Addressing Racial Disparities in Autism Diagnosis and Treatment: Translating Peer-to-Peer Support Into a Clinical Setting
Phase: NA
Conditions: Development Delay, Neurodevelopmental Disorders, Autism
Sponsor: University of Maryland, Baltimore

 
 
 
 
 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
Full Title: Addressing Racial Disparities in Autism Diagnosis and Treatment: Translating Peer-to-Peer 
Support into a Clinical Setting 
Institution: University of Maryland, Baltimore 
NCT Identifier: NCT04313283 
Unique Protocol ID: HP-00090447 
Secondary ID: 1UL1TR003098 
PI: Sarah Dababnah, PhD 
Co-PI: Charina Reyes, MD 
Date Last Approved by Institutional Review Board: 09/01/2022 (original approval: 03/26/2020) 
 
 

 
Justification, Objective, & Research Design 
Specific Aims 
Aim 1. Deliver Parents Taking Action to caregivers of Black children with developmental delays on a 
waitlist for an autism or developmental evaluation. Parent Leaders (parents of children 9+ years and older 
with autism) will deliver the program to 20 caregivers of waitlisted children (ages 8 and younger). We 
include children referred for autism or developmental concerns, as well as older children, due to concerns 
about late and/or inaccurate referrals of Black children. 
 
Aim 2: Assess the feasibility, acceptability, and short-term outcomes of Parents Taking Action with a 
clinical sample. We will measure pre/post changes in child (challenging behaviors) and caregiver 
outcomes (parenting stress; depression; and family functioning, including social support); and evaluate 
intervention process measures (acceptability and fidelity). We hypothesize the intervention will be 
acceptable and feasible and improve child and caregiver outcomes. 
Design  
Phase 1: We will expand our advisory group to include Brown on the Spectrum (BOS) and SOM 
representatives and other relevant stakeholders. This group will advise us on local service needs and 
potential barriers and facilitators for implementation. We will continue to consult with this group 
throughout the research process. 
 
Phase 2: To address Aim 1, we will identify and train four additional Parent Leaders (parents of children 
ages 9 years or older with autism). SOM clinical staff will identify eligible children and their families as 
they are added to the waitlist. The clinical team will also accept referrals internally from UM providers. 
We will send a letter from the research team leaders to potential participants via email (if available) and 
mail. The letter will let potential participants know that a research team member will be calling them 
about the study. The letter will also provide the research team's contact information, along with more 
study information. If participants are interested in the study, the research team member will go through 
the informed consent and intake processes. The research team will match Parent Leaders with caregivers, 
and provide caregivers with case management for housing and other needs. 
 
Phase 3: To achieve Aim 2, we will evaluate program outcomes. Intervention participants will complete 
measures at three time points. Additionally, the Parent Leaders will complete weekly fidelity checklists. 
At the end of the program, we will interview intervention participants and Parent Leaders (separately) 
about the program, in order to obtain in-depth qualitative data on intervention acceptability and 
feasibility. We hypothesize Parents Taking Action 1) will be acceptable and feasible; 2) will reduce 
problem child behaviors, parent stress and depression; and 4) will improve family functioning. 
 
Phase 4: We will complete data analyses, prepare manuscripts and conference presentations for peer 
review, and draft external grant proposals. 

Study Procedures 
This protocol involves two groups of human subjects: Parent Leaders (caregivers of older children with 
autism who deliver the intervention) and intervention participants (caregivers of children on an autism or 
developmental evaluation waitlist). The procedures for these groups are described below. 
 
Parent Leaders Procedures 
Once Parent Leaders consent to join the study, they will engage in a training program led by the research 
team. After they complete the training, they will be matched with intervention participants and deliver the 
12-week program. Parent Leaders will provide two types of data. First, at each intervention session, the 
Parent Leader will complete a fidelity checklist to ensure the program is being delivered as intended. A 
member of the research team will also observe the Parent Leader during two sessions per participant and 
complete the fidelity checklist. Second, Parent Leaders will participate in a one-on-one interview after the 
program is complete. These interviews will occur in private conference rooms at the UMB School of 
Social Work and be led by research staff; or by video conference/phone as needed. 
 
SSW staff will match Parent Leaders with eligible families. Parent Leaders can generally accommodate 
two to three families each at a given time; thus, recruitment will be ongoing such that Parent Leaders can 
serve approximately five families each over the one-year research period. In order to participate in the 
final interviews, we will also obtain informed consent from Parent Leaders. 
 
Intervention Participants Procedures 
We will recruit potential intervention participants through local waitlists for a developmental or autism 
evaluation. (Children, particularly toddlers, who ultimately receive an autism diagnosis are often referred 
initially for developmental concerns.) To be eligible, participants must be the primary caregiver of a child 
eight years old or younger; and, identify their child as Black or African American. SOM clinical staff led 
by Dr. Charina Reyes will identify eligible children and their families from UMB's Developmental-
Behavioral Pediatrics waitlist. We will also provide flyers to local providers, including general 
pediatricians, with Dr. Reyes' name (if providers can send a secure referral through Epic) or the research 
team information (for potential participants to contact the team directly). Dr. Reyes will share the names 
and contact information of potential participants in a SharePoint Excel file only available to the research 
team which includes researchers from SOM and SSW. The research team will mail and email letters to 
potential participants the SOM clinical team identifies. The letter will provide the research team's contact 
information, and also notify the potential participants that a research team member will call them in the 
next week. All staff will follow strict protocols to protect the confidentiality of participant information, 
described in subsequent sections of this protocol. When the research team contacts potential participants, 
they will screen for the inclusion criteria described above before going through the informed consent and 
intake processes. 
 
Research team staff will meet eligible potential participants in a private place and review the study 
information sheet in detail. Once the potential participant expresses comprehension of the risks and 
benefits of the research and agrees to participate, research staff will ask the participant to give verbal 
consent. The study staff will then request participants to complete baseline data (described below). 

Participants will receive $50 when they complete the questionnaires after completion of module 1 and 
another $50 when they complete the final questionnaires and interview. 
 
NOTE: As needed, we will complete meetings and intervention delivery remotely. We will use secure 
video conferencing software (e.g., Webex, available through UMB) which allows phone-in or video 
joining options. For data collection, we will send participants secure Qualtrics links (a survey software 
available at UMB) to complete surveys. We will conduct and record interviews using video conferencing 
software (e.g., Webex). 
Duration of Participation  
Parent Leaders will be required to participate in 30-32 hours of training of Parents Taking Action 
Program, led by research staff. The Parent Leaders will work one-on-one with intervention participants to 
deliver two six-week modules (12 weeks total). Each Parent Leaders will be matched with approximately 
4-5 caregivers each. Given it is not necessary for intervention participants' sessions to run concurrently, it 
is possible that Parent Leaders will deliver the intervention to their assigned caregivers through April 
2021. We aim to hold the Parent Leaders post-intervention interviews in April 2021. These interviews 
will last approximately 60 minutes. 
 
Three-time points measures (pre, post-module 1, and post-module 2) will take approximately one hour 
each for participants to complete. Post-intervention interviews with research staff will last approximately 
60 minutes. We will use the same questionnaires for the three time points. 
 
As noted above, as needed, we will hold the Parent Leader Training and intervention virtually. 
Sample Size and Data Analysis 
A convenience sampling method is appropriate for testing the feasibility and acceptability of this pilot 
trial. We aim to recruit additional 4 Parent Leaders and 20 intervention participants for this study. We will 
recruit potential intervention participants through waitlists for developmental or autism evaluations. 
(Children, particularly toddlers, who ultimately receive an autism diagnosis are often referred initially for 
developmental concerns.) To be eligible, participants must be the primary caregiver of a child eight years 
old or younger; and, identify their child as Black or African American. 
Quantitative Data Analyses 
Based on a power analysis (α = .05; effect size = .3; main outcome: parenting stress), we project a sample 
of 20 families adjusted for 10% attrition. We will use Generalized Estimating Equations (GEE) to analyze 
changes over time in parenting stress, caregiver depression, child behavior, and family functioning. Since 
we have three time points of data collection, we will use a commonly used method in repeated measures 
design, complete case analysis, to validate intervention effects (Bell, Fiero, Horton, & Chiu-Hsieh, 2014). 
In our study, we will consider baseline and T1 data (following completion of Module 1) a complete set. 
Furthermore, we will follow the manuals of our measures for protocols for missing data at the item level. 
For those measures without such guidance, we will use the Markov chain Monte Carlo multiple 
imputation method to address item-level missing data. 
 

Qualitative Data Analyses  
We will digitally record interviews and create an initial codebook based on the semi-structured interview 
guides. We will then analyze audio transcripts in NVivo 11 and code using open and axial coding 
processes. Consistent with grounded theory method (Corbin & Strauss, 2008), we will consult field notes, 
quantitative data findings, and research and program staff as themes emerge. We will actively seek 
responses not fitting the dominant themes (disconfirmatory responses) in order to understand the diversity 
of informants’ perspectives. Dr. Dababnah and her research team will consult with Dr. Reyes on final 
codes and themes until we reach consensus. 
 
Data Integration 
To aid our interpretation of the data, we will compare our data findings by reporter (e.g., Parent Leader 
versus caregiver acceptability) as well as type (e.g., qualitative versus quantitative caregiver 
acceptability). 
Surveys/Questionnaires 
1. Pre-post survey including demographic questionnaire and service use form, Nisonger Child Behavior 
Rating Form, Autism Parenting Stress Index, Center for Epidemiological Studies-Depression, Family 
Outcomes Survey-Revised 
2. Post-intervention Social Validity Questionnaire 
3. Weekly Procedural Fidelity Checklist Self-Assessment for Promotora Home Visits 
4. Post-intervention Interview Guides for Parent Leaders and Parent Leaders 
Duration of Expected Completion  
1. Pre-post survey: 1 hour 
2. Social Validity Questionnaire: 5 minutes 
3. Weekly Procedural Fidelity Checklist Self-Assessment for Promotora Home Visits: 5 minutes 
4. Post-intervention Interview Guides for Parent Leaders and Parent Leaders: 1 hour 
Audio or Video Recording 
We will audio record the post-intervention interviews to ensure we accurately capture their responses for 
our data analyses. Audio files will be saved using anonymous identifiers, rather than names or other 
identifiable information. Further, individuals will be instructed to not share their or their children's names 
in the interviews. The audio files will be professionally transcribed. Research staff will verify the 
transcript for accuracy and remove any identifying information that was unintentionally shared. Audio 
files will be deleted once transcripts are verified for accuracy. 
Intervention Description 
Parents Taking Action is an intervention originally developed to increase service access and knowledge 
among low-income Latino children with autism and their families (Magaña, Lopez, & Machalicek, 2017). 
In a previous study, we worked closely with our community advisory board to make cultural adaptations 
to the manual for use in Baltimore with a majority Black population. We adapted the program to deliver 

content in two six-week modules (12 weeks total). The first module introduces topics on typical child 
development, autism and other developmental delays, common interventions and other methods to 
address child needs, parent stress and depression, and advocacy. The second module presents more 
advanced methods to improve social communication, reduce challenging child behaviors, and increase 
social support. We also provide participants with social work services to address challenging life 
circumstances, such as housing instability and food insecurity. 
Participant Selection 
The study is open to adults (18+) of any gender, race or ethnicity, provided they meet the inclusion 
criteria specified below. We will not target any vulnerable populations.  
Inclusion Criteria: 
1. [Parent Leaders Participant] Parent or other primary caregiver of a child age nine years or older with 
autism or other developmental disability 
2. [Intervention Participant] Parent or other primary caregiver of a child age eight years or younger on 
waitlist for autism or developmental concerns 
3. [All Participants] Identifies self or child as Black or African American  
Recruitment 
Intervention Participants 
We will recruit potential intervention participants through waitlists for developmental or autism 
evaluations at UMB Developmental-Behavioral Pediatrics and other local clinics. (Children, particularly 
toddlers, who ultimately receive an autism diagnosis are often referred initially for developmental 
concerns.) We will recruit participants using two methods: 
1) Distribute flyers describing the study to local clinics with autism or developmental evaluation waitlists 
as well as to primary care providers. The flyers will provide information for potential participants to 
contact the study team directly; or for providers to refer potential participants to Dr. Reyes securely 
through Epic. 
2) Dr. Reyes will review her clinic's (UMB Developmental-Behavioral Pediatrics) waitlist to determine 
eligible participants. In addition, Dr. Reyes and Co-I Dr. Badawi will also review potential participants 
referred to them securely through Epic, to identify potential participants for research team to contact. The 
names and contact information will be added to a secure file on SharePoint. Before making initial contact, 
the study team will mail letters via postal mail and email that describe the study, notify caregivers that a 
research team will be contacting them, and provide the research team's contact information. Future 
telephone contacts with potential participants will begin by the research team referring to previous 
contacts. 
Parent Leaders 
SSW study staff will recruit potential Parent Leaders primarily through our existing Autism Advisory 
Group and other local contacts. The PI (Dr. Dababnah) and a program manager will meet each Parent 
Leaders in person to determine if they meet eligibility criteria and discuss Parents Taking Action and the 

research process. Parent Leaders will be paid for their time delivering the intervention, and thus will need 
to fill out paperwork to be compensated through UMB. 
Measures to Prevent Coercion 
Our research team will discuss the study with individuals who approach us directly through our flyers or 
through providers at the Developmental-Behavioral Pediatrics Clinic), or with those to whom we have 
sent an initial letter describing the study. We will explain that their participation is completely voluntary 
and then can withdraw from study at any time without penalty. Neither their participation in the study, nor 
a decision to withdraw, will not impact any services they may receive at the University of Maryland, 
Baltimore and/or University of Maryland Medical System. The statements regarding individuals' 
participation and right to withdraw are reiterated in the study information sheet, which will be reviewed 
with each participant. 
Text of Advertisement 
Maryland Parents Taking Action 
 
Did you know that Black and African American children receive an autism diagnosis much later than 
white children? 
 
This means that they often miss out on early intervention and other important services. 
 
Parents Taking Action supports mothers, fathers and other primary caregivers in Maryland whose child is: 
❏ Black or African American 
❏ 8 years old or younger 
❏ On the waitlist for an autism or developmental evaluation 
 
Maryland PARENTS TAKING ACTION supports parents to develop skills to communicate and play 
with their children, manage challenging child behaviors, and advocate for needed services. 
 
Maryland PARENTS TAKING ACTION is led by trained Parent Leaders, who themselves are parents of 
Black children with autism or other developmental disabilities. 
 
The free program meets for two hours weekly for 12 weeks. It’s one-on-one and meets when caregivers 
want! 
Caregivers will receive up to $100 for answering questions before, during and after they participate in the 
program, which will help us understand how the program is working. 
 
If you a provider, please contact Charina Reyes, MD through Epic to refer any potential participants. 
 
If you are a caregiver, or want more information, please contact our study team at 
autismstudy@ssw.umaryland.edu or call 443-509-2550. 
Research Related Risks 

When appropriate, we have listed the risks separately for intervention participants and Parent Leaders: 
 
Risk for Intervention Participants 
1) There is an unlikely risk for emotional distress resulting from completing the questionnaires. We 
believe the frequency of this risk is low. We will minimize this risk by ensuring participants have referrals 
to trained social workers, psychologists and other mental health professionals who are knowledgeable 
about resources in the community for children with autism and their families. We also will maintain a list 
of other community resources for participants to access. (See Resources Guide attached under "Additional 
Documents.") Finally, we have created a safety plan (see "Safety Plan" under "Additional Documents") 
for those participants who experience distress due to completing the questionnaires and/or participating in 
the parenting program. 
 
2) As with any program involving parents, there is the possibility participants will disclose child abuse or 
neglect, or the possibility of hurting oneself or others. All individuals named on this protocol are 
mandated to report suspected or documented child abuse or neglect to Child Protective Services. If an 
intervention participant disclosed child abuse or neglect to a Parent Leader, or the Parent Leader observes 
such abuse, then the Parent Leader will immediately report this to PI (Sarah Dababnah) who will report to 
Child Protective Services. Participants’ disclosure of harm to oneself or others is also immediately 
reportable. Such instances, thus, would result in disclosure of personal information to the appropriate 
authorities. The contact information for these authorities can be found in the "Safety Plan" (see 
"Additional Documents"). These are the only instances in which research staff will disclose personal 
information about a participant in this research to individuals not involved in the study. 
 
Risks for both Parent Leaders and Intervention Participants 
1) There is a risk of loss of data confidentiality. We believe this risk is low. We will minimize this risk by 
maintaining strict confidentiality protocols to protect participants' identities, which we explain 
subsequently in the "Privacy of Participants" and "Confidentiality of Data" sections. In summary, first, we 
will use unique identifiers on paper and digital files. Only a linking file will connect names and other 
identifying information to study information. Second, we will remind participants to not use identifiable 
information in their responses to the questionnaires or the interviews. However, if they do, research staff 
will remove this identifiable information from study documents. Third, we will remind all groups 
involved in this research that confidentiality is expected. (These groups include intervention participants, 
Parent Leaders, and the Autism Advisory Group. The latter group will not be involved directly with the 
research; however, it is possible they will refer potential Parent Leaders and/or intervention participants to 
the study.) 
 
2) There is the possibility of a rare breach of privacy when completing the questionnaires and/or 
participating in the interviews. We will minimize this risk by providing participants with private spaces to 
complete the questionnaires and participate in the interviews, as described in the section "Privacy of 
Participants." 
Potential Benefits and Alternatives 
Potential Benefit to Participants  
Participants might not directly benefit from their participation in the research. However, the "Parents 
Taking Action" program may benefit intervention participants by helping them to learn new methods to 

work with their children and/or to advocate for services for their children with autism. The research may 
benefit Parent Leaders by offering them free training in an empirically supported parenting program, and 
support to deliver the program to a pilot group of caregivers. 
Importance of Knowledge to be Gained  
There are few interventions in general for caregivers of children who are in the waiting list, and little 
research on interventions appropriate for low-income and Black and African American families. The 
knowledge gained from this study will contribute to efforts to pilot a promising intervention, "Parents 
Taking Action," for Black and African American parents of children with suspected autism. 
Balance of Risks to Benefits 
We believe the risks to participants are minimal and reasonable with respect to the benefits to improve 
service options for caregivers of children on a waiting list. 
Alternatives 
Participation in the research is voluntary and the alternative is not to participate in the research. 
Withdrawal of Participants 
Researchers have the right to withdraw subjects if they have an unanticipated reaction from completing 
the questionnaires or participating in the parenting programs. We believe these circumstances will be 
extremely rare. If participants have an unanticipated reaction from completing one set of questionnaires, 
they will not complete subsequent sets of questionnaires or interviews. Also, participants have the right to 
withdraw from the research at any time without penalty. If research participants inform research staff they 
wish to withdraw from the study, subsequent data collection will cease. 
Privacy of Participants 
All staff will follow strict protocols to protect the confidentiality of participant information and their 
privacy throughout the research process. We will send informational letters about the study to potential 
participants before we contact them by phone. Once intervention participants agree to participate in the 
study, participants will be given a private space at UMB SSW to complete questionnaires or set up a time 
to administer the questionnaires in participants' homes. Research staff will be available to ask questions, 
but otherwise give participants privacy to complete the measures. Similarly, post-intervention measures 
for the intervention participants will be administered by research staff either in participants' homes or in 
private offices at UMB SSW. Post-intervention interviews with Parent Leaders and intervention 
participants will take place in private spaces at UMB SSW or another private location of the participant's 
choice (e.g., participant's home). 
NOTE: As needed, we will conduct meetings (e.g., explaining informed consent) and intervention 
delivery remotely. We will use secure video conferencing software (e.g., Webex, available through UMB) 
which allows phone-in or video joining options. For data collection, we will send participants secure 
Qualtrics links (a survey software available at UMB) to complete surveys. We will conduct and record 
interviews using video conferencing software (e.g., Webex). 

Location 
Research staff will provide research information on their office phones in private offices or meet in 
person in their private office at UMB SSW or in participants' homes. When meeting or speaking on the 
phone at UMB SSW, research staff will close their office door to ensure conservation are private. 
Environmental Stressors 
We do not believe there are significant environmental stressors from this research. 
Confidentiality of Data 
Research staff will create a unique identifier for each participant. A file linking this identifier with 
participants' names and other information will be maintained on a password-protected computer at UMB 
SSW. 
 
Hard Copy Data (Questionnaires) 
All paper data collected from participants will be labeled with their unique identifiers, rather than names. 
Participants will be directed to not enter names on the questionnaires, as the unique identifier will 
substitute for their names. Hard copies will be stored in the PI's office in a locked filing cabinet in her 
locked office, located at 525 West Redwood Street, Baltimore. If needed, we will collect questionnaires 
using Qualtrics (a secure survey software available through UMB). Please see next section about 
protection of electronic data for storage of any data collected through Qualtrics. 
 
Electronic Data (Interviews) 
Research team members will interview participants on their experience with the parenting program. 
Participants will be instructed to not provide their name or other identifiable information while the digital 
audio recorder is on. If they do share identifiable information, this information will be removed from the 
transcripts. Audio recordings and transcripts will be saved using participants' unique identifiers. Audio 
recordings will be deleted once the transcripts are verified for accuracy. These data, along with data input 
from the quantitative measures described above, will be stored in password-protected files on a password-
protected server. Only Dr. Dababnah and her designated research team members at UMB will be able to 
access folders with these data. 
Data Storage and Access 
Hard copy data will be secured in the PI's locked office in a locked file cabinet. These hard copies will not 
contain any identifying information. If a participant unintentionally adds identifiable information on the 
forms, they will be blacked out by research staff. 
 
Electronic data will be secured on password-protected computers within password-protected folders. 
Only members of the research study team will have access to the data. Data analysis results will be shared 
with funders in the aggregate. 
Payment/Reimbursement  

Payment/reimbursement to participants will be for time and effort. We will pay parents up to $100 to 
complete measures related to the parenting program. They will receive $50 when they complete the 
questionnaires after completion of module 1; another $50 when they complete the final questionnaires and 
interview. 
Protected Health Information (PHI) 
We will use the patient name, address, phone number, parent's/ guardian's name and email to contact 
potential participants about the study. The date of their scheduled appointment, if within University of 
Maryland, will also be obtained to determine when they will be seen for their developmental or autism 
evaluation. PHI is only needed for recruitment purposes, and HIPAA only applies to that portion of the 
study. We will not access PHI in other stages of the study. 
Informed Consent Process 
Once an individual indicates interest in the study, research staff will meet with them privately to discuss 
their eligibility and the information sheet in detail. Once an individual indicates comprehension of the 
risk/benefits of the voluntary research, individuals will be asked to verbally consent to participate in the 
study. If participants wish, they can take the information sheet home and think about their participation 
before they verbally agree to participate. Participants will be provided with a copy of the information 
sheet containing all of the information on their rights as a research participant, as well as contact 
information for the PI and IRB. 
Only research staff listed on IRB protocol will obtain informed consent. The consent process will take 
place in private office at UMB SSW, or in participants' homes, where potential participants can meet with 
research staff to seek clarification or ask questions prior to agreeing to take part in the research. 
 
NOTE: As needed, we will review the informed consent process with potential participants remotely. We 
will use secure video conferencing software (e.g., Webex, available through UMB) which allows phone-
in or video joining options. 
The participants will meet individually with research staff to discuss the study prior to agreeing to 
participate in the research. Staff will seek clarification that participants understand the information sheet 
before beginning research procedures. Participants will be informed they can withdraw at any time, for 
any reason. 
Waiver of Documentation of Consent 
The only record linking the subject and the research would be the consent document, and the principal 
risk would be potential harm resulting from a breach of confidentiality. We note that we do have a master 
linking file in electronic form, which links participants' names with anonymous identifiers. Only some 
people on our research team have access to the password-protected electronic linking file. However, the 
only paper document linking the subject and research would be the consent form. This signed informed 
consent document would contain participants' names and would constitute an additional risk to loss of 
confidentiality. All participants will receive a copy of the information sheet with their rights as subjects. 
The research team will document the participants' verbal consent to take part in the study.