Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
Phase: NA
Conditions: Autism Spectrum Disorder, Parents
Sponsor: University of California, Santa Barbara

 
 
Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program 
 
ID: 24-21-0034 
 
Document Date: 3/5/2021 

APPLICATION FOR HUMAN SUBJECTS USE
Protocol Number:    24-21-0034
Investigator(s):
Name
Title
Email
Phone
Elizabeth McGarry
emcgarry@umail.ucsb.edu
Andrew Maul
amaul@education.ucsb.edu
510-363-0725
Emily Ferguson
eferguson@umail.ucsb.edu
Maria Jimenez Munoz
mariajimenezmunoz@umail.ucsb.
edu
Rachel Schuck
rkschuck@umail.ucsb.edu
Anthony Osuna
aosuna@umail.ucsb.edu
Kaitlynn Penner
kpenner@umail.ucsb.edu
Kaylin Russell
krussell@umail.ucsb.edu
Alexis Arias
aarias@umail.ucsb.edu
Faculty Advisor:
Name
Title
Email
Phone
Ty Vernon
tyvernon@ucsb.edu
8058955567
Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
Titles:
Funding Source:
ORBiT Funding Source:
Admin 
Dept/ORU:
US Army Medial Research Acquisition Activity - 20200072
CCSP                                              
Submission Type:
R-Renewal No 
Changes
Clinical Trial:
Yes
DoD:
Does your project have DoD funding? -Yes
Collaborations:
Name
Institution
IRB Approval Through Home Institution
Proxy(s):
Name
Title
Email
Phone
Project Type:
Faculty-led
Page 1 of 17
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CONFLICT OF INTEREST - Disclosable financial interests are:
1)
No-
Ownership interest, stock, stock options, or other financial interest related to the research, unless it meets all 
four tests:
- Less than $10,000 when aggregated for the immediate family and
- Publicly traded on a stock exchange and
- Value will not be affected by the outcome of the research and
- Less than 5% interest in any one single entity.
2)
No-
Compensation related to the research, including salary, consultant payments, honoraria, royalty payments, 
dividends, loans, or any other payments or consideration with value, unless it meets both of the following 
tests:
-  Less than $10,000 in the past year when aggregated for the immediate family and the
-  Amount will not be affected by the outcome of the research.
3)
No-
Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or 
licensing agreement. 
4)
No-
Board or executive relationship (e.g., director, officer, partner, or trustee) related to the research, regardless 
of compensation. 
List the Name(s) of Study Team Members who have Disclosable Financial Interests  
(Including Lead Researcher, Co-Researchers, Research Personnel and, if applicable, Faculty Sponsor) 
First Name
Last Name
Email
Phone
SUBJECT POPULATION:
Age range of subject population - Youngest: 1 - Oldest: 65
STATUS
Approval Type:
All Training Complete 
Date:
Approval Date:
B-Expedited
9/17/2020
3/5/2021
Date Research Can Begin:
Expiration Date:
3/5/2021
3/5/2022
By clicking the "I agree" button on the electronic signature page in ORahs, I certify in my capacity as the role of the 
investigator or faculty advisor that this study will be conducted in the manner described in the protocol and that the 
research team will adhere to the ethical and scientific standard for conducting human subjects research. All researchers 
on this project will complete the HS training requirements before this research commences as well as any individuals 
who interact with human subjects or have access to their identifiable data. I understand that I am ultimately responsible 
for the safe conduct of this project and I will notify the Human Subjects Committee immediately in the following 
instances:
       - A request for review and approval of all proposed modifications prior to implementation
       - Report of any problems, adverse events, or unanticipated complications that may put subjects at increased risk of   
            harm (e.g. mental or physical adverse events/reactions, breach of confidentiality)
       - Report any other problems associated with the conduct of this research (e.g. non-compliance)
I agree to comply with all copyright and record retention requirements designated by University of California, UCSB 
Human Subjects Committee, Federal and State governments, and other organizations/institutions associated with this 
research, including funding organizations and sponsors.
PROTOCOL SUBMISSION - ELECTRONIC SIGNATURE PAGE
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Do you plan to use human participants from any of the following populations?
No-Researcher's students
No-Researcher's subordinates
No-UCSB Students (18 years or 
older)
Yes-Adults (18 years or older)
No-Wards of the state
No-Prisoners
No-Institutionalized
No-Pregnant
No-Other
Describe the proposed subject population, including gender, race, ethnicity, language, and literacy.
We plan to recruit 48 family dyads (48 parents and 48 children) for this proposed study. One parent and one young child 
with autism per family will participate. Attempts will be made to recruit families across the United States that represent 
the racial/ethnic diversity of the country.  All families will be English-speaking. Parents must be able to read and write.
Identify any criteria for subject inclusion or exclusion. If inclusion/exclusion criteria are based on gender, race, or 
ethnicity, explain rationale for restrictions.
Inclusion Criteria: 
Child participants must (a) be between the ages of 1.0 and 5.0 years (12 and 60 months), (b) have an existing diagnosis 
of autism spectrum disorder, and (c) have parent endorsements of significant language delay as a major area of concern. 
Parent participants must be willing and able to read, complete intake and follow-up assessments, have regular access to 
an internet connected smartphone or tablet, complete the eight weekly PRT lessons, record and submit parent-child PRT 
videos, and review these videos on a weekly basis.
Exclusion Criteria: 
Children with co-occurring significant medical conditions, seizures, and mental health concerns will be excluded. 
Because all training materials will only be available in English for this initial trial, non-English speaking families will also 
be excluded.  Families without access to a smartphone or tablet that can run the app and record video and those who do 
not have access to an internet connection will also be excluded. 
Check which of the following recruitment tools will be used to recruit potential participants. Upload copies of recruitment 
materials (e.g. scripts, advertisements, flyers, letters) to the Attachments section:
Yes-Minors
No-SONA Pool
Yes-Website/Social Media Outlets
Yes-Email/Electronic Mailing List
Yes-Flyers or brochures
No-Letters
No-TV, radio, or print advertisements
Yes-Verbal (personal solicitation)
Anticipated number of subjects? 96
Yes-Cognitively impaired
RECRUITMENT METHOD:
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Describe the process for how you will be recruiting potential participants. Include a description of how contact 
information will be obtained
Families will be recruited nationwide using targeted social media advertisements and postings on online forums 
(autism support forums, military family listservs), email announcements, social media groups (local Autism Society 
of America/Autism Speaks chapters), the UCSB Koegel Autism Center website, and word of mouth. See 
attachment section for the recruitment ad. Interested families who respond to our recruitment ad will be scheduled 
for a video conference or phone-based consent session.
No-Telephone scripts
No-Other
LOCATION:
Select all study sites where the research will be conducted:
Yes-UCSB
No-Schools (public and private)
No-International
No-Other university campus
No-Private Institutions or locations
Yes-Other location (e.g. homes, online)
UCSB:
Research data will be analyzed at the UCSB Koegel Autism Center, housed with the Gevirtz Graduate School of 
Education at UC Santa Barbara. 
Other location (e.g. homes, online):
Parents will use the project's smartphone application in their home in towns and cities across the United States. 
Entered data and video recordings will be sent to UCSB for analysis.
PURPOSE: Provide a brief description of the purpose of the project in lay terms, including the specific study objectives, 
rationale, and hypotheses.
The majority of families in the United States do not have access to adequate autism intervention services. The 
development of smartphone apps designed to train parents in these strategies may help. The objective of this 
proposed clinical translational research project is to develop and evaluate self-directed smartphone app-based 
parent education programs designed to facilitate mass dissemination of a well-established, evidence-based autism 
treatment (Pivotal Response Treatment).  It is hypothesized that one of the apps, which will feature video self-
modeling/ parent self-scoring components, will yield superior outcomes over the other app without these 
components.  
SPECIFIC AIMS
1.
Develop PRT smart-phone applications that combine existing instructional lessons and videos with video 
capture and video self-modeling/fidelity analysis functionality.
2.
Conduct a pilot randomized clinical trial to assess the feasibility, utility, and preliminary outcome efficacy of 
these two app-based PRT programs as promising mechanisms to disseminate evidence-based autism 
intervention to the general public.
3.
Determine if a PRT app with video self-modeling/fidelity self-scoring and individualized feedback 
components yields superior gains in parent fidelity and child outcomes over the basic PRT app without this 
functionality as a means to evaluate mechanisms underlying rapid learning and mastery of PRT strategies.
METHODS:
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No-Medical equipment
No-Physical tasks
No-Biological specimens
No-Genetic testing
Describe your study procedures in detail of how the research will be conducted. Include information about all study 
procedures (e.g. all interventions/interactions with subjects, data collection procedures) and follow-up procedures. 
Include the number, duration, and frequency of sessions to be completed with the participants. Upload copies of all study 
materials to the Attachments tab.
Overview
 
This proposed project aims to conduct a pilot randomized clinical trial to investigate the feasibility, utility, and 
preliminary efficacy of two versions of a self-directed, smartphone app-based parent education program to teach 
Pivotal Response Treatment to target core social communication vulnerabilities (social engagement and language 
use) in young children with autism. A PRT Manual is included in the attachments if HSC reviewers would like more 
information on this treatment model.  The programs will both focus on training parents in the well-established, 
evidence-based, manualized PRT early autism intervention, with the following manipulation:
 
1.
BASIC PRT PROGRAM: Parents complete 8 weekly training PRT training lessons within the app and then 
use the app to record and submit a 5-minute video administering the PRT intervention with their child doing 
PRT after each lesson. Parents will then watch their video performance, but they will not score their 
own performance or receive individualized feedback based on this performance.
2.
ADAPTIVE PRT PROGRAM: Parents complete 8 weekly training PRT training lessons within the app and 
then use the app to record and submit a 5-minute video administering the PRT intervention with their child 
doing PRT after each lesson. Parents will then review their video and self-score their PRT 
performance using a built-in fidelity scoring feature within the app.  At the end of scoring, the 
program will indicate areas of strength/weakness and provide feedback to improve their future PRT 
performance. A depiction of a PRT lesson and the app are in the attachment section.
 
This adaptive program is intended to remedy identified shortcomings of standard self-directed training programs 
with the introduction of video self-modeling/individualized instructional components that allow parents to (a) 
Does this project involve active deception? Active deception occurs when an investigator gives false information to 
subjects or intentionally misleads them about some key aspect of the research.
-No
Check which of the following biomedical procedures you plan to use: N/A
No-Physiological Intervention
No-Other
PROCEDURES:
Does this project involve incomplete disclosure? Incomplete disclosure occurs when an investigator withholds 
information about the specific purpose, nature, or other aspect of the research.
-No
Check which of the following data collection tools and/or methods you plan to use: 
Yes-Questionnaires/surveys
No-Focus groups
No-Observation
No-Audio recording
No-Photography
Yes-Video recording
Yes-Personally identiable info
No-Identifiable health info
No-School records
No-Interviews
No-Other
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regularly record and review their own parent-child treatment videos, (b) self-score their performance for PRT 
fidelity of implementation, and (c) access an adaptive curriculum of lessons based on identified fidelity 
shortcomings or parent-selected review topics/questions.
 
Type of Clinical Trial
 
This proposed project will utilize a double-blind randomized clinical trial design to compare the two PRT mobile 
applications on parent and child outcome measures. Parents and researchers will both be blinded to the PRT app 
condition of each family.
 
Research Partners
Our research team will be partnering with Novacoast, Inc., a Santa Barbara software company specializing in 
secure, cloud-based software-as-a-service solutions. We will combine our existing online PRT curriculum with their 
encrypted video upload and fidelity coding software into a single user-friendly smartphone/tablet application. 
Videos that are uploaded by participant families are automatically uploaded to secure Box cloud folders.
 
Procedure
After completing informed consent, parents complete an initial online battery of intake assessments (see measures
below). These online surveys are completed through a provided link to the online test companies' secure, 
encrypted testing website, which the study researchers can later access using a username and password Parents 
will also complete demographic questionnaires through an in-app link to a secure UCSB Qualtrics form. Personally 
Identifiable Health Information will include parent names, child names, child autism and co-occuring disorder 
diagnoses, email, phone, zip code, city, and state.  Families will be randomly assigned to adaptive or standard 
(control) PRT application groups for the 8 week intervention period.  Parents will be unaware of group assignment 
and will be asked to video record and upload a weekly 5-minute parent-child PRT session after each lesson. 
Research assistants (also masked to participant study condition) will use Noldus Observer coding software to 
score PRT fidelity of implementation (Primary Outcome) and child social communication behaviors (Secondary 
Outcomes): prompted and unprompted words, eye contact, and directed positive affect for each participant 
family¶s submitted videos (intake, after PRT lessons 1-8, and at follow-up 2 months after the final lesson). Online 
child development surveys (Secondary Outcomes) will also be administered at intake and follow-up (2 months 
after completion of the last PRT lesson).
 
Pivotal Response Treatment is an evidence-based autism intervention that combines motivational strategies and 
behavioral principles into a single comprehensive model (Gengoux et al, 2019; Verschuur et al, 2014).  It 
leverages child selected/preferred activities, task variation, clear learning prompts, contingent reinforcement of 
language attempts, logically related reinforcers, and a combination of mastered and new learning tasks to improve 
child language use and social engagement.  It is a play-based approach that is delivered in natural environments 
and emphasizes parent education (Verschuur, Huskens, & Didden, 2019). A PRT manual and fidelity scoring guide
are included in the attachment section.
 
The app-based PRT parent education program will consist of eight weekly 20-minute lessons. Each module will be 
entirely self-guided and progressively build upon skills learned in prior lessons. All informational slides will be 
accompanied by video examples to model proper use of PRT strategies. Brief multiple-choice quizzes and self-
assessments will also be incorporated to assess comprehension of the material. Parents will be encouraged to 
incorporate treatment strategies into their daily routines, interactions, and play activities on a regular basis. The 
planned app format is provided in the following table:
 
App Format & Sequence
Title Page
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Welcome splash screen
Program Overview, Consent for Research 
Provides a description of the app, the nature of the research, and provides the informed consent form. Also 
provides messaging link to ask questions to the research team or schedule a phone conversation prior to 
consenting.
Registration Page
Participants are asked to complete demographic questionnaires and are sent links to complete online intake 
assessments.
Tutorial of App 
Participants are provided with a brief video and visual tutorial of the app format so that they know what to expect 
and how to navigate through each lesson (Lesson, Video Capture, Review Sequence)
Lesson Format (20 mins)

Intro Video

Overview Slide

Narrated Content Slides

Demonstration Videos

Additional Narrated Content Slides

Additional Demonstration Videos

Comprehension Check with Multiple Choice Items

Summary Slide
Video Capture (5 mins)
 

Video capture tutorial with visuals for positioning the shot, capturing faces and activity

5-minute video capture of parent & child doing PRT

Video check/confirmation questions (parent & child both on screen, child not disruptive)
Video Review (10-15 mins; can be done immediately after capture or saved for a later time)
 

Tutorial on scoring PRT fidelity (adaptive apt only)

Replay of video

During video, parents will pause after each PRT trial, score for presence/absence of each PRT component 
(adaptive apt only)

At the end, the program will provide a performance summary with percent use of each treatment 
component (adaptive apt only)

The app will offer a link to trouble-shooting guidance/frequently asked questions
 
 
The content of the eight PRT lessons is summarized below:
Summary of the Eight App-Based PRT Lessons
The ABCs 
of PRT
An overview of PRT and its underlying behavioral and motivational strategies.This lesson focuses on 
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understanding the antecedent, behavior, consequence sequence of PRT learning opportunities and briefly 
describes all components
Child Choice & Task Variation
The concept of following the child¶s lead, varying the activity, and using their preferred activities and interests as 
the focus for PRT learning opportunities
Child Attention & Clear Opportunities
The importance of obtaining the child¶s attention prior to delivering a clear, simple learning prompt 
Contingency & Reinforced Attempts
The concept of immediately and contingently reinforcing any reasonable effort (not just perfect responses) to a 
prompted language attempt.
Natural Reinforcement
Use of logically related, natural reinforcers that are directly related to the child¶s verbal response.
Maintenance & Acquisition Tasks
A blend of easy, previously or nearly mastered learning opportunities to maximize motivation with more 
challenging, new concepts to promote more complex language acquisition
Social Activities & Reinforcement
Using social activities based on existing child interests to increase social motivation and engagement over time
Summary and Frequently Asked Questions
Reviews common questions and concerns raised by parents enrolled in PRT trials. Addresses strategies to 
respond to a lack of child responsiveness, slower than expected language development, and the presence of 
behavioral challenges. 
 
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Data Collection: Parent-Child Video Probes. At intake, parents will be instructed to submit a 5-minute video of a 
parent-child interaction using a child¶s preferred toys and activities. Parents are asked to play with their child while 
attempting to elicit as much social engagement and communication as possible.  After completing each online 
PRT lesson, parents will be instructed to submit a 5-minute video capturing their use of PRT strategies with their 
child, again using preferred toys and activities. Videos will be recorded and uploaded through the smartphone app. 
Because the program is designed to be an autonomous training program, families will not receive feedback on 
their performance from our research team. Parents in the standard PRT app condition will then watch their own 
video. Parents in the adaptive condition will be asked to watch their own video and score their own PRT fidelity 
using the app¶s built in scoring functionality. Specifically, parents will be instructed to pause the video after each 
PRT learning opportunity and tap buttons to indicate the presence or absence of core PRT components (see 
below). This video self-modeling exercise will allow parents to reflect on their own progress and serve as a guide 
to identify areas for future practice. In both conditions, within app upload of each weekly video is required in order 
to unlock access to the next lesson in the online PRT curriculum. 
Data Collection: Standardized Assessments. At intake, parents will also complete digital versions of 
standardized survey measures (secondary outcome measures described in the study variable section below) 
through emailed weblinks to testing company secure, encrypted websites. Assessments will be re-administered 2-
3 months after completion of the trial (and 4-5 months from the intake timepoint), allowing families to provide 
additional PRT intervention on an independent basis for 2-3 additional months.
STUDY VARIABLES
Parent Fidelity of Implementation Data (Primary Outcome). Video submissions will be independently coded by 
trained research assistants using Noldus Observer XT software to monitor improvements in parent Fidelity of 
Implementation (FOI) over the course of the program. Each learning opportunity will be scored on a trial by trial 
basis. Parents must demonstrate each PRT component (described below) in 80% of trials to meet FOI:
Behavioral Coding: Fidelity of Implementation
Child Attention
The parent must have the child¶s attention (on the stimulus or the parent) prior to presenting an opportunity.
Clear Opportunity
The parent¶s question/instruction/opportunity for the child to respond must be clear and appropriate to the task.
Child Choice
The parent should follow the child¶s choice with tasks and activities. However, the parent must always assume 
control should the child engage in dangerous (e.g. self-injury) or inappropriate (e.g. destroying property) activities. 
If child is not showing interest in the current task, parent should attempt to change the activity.
Task Variation
The parent must vary the activities/prompts used across the PRT session probe.
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Contingency
The parent must provide reinforcement contingent upon child¶s language attempt. That is, the parent¶behavioral 
response (i.e. giving the child a toy) must be dependent upon the child¶s verbal response (i.e. saying ³toy´
 
Natural Reinforcement
The parent must provide reinforcement that is directly and logically related to the child verbal request (e.g. the toy 
or activity being requested). Use of non-related reinforcement (stickers, edibles) is inappropriate
 
 
Reinforced Attempts
The parent should reinforce any goal-directed attempt to respond to questions, instructions, or opportunities. 
Although an attempt does not necessarily need to be correct, it has to be reasonable.
Maintenance & Acquisition Tasks
The parent should provide a combination of easy and more challenging task prompts
 
Child Social Communication Behaviors. Videos will be coded for the following child social communicative 
behaviors: vocalizations, eye contact, and positive affect. These behaviors were selected due to prior research 
indicating that these social communication skills are particularly important for development and may improve 
following PRT intervention (Bradshaw, Koegel, Koegel, 2017; Koegel, Vernon, Koegel, 2009; Vernon, Koegel, 
Dauterman & Stolen, 2012). Interrater reliability, and kappa estimates will be calculated to ensure consistent 
coding across research assistants.  Video segments in which the child is off-screen/blocked by a parent will be 
eluded from analysis.

Child Vocalizations are an indicator of attempts to use verbal communication and are defined as any 
verbal communication attempt that includes both intelligible words and directed word-attempts and 
vocalizations. This variable will be divided into the subcategories of prompted vocalizations (i.e. responses 
to a parent¶s verbal prompt) and unprompted vocalizations (i.e. spontaneous use of language without 
parent prompts). Undirected, scripted, and self-stimulatory vocalizations will be coded separately.

Child Eye Contact is a measure of social attention and engagement and is defined as the child looking 
toward the parent¶s eyes. 

Child Positive Affect is another measure of social attention and engagement within each session and is 
defined as smiling or laughing. It will be coded on a continuous basis.
Standardized Survey Measures. Digital versions of the following survey measures will be used for baseline 
participant characterization purposes in both phases.  In Phase 2, these measures will also be administered at a 
6-month follow-up time-point to obtain preliminary child outcome information. See attachment section to view 
these scales.

Social Responsiveness Scale, Second Edition (SRS-2; Constantino & Gruber, 2007). The SRS-2 is a 
caregiver-completed measure of a child¶s autism symptom severity. Parents will complete a digital version 
of the Toddler SRS-2.

Vineland Adaptive Behavior Scales, Third Edition (Sparrow, et al, 2016). The Vineland-III is a caregiver-
completed measure of adaptive functioning in children.Parents will complete digital versions of the 
Communication and Socialization domains of the Vineland-III Parent/Caregiver Rating Form.
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
MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Fenson et al., 
2000). The MacArthur-Bates CDI is a caregiver-reported measure of child expressive vocabulary use. 
Parents will complete a digital version of the CDI to obtain information on reported word usage and 
understanding. 
 
Parent App Use Data: The amount of time that parents spend using the PRT apps (i.e. engaged in new lessons 
or reviewing old lessons), along with latency between completed lessons will be analyzed as potential predictors of 
outcome. 
 
Parent Perceptions of Acceptability & Effectiveness Data. Feedback information will be obtained to assess 
parents¶satisfaction with the program, confidence in their therapeutic skills, and perceptions of child behavior 
change. parents in both phases will be asked to complete an in-app exit survey.  This survey will consist of both 
quantitative and qualitative elements.  They will first be asked to respond to a variety of statements using a scale 
of 0 (Strongly Disagree) to 5 (Strongly Agree). Items assessed for in this measure will include statements such as: 
³Over the course of the program, I have seen my child¶s language skills improve,´
³Over the course of the program, I have seen my child¶s social engagement improve,´
³I have a clear understanding of Pivotal Response Treatment component of BBBBBBBBB´
³I would recommend the course to another family.´
Parents will also be asked to provide written feedback on their experience of the course and suggestions for 
improvement. This information will help identify potential barriers to program completion and will be used to modify 
the program at the end of both phases: 
1.
In your opinion, what were the most positive aspects of the program?
2.
In your opinion, what were the most negative aspects of the program?
3.
Each weekly lesson had informational slides, videos, and quizzes.What did you think about the format of 
the weekly lessons? Would you have liked to see more or less of any of these components?
4.
What else could we have added to the lessons to make a concept clearer or easier to understand?
5.
What are your thoughts about the time requirements and pacing for this program? Would you have liked a 
shorter or longer program? Would you have liked more or less detailed lessons?
6.
What was your experience recording and uploading videos with your child?
7.
What was your experience reviewing your videos and scoring the PRT concepts?
8.
Do you have any suggestions for improving the video upload or review process?
Data Storage and Reporting: Data will be stored on encrypted folders on Box or on REDCap, which is a secure 
research database software program. The proposed trial will be registered with clinicaltrials.gov.  As part of the 
informed consent process, participants will consent to allow their deidentified data (no videos) to be shared with 
National Database for Autism Research (NDAR). Dr. Vernon will hold primary responsibility for publication of the 
results of the study and will work closely with other research team members to ensure timely dissemination of 
findings. 
Will participants be compensated (money, course credit, any other incentive) for their participation?
-Yes
Describe the plan for compensation of the participant and prorating if an individual withdraws from the study. Will 
social security numbers be collected? If yes, please include in consent form.
Families will be compensated with $25 for completing all intake assessments and a preliminary parent-child 
interaction video, up to $40 for recording and uploading parent-child PRT videos after each of the eight lessons 
($5 per video), and $25 for re-completing assessment measures and a final parent-child PRT video 2-3 months 
after completing the final lesson, with total compensation of $90 per family.  Families who do not complete all 
research phases will be compensated for the phases they did complete (prorated compensation).  Families will be 
paid through secure electronic transfer (Paypal, Venmo).
No
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RISKS:
PSYCHOLOGICAL: Describe psychological risks (psychological damage, embarrassment, discomfort, forced 
awareness).
Risk:
While the vast majority of children find the motivational 
intervention highly enjoyable, a small percentage of 
participants may be momentarily frustrated when 
encouraged to use language to obtain desired items and 
activities.
Parents may become concerned, distressed, or anxious 
if they do not master the lessons as quickly as they 
anticipated, if their children do not respond to their 
playful intervention bids, and/or if their children do not 
make the progress parents anticipated in language or 
social engagement domains.
Safeguard:
These concerns constitute no more than minimal risk and 
are comparable to everyday experiences by families who 
seek out autism therapy.  The intervention (Pivotal 
Response Treatment) is designed to be socially engaging 
and motivational in nature. It does not require perfect 
language requests in order to reinforce child language with 
desired toys and actvities, tasks are varied frequently to 
ensure that motivation is maintained, and free access to 
activities is initially provided. Parents are encouraged to 
stop the session if the children are having particular 
difficulty on a given day. Participants can withdraw at any 
time without penalty.
For parents, the PRT app lessons will include 
troubleshooting and frequently asked question features 
designed to help parents learn and master missing 
intervention components.   The lessons will also normalize 
the experience of having children be slow to respond or 
make progress and will guide parents to additional 
strategies for further promoting language and other 
developmental gains. Fears of a lack of developmental 
progress would be present in parents even outside the 
context of this research project, while participation actually 
gives them actionable steps to improve their outcomes
PHYSICAL: Describe physical risk (injury, exposure to violence, medical equipment).
Risk:
None anticipated
Safeguard:
NA
CONFIDENTIALITY/PRIVACY: Describe how privacy will be protected and confidentiality will be maintained (invasion of 
privacy, breach of confidentiality, exposed to criminal or civil liability, loss of job/employability, mandatory reporting to 
outside entities)
Risk:
There is a slight risk of identifiable information being 
exposed. Parent PRT improvement data and feedback 
survey questions pertaining to app usability/suggestions 
for improvement will be shared with Novacoast to further 
revise the app.
Safeguard: Describe how privacy will be protected and 
confidentiality will be maintained. 
The informed consent process serves as the terms and 
conditions document for use of the app, outlining how their 
data can and cannot be used. Parents are informed that 
their de-identified usage data and feedback will be used to 
shared with Novacoast to improve the app. Novacoast is 
not permitted to use the usage data for marketing or other 
research purposes. All participant information/video will be 
encrypted by the app prior to upload and are stored on the 
encrypted Box folder or REDCap database owned and 
managed by UCSB. All researchers are HIPAA trained and 
informed of privacy procedures.
DATA STORAGE: Describe how and where data will be stored. Include the types of devices (e.g., computer, tablet, Cloud 
service storage, etc.) used to store the information and if the devices are encrypted and/or password protected.
Risk:
All participant information/video will be encrypted by the 
app prior to upload and stored on the encrypted Box 
folders. Participant videos will be stored indefinitely. 
However, participants may request that these videos be 
deleted at any time. Identifiable information (e.g. contact 
information) will be stored separately from research 
data. A code will be assigned to link the data back to the 
subjects. 
Safeguard: If identifiable data (i.e., information and/or 
biospecimens) will be collected, include the disposition (for 
example, if identifiers might be removed or retained, how 
the data will shared, stored, archived, etc.) NOTE: Consent 
form(s) must include the storage and disposition of the 
data.
All participant videos and identifying information will be 
stored on encrypted BOX or REDCap databases. All staff 
must complete HIPAA and Human Subjects training prior to 
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CONSENT PROCESS: Describe procedures for obtaining informed consent. Include who will be responsible for seeking 
consent, how, when, and where consent will be obtained. If research will involve a non-native speaking population or an 
international component, describe the investigator(s) linguistic proficiency and/or how the consent documents will be 
translated in the subject¶s native language. Describe the measures taken to ensure subjects are informed about the 
research and how the appropriateness of the consent process will adhere to cultural standards.
Select which of the following criteria applies to your project:
No-The principal risks are those associated with a breach of confidentiality concerning the subject's participation in 
the research AND the consent document is the only record linking the subject with the research.
Yes-The research presents no more than minimal risk and involves procedures that do not require written consent 
when they are performed outside of a research setting.
Select the consent process that you propose to use in this study as an alternative to written informed consent:
No-Oral Consent
Yes-Information Sheet
No-Other
No-The subjects are members of a distinct cultural group or community in which signing forms is not the norm.
-Yes
Are you requesting a waiver of written documentation? Consent forms must be signed unless a waiver of written 
documentation (i.e. physical signing of the consent form) is requested, justified and approved.
Waiver of Written Documentation
When families respond to recruitment advertisements expressing interest in participation, they will be scheduled for 
a consent video conference or phone session with a member of the UCSB research team. Prior to or during this 
meeting, they will be asked to download the smartphone app and follow along with the in-app written consent 
information. This information will also be emailed to them. Potential participants will first be presented with a brief 
summary of the project and a timeline.  Participants then have the option to continue to a hear more detailed 
informed consent information or decline participation.  After hearing about the project from a member of the UCSB 
research team and reading through the informed consent information, participants have the option to digitally sign 
the consent form, read through frequently asked questions, and ask the research team questions, or have additional 
time to think about it.
receiving data access.  Staff access to the server is 
restricted based on project roles and access privileges are 
reviewed quarterly.
AUTONOMY: Describe the risk to autonomy (incentives coercion, economic, use of own students/staff/friends):
Risk:
Financial incentives may coerce participants to enroll. 
Participants may fear their app usage data is being used 
by Novacoast for non-research purposes (marketing)
Safeguard:
Incentives are reasonable based on time involved ($25 for 
intake questionnaires and $5 per submitted parent-child 
video.  Parents are also receiving access to a highly 
effective autism intervention, so the cash incentive is 
unlikely to be the primary motivator for participation. 
Novacoast will not use the acquired data for purposes other 
than this research project.
OTHER: Describe any risks not listed above.
Risk:
None anticipated
Safeguard:
NA
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Child Assent and Parental Permission
Will you be requesting a waiver of assent for children aged 17 or younger?
-No
Will you be requesting a waiver of written parental or guardian permission?
-Yes
Which type of waiver applies to your project?
I am obtaining parental or guardian permission, but not 
collecting signed consent forms
Provide a substantive rationale for this request to waive written parental permission:
The study will be conducted completely online and participants will not meet in person with the research team; 
therefore, an electronic consent form with digital signature will be provided.
Select which of the following criteria applies to your project:
Yes-The research presents no more than minimal risk; it is not practicable to conduct the research without the 
waiver or alteration; waiving or altering the permission will not adversely affect the subjects¶rights and welfare; 
and pertinent information will be provided to the subjects later if appropriate
No-The research will be conducted by or subject to the approval of state or local governmental officials; the 
project is designed to examine (i) public benefit of service programs, ii) procedures for obtaining benefits or 
services under those programs; iii) possible changes in or alternatives to those programs or procedures; or iv) 
possible changes in methods or levels of payment for benefits or services under those programs AND it is not 
practicable to conduct the research without the waiver or alteration.
No-Written parental or guardian permission is not a reasonable requirement to protect the subjects (e.g. 
neglected or abused children) AND there are appropriate mechanisms for protecting the children who will 
participate as subjects in the research are substituted AND the waiver is not inconsistent with federal, state, or 
local law.
Waiver of Consent:
-No
Are you requesting an alteration or a full waiver of informed consent? If the consent process omits or alters one or more 
of the required elements (see 1-10 below) of informed consent, then a waiver of consent must be requested, justified and 
approved. -No
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Print Date: Thursday, April 22, 2021 9:35 AM

ELEMENTS OF INFORMED CONSENT
I
WR
NA
I
WR
NA
= Informed Consent
= Waiver Requested
= Not Applicable
Required Elements
X
1.
Investigator¶s name, phone number, & email address.
X
2.
A description of the nature & purpose of the study.
X
3.
Description of procedures to be used and the expected duration of the subject¶s participation.
X
4.
A statement describing the extent to which and how confidentiality of records identifying the 
subject will be maintained.
X
5.
A statement that identifiers might be removed from identifiable private information or identifiable 
biospecimens and after such removal, the information or biospecimens could be used in future 
research without additional informed consent (if applicable). OR, a statement that information or 
biospecimens, collected as part of this research, even if identifiers are removed, will not be used 
for future research studies.
X
6.
A description of any attendant discomforts & risks reasonably to be expected or (rarely) that 
there are no foreseeable risks.
X
7.
An explanation of any benefits to the subjects or society reasonably to be expected 
(payment/class credit is not considered a benefit).
X
8.
An offer to answer any questions concerning the study.
X
9.
An instruction that participation is entirely voluntary, & consent to participate may be withdrawn at
any time without prejudice.
X
10.
 Human Subjects Committee contact information.
Optional Elements:
X
11.
Approximate number of subjects involved in the study.
X
12.
Any payment, reward, or cost for participation. Include how payments or rewards will be prorated 
if the subject withdraws.
X
13.
If extra credit for a class is given, an explanation of the non-research alternative available to earn 
equivalent credit.
If applicable, make a selection from the below items
X
14.
Warning of UCSB¶s mandatory child abuse reporting for studies through which the Investigator 
might gain knowledge of child abuse.
X
15.
An instruction that either the investigator or the subject may terminate the subject¶s participation 
at any time.
X
16.
For any study involving more than minimal risk, which may result in injury, include the following 
standard language: If you are injured as a direct result of research procedures, you will receive 
reasonably necessary medical treatment at no cost. The University of California does not provide 
any other form of compensation for injury.
X
17.
The disclosure of any alternative procedures, drugs or devices that might be advantageous to the
subject; their relative risks & benefits.
X
18.
An explanation of any drug or device to be utilized, & any foreign substance to be administered.
X
19.
Identification of procedures, drugs, or devices that are experimental.
X
20.
A statement that the particular treatment or procedure may involve risks to the subject (or 
embryo or fetus if the subject is or may be, pregnant) which are currently unforeseeable.
Page 15 of 17
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X
21.
Consequences of a subject¶s decision to withdraw from the research and procedures for orderly 
termination of participation by the subject.
X
22.
A statement that significant new findings developed during the course of the research which may 
relate to the subject¶s willingness to continue participation will be provided to the subject.
X
23.
For any study which may result monetary gain for the researcher, add the following statement: 
The study investigator has a financial interest in this research and may benefit monetarily from 
this study. You may ask your investigator for more information on his or her interest.
X
24.
If samples will be taken for research and development purposes not related to the subject¶s 
treatment or condition, include the following standard language: Samples taken during this study 
may be used for research and development purposes not related to your treatment or condition. 
You will not have any property rights or ownership interest in products or data which may be 
derived from your samples.
X
25.
A statement whether clinically relevant research results, including individual research results, will 
be disclosed to subjects, and if so, under what conditions.
X
26.
For research involving biospecimens, whether the research will (if known) or might include whole 
genome sequencing.
X
27.
One or more study team members have been listed with a disclosable financial interest.
CONSENT FORMS:
Form Name
Form Type
Description
Parent Consent
Model Consent
Parent Permission
RISK/BENEFIT ANALYSIS: Activities involving human subjects can only be approved if the expected benefits outweigh 
the risks and activities do not pose any unnecessary risks to subjects.
BENEFITS: Describe benefits, if any, to the subjects, to the class of subjects, to society, and to advancement of 
knowledge. If there are no direct benefits anticipated for the subjects, please state as such. Do not include 
compensation as a benefit.
It is anticipated, though not guaranteed, that the participant children with ASD will exhibit increases in their use of 
appropriate social-communication skills. It is also anticipated that participant parents will acquire effective intervention 
skills. Disparities in access to services for children with ASD are an area of increasing concern for the field of autism 
research, and this study will examine whether an smartphone app-based intervention model can help to provide 
quality services to those who might not otherwise receive them. 
RISK-BENEFIT ANALYSIS: Explain why any risks to the study are reasonable in relation to the potential benefits to 
subjects and/or society.
There are minimal risks associated with participation in this study. The potential to improve treatment access and 
outcomes for many children with ASD represent substantial benefits. 
Page 16 of 17
Print Date: Thursday, April 22, 2021 9:35 AM

UPLOADED DOCUMENTS:
Document Type
File Name
Upload Date
Instrument
SRS-2 Preschool Form.pdf
7/10/2017
Instrument
Vineland Items.pdf
10/17/2018
Instrument
MCDI.pdf
10/17/2018
Instrument
PRT Fidelity Guide 2019.doc
12/18/2019
Recruitment
Recruitment Ad - PRT Smartphone App.docx
2/20/2020
Images
PRT App Sample Screenshots and Features.pdf
12/19/2019
Other
Week 2 Module.pdf
4/28/2017
Other
PRT Manual Final.pdf
12/18/2019
Scientific Merit Review
IRB Scientific Review Form - DoD PRT App Grant.pdf
3/9/2020
Progress Report:
Describe your experience with the use of human subjects in this project. Include how many subjects have been used, a 
summary of the research to date, and any other pertinent information (e.g. publications or presentations of this data)
Research activities to date have included recruiting and training study personnel, creating modules for the PRT 
application and coordinating with application developers, planning for recruitment, and preparing to create the 
online RedCap database to securely store PHI and questionnaire data. In response to the COVID-19 pandemic, all 
study coordination has occurred virtually. There have been no human subjects recruited or enrolled yet (anticipated
for later this year)
Have there been any complaints, complications, or unexpected outcomes?
-No
Has the research resulted in any publications or presentations within the last year?
-No
Page 17 of 17
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