Autism Access Link for Early Referral and Treatment Expansion
Conditions: Autism Spectrum Disorder
Sponsor: Oregon Health and Science University

 
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Minimal Risk Protocol: Autism ALERT 
 
1) 
Protocol Title 
Autism Access Link for Early Referral and Treatment 
2) 
Objectives 
Autism Access Link for Early Referral and Treatment [ALERT],  the  intervention  
proposed  in  this  application,  is  a  novel  state-wide  referral  and  case  management  
platform that PCPs can activate to ensure that a child with suspected Autism Spectrum Disorder 
(ASD) receives all necessary ASD diagnosis and treatment resources in a single referral, 
radically simplifying a complex diagnostic and treatment process. We hypothesize that Autism 
ALERT will have strong acceptability and high rates of use among primary care providers as 
well as among diverse low-income patients of children at risk for ASD, and that we will see 
higher rates of child ASD educational evaluations within six months, and shorter time between 
referral and ASD treatment,. 
3) 
Background 
Children  with  ASD  can  be  accurately  identified  as  early  as  two  years  old. Children 
identified early and placed promptly into comprehensive treatment models [CTMs] such as 
applied behavioral analysis programs, show improvements in language, IQ and adaptive 
functioning. Still, average age of ASD diagnosis in the US is around 4 years old, and is older for 
low-income and racial/ethnic minority children. Low-income and minority children are also 
less likely to be diagnosed with ASD, and are more likely to have severe features (e.g. comorbid 
intellectual disability). Although access to evidence-based ASD therapy is rapidly expanding, 
most children with ASD are not  treated  with  evidence-based  interventions,  and  minority  
children  use  Early  Intervention  and  CTM  therapies  at  the  lowest  rates.  Thus,  there  is  a  
strong  need  for  interventions  that  connect  low-income  and  minority children with existing 
services that they are eligible for and could access. Primary-care based screening for ASD and 
other developmental delays is increasing. As a result, more children with suspected ASD are 
identified and referred from primary care. However, unlike other conditions for which early 
identification and treatment are critical (e.g., hearing impairment, congenital metabolic 
disorders), there exist no statewide or national systems to ensure that children identified with 
ASD risk are promptly evaluated and treated. While  ASD  services     are     theoretically     
available for most children in the  US,  they  are  often  not  accessed,   leaving   a   critical   gap 
between identification of suspected   ASD   in   primary   care    and    access    to    ASD    
diagnostic    and    treatment services, particularly for low-income and minority children. 
Research by our team suggests that this gap exceeds 2 ½ years on average. However, our prior 
research has also shown that when PCPs help families connect with ASD services, ASD diagnosis 
and treatment is timelier, and timely diagnosis is associated with increased use of evidence-
based services. As a result, we propose a model statewide intervention to close the gap between 
identification of suspected ASD in safety-net (i.e., underserved setting) primary care clinics and 
use of diagnostic and treatment resources, for low-income and minority children.  
 
 

 
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4) 
Study Design  
We propose a pilot clustered interventional trial with two arms. Clinics in the 
intervention arm receive Autism ALERT plus an ASD screening intervention (START Autism), 
and clinics in the comparison intervention (control) arm receive only START Autism (no Autism 
ALERT). As this is  a  pilot  trial,  primary  outcomes  of  interest  are  feasibility  and  
acceptability.  We will additionally assess mechanism of outcome, preliminary efficacy, and 
protocol fidelity. Feasibility and acceptability will be assessed in intervention clinics. 
Mechanism of action and preliminary efficacy will be assessed by comparing intervention to 
control clinics. Fidelity is assessed in both arms. We will pilot test Autism ALERT in 6 safety-net 
primary care clinics in Oregon: 3 clinics will serve as intervention clinics, receiving both Autism 
ALERT and START Autism, and  3  clinics  will  serve  as  controls  receiving  START  Autism  
only.  Study arm will be assigned via coin-flip randomization of clinics, stratified for size and 
urbanicity, by a statistician who is not otherwise part of the study team. 
In 2023 we received new funding from CareOregon to expand the project.   As a result, 
this pilot study will be expanded to all of Portland-metro area. It will no longer include a  
control arm. Participants will be recruited off of Autism clinic waiting lists in the PDX metro 
area, and will be enrolled into the study to receive family navigation services from our partners 
at Help Me Grow.  
 
5) 
Study Population 
a) Number of Subjects 
The three subject groups include clinics, child/parent dyads, and providers. We seek to 
enroll 7 safety net primary care practices. 70  child/parent  dyads  will  participate  in  this  
study  (20–baseline  condition,  25–intervention,  25–control). We estimate that 30 providers will 
participate in this study (15–intervention; 15–control).  The number of participants per site will 
depend on the size of the participating clinics.  
Per the expansion to all of Portland-metro area, we estimate that there will be around 
300 children enrolled in the next 3 years.  
 
b) Inclusion and Exclusion Criteria 
 
There are different eligibility requirements for clinics, children/parents, and providers. 
To meet eligibility criteria, participating clinics must have >30% Medicaid enrollees or 
uninsured patients. Family medicine clinics must have >30% children. The study will be initially 
offered to safety-net primary care practices in 3 Oregon counties.  We seek to enroll 6 clinics; if 
more than 6 clinics initially express interest, we will randomly choose 6 interested clinics, 
reserving at least two spots for non-metropolitan clinics.  If fewer than 6 express interest, we 
will open recruitment to an additional two counties. Additional counties will be considered if 
recruitment is inadequate.   
 
Child/parent  dyads  are  eligible  for  inclusion  when  the  child’s  PCP  suspects  the  
child  has  ASD.  This can be for any reason, including the child having a high-risk ASD screen, 
or clinical concern.  Children with prior ASD diagnoses or prior history of diagnostic evaluation 
for ASD are excluded. Enrolled children must be between age 12 and 54 months at enrollment 
to ensure EI/ECSE eligibility. 

 
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Provider subjects must  be  pediatric  primary  care  providers  (e.g.,  physician,  nurse  
practitioner,  physician  assistant)  licensed  in  Oregon, and must see children age 1-5 for well-
child care. Subspecialists are excluded. 
 
For the expansion, any child aged 1-5 years old on an Autism clinic waiting list at OHSU, 
Randall Children’s Hospital, Providence Child Development Institute, Mindsights, or The 
Children’s Program, or a referral from an Autism ALERT trained provider is eligible to join the 
study, if they have not previously been medically diagnosed with Autism.  
 
c) Vulnerable Populations 
       This study will include children under 7, as described in the inclusion criteria. The study 
may also incidentally include pregnant women, as there are no exclusion criteria for the parent 
in a child/parent dyad.   However, pregnancy is not a focus of the study.    We will not obtain 
information about parent pregnancy status as part of this research. The study excludes 
neonates, decisionally impaired adults, and prisoners.   
 
d) Setting 
Autism ALERT services will be administered through Help Me Grow (HMG) Oregon.  HMG  is  
a  national  model  system  promoting  optimal  early  childhood  development  via  cross-system 
connectivity. Universal HMG components include: a centralized telephone access point to help 
families and  professionals  connect  children  with  community-based  programs  and  services;  
family  and  community  outreach  to  advance  developmental  promotion  and  grow  
awareness  of  developmental  resources;  healthcare  provider  outreach  to  support  early  
detection  and  intervention;  and  data  collection  to  support  program  evaluation,  bolster  
advocacy,  and  guide  quality  improvement.   
In Oregon, HMG is part of the Swindells Resource Center at Providence Portland Medical 
Center. Swindells is a statewide disability support organization with offices in Portland, the 
Columbia River Valley, and Southern Oregon.  In  addition  to  HMG,  Swindells  has  a  family  
navigation  program  for  children  with  developmental  disabilities with experienced family 
navigator staff. Swindells is located in the same building as Oregon Pediatric Society, which will 
oversee the comparison intervention. Thus, colocation of Autism ALERT and HMG within 
Swindells places Autism ALERT and its staff in a supportive environment that is rich in 
information about childhood disability, and which is poised for statewide dissemination. The 
study Navigators are employed by HMG and the Swindells Resource Center.  Swindells staff 
involved in the project are considered part of the study team and have submitted (or will 
submit in the future, in the case of the navigators as they have not yet been hired) required 
training documents.  An IAA is being requested with Providence.    
 
Additional data will be collected through a chart review performed by administrators at 
participating clinics. The clinic administrators will be considered engaged in research, and will 
complete and Individual Investigator Agreement (IIA), in addition to completing an IRB and 
study procedures training from the study team. The administrator will be compensated at a rate 
of $40 per hour at 6 sites and at a flat rate of $200 at one site that would not allow hourly 
payment.  
This study is being designed with input from Emily Feinberg, an advisor and collaborating 
researcher from Boston Medical Center. Dr. Feinberg will interact with the study team and may 
provide training to the Navigators, who are part of the study team, but she will not interact with 

 
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or interview subjects, she will not be involved in the consent process, and she will never have 
access to identifiable private research data.  
The CareOregon funding will provide a means of expansion to help families navigate Autism 
diagnosis services in all of Portland-metro area. While navigation services will still be provided 
through Help Me Grow, the service areas will now include all of Portland-metro. Specifically, 
any child on an autism clinic waitlist, or any child who has received an autism clinic referral 
can access navigation services through our program.  
 
e) Recruitment Methods 
The study has a clinic-based recruitment strategy.  In order to assure that the intervention 
addresses the needs of diverse children who are underserved in autism care, study inclusion 
criteria mandate that participating clinics have at least 50% Medicaid or uninsured patients.  In 
addition, to make sure sample size is adequate, Family Medicine clinics must have at least 30% 
children.   Since one of the study’s goals is to ultimately reduce racial and ethnic disparities in 
the early identification of ASD, we will strive to attain a racially and ethnically diverse family 
sample by specifically approaching clinics that serve a diverse patient base, including recruiting 
clinics in rural areas. Autism ALERT will initially be offered to all Oregon primary care clinics 
meeting inclusion criteria in selected counties.  We seek to enroll 6 clinics; if more than 6 clinics 
initially express interest, we will randomly choose 6 interested clinics, reserving at least two 
spots for non-urban clinics.  If fewer than 6 express interest, we will open recruitment to 
additional counties. In this way, we hope to recruit a sample that would be representative of 
primary care clinics who will ultimately participate in a larger-scale study. 
Clinics will be recruited to the study with the help of the Oregon Pediatric Society. They will 
be approached initially via an approved recruitment email (see “Autism ALERT Email 
Templates”). The recruitment process will include a training session for all clinic staff, at which 
initial provider surveys and patient study packets will be distributed.  
Families will initially receive a study packet from their provider at the time of the referral.  
The packet will contain a children’s book, information about autism, an Early Intervention 
Referral Form, and a Study Interest Form.  Aside from the study interest form and the phone 
scripts that are used for screening there are no other recruitment materials (e.g., emails, flyers) 
for family participants at this time. They will learn about the study first from the study interest 
form. The Study Interest Form will include some general information about the study, as well as 
a HIPAA authorization allowing disclosure of family contact information and some health 
information to the study team. The parent will sign the interest form, allowing the clinic to pass 
the family’s contact information to the Navigator team. Navigators will then reach out to the 
family to complete the online consent process, or phone consent process as necessary (see more 
information below).  Please see Family Consent Form attachments.  Family enrollment will be 
incentivized with a children’s book and $50 stipend per survey completed for both 
experimental and control groups. Provider participants may receive Continuing Medical 
Education credits and/or Part IV Maintenance of Certification credits, if desired, as part of their 
participation in this study. Clinics may also be entered into a raffle to incentivize their patients’ 
referral to the study, based on whether they refer any patients to the study in a given time 
period. The raffle incentive will be a gift or food basket costing less than $100.   Control arm 
clinics will also be given a box of chocolate on Valentine’s day to further increase enrollment as 
enrollment is lagging in that arm.  

 
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For clinics in the OHSU system, referrals to the Autism diagnostic clinic will also be 
monitored for potential study recruitment. The diagnostic clinic staff will provide a list of MRNs 
of patients referred to the OHSU Autism Clinic, which will be transmitted via secure OHSU 
emails to the referring primary care provider  and study team for inclusion in the study. Data 
will be transmitted as a list of MRNs, which the provider can use EPIC to identify and consider. 
If the provider gives permission, the study team will directly contact the family.  No PHI will 
leave OHSU.   
For the expansion, we will be recruiting participants through Autism clinic waitlists. We 
already have access to Providence and OHSU system waitlists as study staff are at both sites. We 
are requesting a HIPAA waiver to access patient contact information for all sites.  We will 
contact participants off the waitlist to enroll in the study. We will also be providing Autism 
screening training to providers and clinics in Portland-metro who express interest. These 
providers will also be receiving CME credits. These providers can then refer children they 
suspect may have Autism to our project, in addition to sending in a referral to their nearest 
Autism clinic.  
We will be contacting autism clinics to see if  they would like to offer Autism ALERT 
enrollment to families from their site; if so a HIPAA Waiver will be completed for that site.  If a 
family is intended to be recruited off the autism clinic waitlist, we will also be sending them an 
advance letter through either email or mail 2 weeks before proceeding to call them for 
enrollment. If possible, we will also attempt to contact parents through their Electronic Health 
Record portal such as MyChart.  They will be instructed to contact the study team if they would 
like to opt-out via email, text, or phone. 
 
f) Consent Process 
There are two informed consent processes in this study: one for primary care providers, and 
one for children and their parents.  
 
Providers:  
For providers, an IRB-approved information sheet providing all elements of an informed 
consent will be provided by the study team at the clinic-based training. Providers will be 
given the option to opt out of the project entirely both initially and subsequently at any 
point. They do not have to offer the study intervention (Autism ALERT) to any family for 
whom it may seem inappropriate. Providers will sign a line at the end of the information 
sheet to indicate their consent; an electronic consent form will also be available for 
providers who miss the initial project meeting but who still want to participate.   
 
Families:  
The consent process for families (in the intervention and control groups) was different 
than that for primary care providers. Families for whom ASD is suspected will be handed a 
study interest form by their PCP. The PCP will ask if they are interested in learning more 
about the study. If so, they   will indicate their interest by completing a study interest form. 
This study interest form will serve as authorization to allow the PCP to release information 
to the researchers for recruitment purposes. This signed interest form signifies study 
interest but is not a consent for the study. Interested parents will then be contacted by the 
study team via phone, text or email, to secure electronic signed consent or verbal consent. 

 
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Text messaging, using the secure Twilio app hosted by OHSU, will be utilized for scheduling 
phone calls. Text messaging will not be used to obtain consent but will be used to schedule a 
phone appointment to obtain consent. After consenting, the family may also choose to 
receive text messages from the navigator or study team with updates, reminders, or other 
scheduling requests.  
 
Electronic consent: Families will sign consent electronically through a form built in 
Research Electronic Data Capture (REDCap). The software allows consent forms to be 
emailed directly to the email address that the participant provides upon signing the 
Study Interest Form. Per OHSU OCTRI requirements, participants will click a radio-box 
for yes or no, and if yes is selected, will enter their first and last name. This will be used 
in conjunction with the timestamp on the REDCap form to confirm consent to the study. 
In most cases, participants will provide electronic consent while on the phone with a 
Navigator, who will be able to confirm their identity through phone, email, and signature 
congruency.   
Verbal Consent over the Phone: For families lacking internet access, a verbal consent 
via telephone will be provided in lieu of electronic signed consent.  For these families we 
have requested a HIPAA waiver/alteration. 
 
Family consent for Expansion: Children who are referred from their primary care 
providers will follow the same consent process as the pilot project, wherein a team member will 
reach out to them to receive electronic or verbal consent. We will request a HIPAA waiver to 
reach out to children on the OHSU CDRC, Providence Health Systems, and Legacy Health, 
Mindsights, and The Children’s Program waitlists. This will allow us to contact families off the 
waitlist and ensure all families have the option of receiving a family navigator, as it is 
impractical to recruit every single primary care clinic in the Portland metro area to provide 
referrals to us.  
 
 In the pilot study - Medical record review:  One member of the administrative staff of 
each participating clinic will be engaged in research, and will complete an IIA in addition to 
a specialized training on IRB and study procedures (see attachment).  (This medical record 
review process will not be continued in the expansion) They will perform medical record 
review for each clinic to ascertain autism and developmental screening rates throughout the 
project.  This person will have access to patient medical records as part of their usual work.  
The administrator will transmit de-identified medical record review information on PCP 
screening rates and referral patterns using the Medical Chart Review Tool to the study team 
via fax or secure email..  For this portion of the research, no identifiable patient information 
will be collected or relayed to the study team.  Since no individual identifiers will be 
collected or transmitted, this portion of the study would not be considered human subjects 
research.  It is not possible to obtain parent consent for this variety of work since thousands 
of children would be seen in pediatric practices during this time period (in our prior 
research study of similar design, it was >2000 visits over 6 months).  Obtaining consent from 
this volume of patients in the pediatric office setting would make this project impossible to 
conduct, since no community pediatric practices would agree to participate.   It is also 

 
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unnecessary because we are not getting any information that would readily identify 
individuals based on this chart data we obtain from the clinics.  
The research team will repeatedly emphasize to community providers and study team 
members that participation is optional, and that families should not be coerced to 
participate. Given that many families of children at risk for autism have low literacy and/or 
limited English proficiency, all study materials including consent documents will be 
available at a 6th grade reading level in English and Spanish, and a study research assistant 
and family navigator will speak both languages fluently. Families speaking languages other 
than Spanish or English cannot enroll in the study but can be referred to Swindell’s existing 
family navigation services (not part of the research study) if PCPs choose.   We cannot enroll 
non-English/non-Spanish speakers in the study, because from a scientific standpoint their 
resource use would be quite different.  In addition, the low numbers of enrollees in this 
group might create imbalances in the intervention and control arms that would make data 
interpretation challenging.   
Pregnant women are only enrolled incidentally as part of the general parent study 
population; no study procedures will entail any risk to pregnant women or their fetuses. 
This project will not enroll human fetuses, neonates, or prisoners. 
 
Modifications to the Consent Process  
       For the pilot, It should be noted that primary care sites are only obtaining authorization to 
share family contact information with the study team and not directly obtaining informed 
consent.  Given the realities of community primary care (e.g., 15 to 20 minutes for an entire well 
child check), it is not possible for community primary care providers to obtain informed 
consent.  In addition, doing so would require the study team to engage 30 community primary 
care providers in research, which it is unlikely that they would be consistently willing to do.   
Whenever possible, signed consent and authorization will be obtained electronically. However, 
we are requesting a waiver of consent documentation for families that cannot access the 
internet. This will allow us to obtain consent and authorization verbally for those individuals 
when it is not practicable to get signed consent and authorization. We have also submitted the 
necessary HIPAA documentation to allow for this verbal consent and authorization.  Since 
families will be located all over the state of Oregon it will not be possible to mail and mail back 
a signed consent form in a timely way, and this delay might contaminate time-sensitive study 
outcomes.  Therefore obtaining a signed consent in these cases is not possible.   
For the expansion, we will need to obtain a HIPAA waiver to consent families off the 
Autism clinic waitlists.  We are requesting a HIPAA waiver because it would not be possible to 
contact families to secure their interest in Autism ALERT without getting some information to 
contact them with.  Having participating clinics contact families would place an unreasonable 
burden on clinic administrative staff, who are already overwhelmed by very long wait lists for 
autism services. 
 
Non-English Speaking Subjects 
      Study materials will be available in English and Spanish. At the time of the referral, Spanish 
speaking patients can receive a study packet, including the study interest form, in Spanish.  
Navigator services in Spanish will also be available, so Spanish signed consent can be obtained 
by the study team.    We cannot enroll non-English/non-Spanish speakers in the study, because 

 
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from a scientific standpoint their resource use would be quite different.  In addition, the low 
numbers of enrollees in this group might create imbalances in the intervention and control 
arms that would make data interpretation challenging. 
    For the expansion, we will offer non-English/non-Spanish speakers the Autism ALERT 
navigation support; however, they will not receive the program evaluation measures because 
they have not been validated in other languages.  We are working to make the evaluation 
measures available in more languages currently.   
 
              Assent of Children and Parent Permission 
 Since the children in the children/parent dyads in the study will be 5 years old or younger 
and have developmental difficulties, the capability of the children is so limited that they cannot 
reasonably be consulted about this research. For this reason, parental consent as described 
above and child assent will not be obtained. 
 
            Adults Unable to Consent/Decisionally Impaired 
        Adults who are unable to consent or who are otherwise decisionally impaired will not be 
considered eligible for the study at this time.  
 
 
6) 
Procedures 
Data collected from children and families includes process data about interactions with 
families, family survey data, and administrative data about children’s medical and educational 
services use.  Process data about interactions with families will be collected by family 
navigators (who are part of the research team) using the Care Coordination Management Tool 
and the Navigator Fidelity Checklist, which are study tools adapted from existing measures. 
Only members of the study team will have access to these data, and these data will be securely 
kept on the OHSU Sharepoint secure cloud storage throughout the study.  These data are 
collected for the purposes of evaluating this research project. 
Survey data from families will be collected in both study arms primarily via a mailed 
and/or online survey. The survey will be sent upon enrollment and 6 months after enrollment 
in Autism ALERT or the comparison intervention. Prior to the 6 month post-enrollment survey, 
a letter will be sent to families informing them of the upcoming survey and the $50 incentive 
for completion. A $50 cash or gift card incentive will be provided for survey completion.  The 
survey will initially be sent 3 times via a secure RedCap link.  Then non-responders will be 
contacted via telephone.   Subjects who do not respond to either email or telephone will be sent 
a survey mailing with a $5 Dutch Bros coffee card.   The survey will be marked with a study 
number only and will contain no personal identifiers.  The study team will have a separate 
locked document that has the key linking study ID to personal information (see below).    
Completed surveys will be mailed back to the study team in an envelope and entered into a 
secure database behind the OHSU firewall. Original copies will stored in a locked file cabinet in 
the study team area.  
For the expansion, survey data from families will be collected primarily via a mailed 
and/or online survey. The survey will be sent upon enrollment and 6 months after enrollment 
in Autism ALERT. Prior to the 6 month post-enrollment survey, a letter will be sent to families 

 
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informing them of the upcoming survey and the $10 incentive for completion. A $10 cash or gift 
card incentive will be provided for survey completion.  The survey will initially be sent 3 times 
via a secure RedCap link.  Then non-responders will be contacted via telephone. Subjects who 
do not respond to either email or telephone will be sent a survey mailing with a $5 Dutch Bros 
coffee card.  The survey will be marked with a study number only and will contain no personal 
identifiers.  The study team will have a separate locked document that has the key linking study 
ID to personal information (see below). Completed surveys will be mailed back to the study 
team in an envelope and entered into a secure database behind the OHSU firewall. Original 
copies will be stored in a locked file cabinet in the study team area. 
Study team members will also be reaching out to families via email and/or phone, about 
participating in a semi-structured phone interview regarding their experiences with navigators, 
and the overall Autism diagnosis process. Families will be contacted via email and telephone to 
schedule these interviews. Participating families will receive $50 for completing the interview. 
Interviews will be recorded using WebEx or a digital audio recorder. These recordings will then 
be sent to GMR Transcription (HIPAA-compliant) to provide transcripts. Finally, the study team 
will code the interviews using Dedoose software to get a better understanding of parents’ 
experiences in the Autism evaluation process.  
Administrative data about children from the ecWeb (EI/ECSE) database will be governed 
by a Data Use Agreement (DUA) between Dr. Zuckerman (PI) and the Oregon Department of 
Education (ODE) . Consistent with our prior DUA’s, we will request ecWeb access for only 
families with signed consent and a FERPA release for each child’s educational data.   The study 
team will submit names and dates of birth of people who signed consent and authorization to 
ODE staff, and ODE staff will allow the study team direct access to these individuals’ data within 
ecWeb, ODE’s database for Early Intervention.   ODE staff are only releasing data and will not 
be considered engaged in research.   These data include details on the dates and times of each 
child’s referral, evaluation, and service plan.   ODE staff will provide access to these data, which 
study team members will analyze, and are not considered part of the study team. 
After consent, secure emails may be transmitted between the family navigator and the 
PCP, which may contain family information. These emails will be sent via encrypted email using 
the OHSU Secure Mailbox.  This technology requires outside users to log into a website behind 
the OHSU firewall to send/receive the encrypted email, which minimizes the risk of privacy 
breach. Secure messages also automatically expire 30 days after creation and are removed from 
the Secure Mailbox server.  Autism ALERT will also have a PCP interface in which PCPs can 
contact the study team and monitor the status of their patients.  This interface will be part of 
OHSU’s RedCap database and thus will also be hosted behind OHSU’s firewall.  It will require a 
unique user ID and password, which the study team will assign to each PCP.  Each PCP will only 
be allowed to view his/her own patients on the secure website.  
We will also survey providers about intervention fidelity, feasibility and acceptability. 
Survey data on providers will be collected via a mixed mode (in-person, email, mail, fax) 
survey, upon enrollment, at the end of subject enrollment (about patient portal use only) and at 
the end of the study intervention period. The survey will be sent to all providers whose clinics 
participated in the study, whether or not they were assigned to the study intervention or 
actually used Autism ALERT. Surveys will initially be sent to providers in person or via an email 
link, which will connect to a secure RedCap server. The survey will require entry of a study 
number only and will contain no individual identifiers. Non-responders, identified by a locked 

 
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key document to associate their names with their study IDs, will be sent follow-up emails, and 
will also be given the option to complete the survey via mail or fax.  Paper surveys will be 
stored securely at OHSU as outlined above and destroyed approximately 6 months after 
publication of study results.  The patient portal survey will be anonymous and no study ID or 
PHI will be entered.  In addition to the survey, chart review data will be collected which 
contains information about each provider’s practice patterns.  These data are collected once 
every 3 months, in both arms.  These data include number of children screened for ASD and 
number of children referred to EI/ECSE for an ASD concern.  Note that referrals to Early 
Intervention are a separate process that is standard of care, and is not related to enrollment in 
the study.   Providers will be encouraged to adhere to standard of care in terms of screening 
children for autism and referring to Early Intervention; however this process can be 
accomplished by usual methods without enrolling children in the study if providers prefer.  
Number of children screened for ASD, and screening test results, will be collected by a practice 
administrator, using an existing form that we have used in prior research projects. The 
administrator will be considered engaged in research through an IAA.  This form will be 
encrypted and sent to the study team electronically using OHSU’s secure server. Finally, fidelity 
data (e.g., PCP-Navigator Contact Log) will contain information about interactions between the 
PCP and the navigator.  This file will be kept encrypted and stored on OHSU Box, a secure cloud 
server. 
Follow-up provider interviews: Using data already collected from participating clinics, study 
team members will review referral rate data from all 41 participating pediatricians and stratify 
each according to referral rates; then, we will identify the highest-referring (top) and lowest 
referring (bottom) quartiles. High- and low-referring pediatricians will be invited to participate 
in a video qualitative interview, via email solicitation from the study team.  Providers will be 
emailed the information sheet as part of their study invitation; the information sheet will 
be reviewed and  and a verbal consent will be recorded prior to the interview. . They will 
be compensated $100 via clincard for participation after the interview. The interview will use 
Chart Stimulated Recall, a case-based interviewing technique which explores clinical reasoning 
and management decisions by guiding pediatricians to reflectively review medical records.  For 
each pediatrician, the study team will select 2-3 patients with positive screens to Early 
Intervention services. With the study team, the pediatrician will review each patient’s chart to 
discuss their recollection of the screening process, and why they did/did not refer the child to EI.  
The interviewer will also ask general questions regarding decision making about positive 
screens.  All interviews will be recorded and professionally transcribed for analysis. 
 
The pediatrician interview will last 45 minutes and use CSR methods. CSR, derived from the 
field of medical anthropology, is a case-based interviewing technique which explores clinical 
reasoning and management decisions by guiding pediatricians to reflectively review patient 
medical records.  It permits patient, environmental, system, and other factors that can influence 
clinical decisions to emerge. CSR has been successfully used in other primary care research 
settings, such as with HIV screening.  For each pediatrician, the study team will use the Autism 
ALERT database to select 2-3 of their patients who screened positive for ASD. Guided by the 
study team, the pediatrician will review each patient’s chart notes with PHI redacted to discuss 
their recollection of the screening process, and why they either ultimately choose to refer or not 

 
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refer the child to Early Intervention Services. At the end of the CSR, the interviewer will ask 
general questions regarding decision making about positive ASD screens.   
 
Qualitative Interview process. Interviews will be via telephone or videoconference on Webex,  
per subject preference, and last approximately 45 minutes.  Immediately after each interview, 
the interviewer will create a structured memo describing the interview’s key findings, 
interviewer reflections, and areas for future investigation. Memos will be distributed to all team 
members for review. All interviews will be recorded and professionally transcribed for 
analysis. 
 
 
7) 
Data and Specimens 
a) Handling of Data and Specimens 
Four  types  of  data  are  collected:  System  Process  Measures,  Family-Reported  Measures,  
PCP-Reported Measures, and Administrative Measures. Data will be stored behind an OHSU 
firewall on Onedrive/Sharepoint io, a contracted secure cloud storage provider. Data will be 
destroyed about 6 months after publication of study results. Study interest forms will be sent 
via fax to the study team. The website providing PCP and Navigator access will be built by the 
OHSU IT department in RedCap, and will have the same security as any OHSU web applications.  
 
b) Sharing of Results with Subjects 
A summary of the study’s findings will be shared at multiple community meetings 
around Oregon.  As a result, some patients and providers will be notified of study results.  
However, we will have no consistent system for notifying patients or providers of study 
findings.  Families who wish to receive copies of study publications can notify the study team. 
An anticipated incidental finding is that children are found to have another 
developmental condition (instead of autism) in the context of their evaluation by Autism 
ALERT.  We expect that this may be the case in 30-40% of children referred to the program.  In 
these cases, the Autism ALERT navigator will connect these children to appropriate 
developmental resources for that condition.  Because the Swindells Resource Center has 
expertise in a large number of developmental conditions, the navigator should have the 
resources to do this.  In addition, the information will be communicated back to the child’s PCP 
via the secure Autism ALERT interface. 
 
c) Data and Specimen Banking 
This study will be registered at ClinicalTrials.gov upon IRB approval.  Study findings will 
be submitted to ClinicalTrials.gov according to its submission policy.  All consent materials will 
include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov.  
OHSU has an internal policy in place to ensure that clinical trials registration and results 
reporting occur in compliance with policy requirements. 
For the initial intervention only, we will also report data to the National Database for 
Autism Research (NDAR), which is part of the NIMH Data Archive.   All consent materials will 
include a specific statement relating to posting of study information at NDAR.  NDAR data may 
be used for future unspecified research. The OHSU researchers will not otherwise save or use 
the data for future research so there is no OHSU repository. Only data on individuals who 

 
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signed authorization for release will be submitted to NDAR and ClinicalTrials.gov; i.e. no chart 
review or screening data will be submitted. 
 
8) 
Data Analysis 
Process data from CCMT and Navigator Fidelity Checklist will be used to calculate contact 
attempts, time to first contact, total time spent per family, and counts of specific navigator 
activities. Families who complete all calls will be compared to those who broke off contact, and 
specific points of participant drop-off will be calculated. We will assess whether specific 
intervention activities varied by family demographic characteristic and clinic site, to assess 
variability in acceptability, using bivariate analyses.  Family survey data will also be used to 
assess feasibility and acceptability. Initial analyses will focus on families who participated in 
ALERT, assessing experience of care and improvement suggestions. Next, post-intervention 
family experience will be compared in intervention vs. control clinics using bivariate analyses 
with an intention-to-treat approach. We will also examine variation in experience outcomes 
overall, and by study arm, by demographic characteristics, in order to assess whether the 
intervention was appropriate for diverse families, and to target improvements. Parent 
responses to open-ended items will be assessed via conventional content analysis. Using the 
parent interviews, we will also qualitatively assess families’ feelings towards the evaluation 
process, and for the intervention arm we will also be looking at experiences with family 
navigators.  
 
PCP process data will be used in a similar fashion. PCP/Navigator interactions will be 
descriptively characterized, using the PCP-Navigator Con-tact log and use of the PCP Website. 
PCP survey data will be used to characterize PCPs’ post-intervention experiences. PCPs’ overall 
experiences will be compared in both arms using bivariate testing, and open-ended questions 
will be coded. 
We  will  refine  our mechanism  hypotheses  and measurement  by  examining change  in 
family-and provider-reported  outcomes  (e.g., stress,  empowerment) pre-and  post-
intervention,  in  both  study  arms, primarily using  descriptive  and  bivariate tests. 
Exploratory  analyses  will  assess  whether mechanism outcomes  differ by family  
race/ethnicity,  English  proficiency,  or  insurance  type, both overall and by study arm, using 
bivariate or limited multivariable regression analyses. This will allow us to gather valuable 
descriptive data on variation in engagement of target mechanisms, which might allow for 
individualized messaging in future research. 
We will compare efficacy outcomes in the Autism ALERT group to the baseline and control 
groups, using bivariate analyses and Kaplan-Meier curves for time to treatment variables. 
Estimated effect sizes for the subsequent R01 will be measured using Cohen’s d. To test 
engagement of target mechanisms, we will assess whether efficacy outcomes differed by 
mechanistic outcome (e.g., whether parental stress was associated with time to treatment), 
using bivariate or limited multivariable models. We will also assess whether outcomes differ 
according to family demographic characteristics, both overall and by study arm, to test 
variability in intervention effects. Secondary and exploratory efficacy outcomes from ecWeb 
and Medicaid claims will be analyzed in the same framework. 
Fidelity outcomes include both structural measures (e.g., receipt of program components) 
and procedural measures (e.g., quality of delivery of these components). We will use descriptive 

 
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statistics to assess delivery of the START Autism ± Autism ALERT training curriculum 
components. We will also use descriptive statistics to calculate navigator fidelity to the protocol, 
using the Navigator Fidelity Checklists. Checklists will also be cross-checked with recorded calls 
to assure accurate documentation. We will use descriptive statistics to characterize PCP use of 
the Autism ALERT website. To understand how Autism ALERT and START Autism altered PCP 
screening and referral behaviors, we will assess rate of ASD screening and EI/ECSE referral in 
both study arms in the baseline condition, and 3-and 6-months after initiation of START Autism 
±Autism ALERT. As an exploratory analysis, we will assess whether racial/ethnic or language 
differences in PCP screening are present, and whether they vary by study arm or by PCP/clinic 
characteristics. 
Our  goals  in  this pilot  study  are  to  assess  the  feasibility  and acceptability of the 
intervention and analysis, develop hypotheses regarding mechanism of action, and to provide 
context for defining meaningful differences and otherwise inform R01 power calculations. We 
intentionally have not powered to detect statistically significant differences. However, estimates 
will provide preliminary evidence of intervention effects, generate effect size estimates, and 
will help refine analytic strategy, efficacy hypotheses, and sample size estimates for a larger 
study. 
Similar quantitative and qualitative approaches will be used for the expansion, except that 
there will be no control group so analyses will be primarily descriptive.  We will also compare 
families who did versus did not engage in the Autism ALERT intervention after consenting.  
 
Folllow Up Provider Interviews: Analysis of the provider interviews will use a phenomenological 
approach. We first will use structural coding to generate a limited set of predetermined codes to 
categorize data broadly. This initial coding structure will be reviewed after an initial read of 2 transcripts 
from each respondent class. Subsequently an emergent coding approach will be used by 2-3 trained 
research assistants, establishing novel codes to explore each global category with greater precision, 
using Dedoose.  A final framework will be reviewed by 2 new pediatricians for triangulation.   
 
 
9) 
Privacy, Confidentiality and Data Security 
Administrative Safeguards: Only individuals on the study team have access to human 
subjects’ materials. All electronic human subjects’ data are stored on OHSU's network or Cloud 
behind OHSU's firewall. Individuals are only able to access human subjects’ data through 
OHSU's network, which requires authentication through use of strong passwords. Access rights 
to folders will be granted only to project staff identified on the IRB protocol.  
Physical Safeguards: All physical data (e.g., survey instruments, study consent forms, process 
data collected on patients and families) will be stored on the OHSU campus or at Providence 
Swindell’s Center, in a locked file cabinet in the study team area, which is in a secured building.  
The study team area is separated from the rest of the building by a door that is locked at the end 
of each business day. All output containing individual identifiable information is treated as 
confidential data. This information is never transferred electronically via email or other 
protocols except via OHSU’s Secure Mailbox. Shredders are used on any printed material 
containing individual identifiers. All physical human subjects’ data (e.g., surveys) will be 
destroyed 6 months after publication of study results.  Study interest forms will be faxed to the 
study team and securely stored on site.   

 
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Electronic Safeguards: All electronic data files for this study are kept on the OHSU network, 
behind the OHSU firewall. This network is monitored regularly and is accessible only to key 
personnel; as a result, the risk of unlawful penetration is very low. All data files are stored on 
the server, thereby eliminating the need to house data on laptop computers that are generally 
more of a security risk. OHSU’s Information Technology Group (ITG) administers and maintains 
individual workstations, users’ network folders, and group shared folders. Multiple daily 
snapshots of user network folders and group shared folders are made automatically and are 
available to be restored by the user without interaction by ITG. This makes version control of 
these folders very robust. Individual workstations are not backed up automatically; however, 
neither critical nor protected health information is stored on individual workstations. 
 
10) Risks and Benefits  
a) Risks to Subjects 
Given that the probability of physical or psychological harm anticipated in this research 
is quite low, this study meets criteria for minimal risk research. However, there are some risks 
to both patients and providers. There is a risk of loss of protected subject data.  This could 
happen during transfer of data from outside sites to OHSU or internally at any site.  We will 
take multiple measures to mitigate this risk (see below).It is possible that families may 
experience discomfort or embarrassment as a result of the Autism ALERT intervention, 
especially since the family navigator may need to ask the family personal questions in order to 
better connect them with resources. It is also possible that patient’s parents may falsely believe 
their child has autism if he/she is referred to Autism ALERT prior to receiving a full evaluation 
for autism. Thus it is possible that some families will be unnecessarily worried as a result of the 
intervention. However, research suggests that 90% of children who fail an autism screener have 
some kind of developmental condition, even if it is not autism. Thus, the risk of unnecessarily 
worrying families is rather low.  We will connect families of children who are diagnosed with 
other developmental disabilities instead of or in addition to ASD, to the appropriate services. 
Similar risks may be applicable to providers—they may too experience discomfort knowing that 
a research team will be following up with patients whom they have identified to be at risk for 
autism. However, since enrollment in Autism ALERT is optional, providers who feel 
uncomfortable do not have to participate or enroll their patients, and individual providers can 
opt out of this research at any time. 
 
 
b) Potential Benefits to Subjects 
We anticipate that all subjects may benefit from the proposed research study, regardless 
of the arm of the intervention to which they are assigned (i.e., Autism ALERT + START Autism or 
START Autism only), because they will receive higher-quality ASD care overall. Providers in 
both arms of the study will benefit from the additional training around how to appropriately 
conduct developmental and autism-specific screenings. We anticipate that all providers will 
also benefit from additional information on the autism referral process, thus making them 
stronger practitioners for future patients. Further, we anticipate that families in the Autism 
ALERT + START Autism arm of the intervention will benefit from having an accelerated process 
in the diagnosis and treatment of autism; we anticipate that having a family navigator will 

 
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boost these family’s empowerment and self-efficacy around making healthcare decisions for 
their child with autism. We anticipate that families in the START Autism only arm of the 
intervention will reap the benefits of the study indirectly from their child’s health care 
provider, whom will train to better identify and treat autism.