessment	-3.39 score on a scale n=5 Participants	-3.82 score on a scale n=7 Participants	-3.62 score on a scale n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 4

Population: Participants who completed follow-up survey at week 4

Outcome measures

Outcome measures
Measure	Treatment n=127 Participants 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.	Treatment as Usual n=149 Participants Participants in control group will continue their treatment as usual.
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	.56 score on a scale Standard Error .98	.23 score on a scale Standard Error .96

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4

Population: Participants who completed follow-up survey at week 4

The Parental Stress Scale is an 18-item parent report scale that evaluates the extent of parent stress. Scores range from 18-90, where higher scores indicate a higher level of Parental stress. Parents completed this survey, but were not considered to be enrolled in the study.

Outcome measures

Outcome measures
Measure	Treatment n=127 Participants 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.	Treatment as Usual n=149 Participants Participants in control group will continue their treatment as usual.
Change in Parental Stress Scale - From Baseline to Week 4	-5.18 units on a scale Standard Error .76	-7.01 units on a scale Standard Error 1.17

SECONDARY outcome

Timeframe: Baseline through week 4 (assessed at week 4)

Population: Participants with available data. Only the Treatment Group is included in the analysis, as the Treatment as Usual Group did not use the app.

App usage data by participants (children) comprised of number of MojiMatch and Charades Games started.

Outcome measures

Outcome measures
Measure	Treatment n=90 Participants 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.	Treatment as Usual Participants in control group will continue their treatment as usual.
GuessWhat App Usage Data	15.77 number of games Standard Deviation 25.43	—

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4

Population: Participants with available data.

Study team used an image based emotion recognition task where participants (children) will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants select 1 of 8 available Ekman emotion labels for 16 facial emotional image stimuli presented in random order. Correct responses will be measured against a predetermined majority rules consensus of the emotional content of the GIFs. Scores range from 0 (no emotional image stimuli correctly identified) to 16 (all correctly identified).

Outcome measures

Outcome measures
Measure	Treatment n=97 Participants 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.	Treatment as Usual n=102 Participants Participants in control group will continue their treatment as usual.
Change in Emotion Recognition From Baseline to Week 4	-.37 score on a scale Standard Deviation 4.34	-1.12 score on a scale Standard Deviation 3.42

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kaiti Dunlap, Clinical Research Coordinator

Stanford University

Phone: 650-497-9214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place