An Integrated Nutrition Intervention Through the Part C Early Intervention Services to Promote Healthy Eating Habits for Children With ASD
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: University of South Florida

Title: An integrated nutrition intervention through the Part C Early Intervention Services to 
promote healthy eating habits for children with ASD. 
NCT number: NCT05194345 
Document date: 10/24/2022 

 
 
 
 
PROTOCOL TITLE: 
An integrated nutrition intervention through the Part C Early Intervention 
Services to promote healthy eating habits for children with ASD. 
PRINCIPAL INVESTIGATOR: 
Heewon L. Gray, PhD, RDN 
College of Public Health 
Phone: 813-974-9881 
Email: hlgray@usf.edu 
VERSION NUMBER/DATE: 
V.2 January 23rd, 2022 
V.3. October 24th , 2022 
REVISION HISTORY 
*This table should only be used during submission of a Modification application to the IRB.  
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
01/23/2022 
• Data sharing agreement added, complying 
with the NIH requirement (Section 16.). 
Parent consent form has been updated to 
include this data sharing details. This does 
not impact the EI providers’ consent.  
• Recruitment email address change on 
recruitment letters. 
• Height and weight measurement procedure 
and exit interview guides have been modified 
to improve clarity.  
Yes 
3 
09/21/2022 
• Eligibility criteria for the parent-child dyads 
has been updated  
• The timing of asking the autism spectrum 
disorder (ASD) diagnosis or at risk/monitored 
for ASD status has been updated by adding 
another time point at the 5-month follow-up 
assessment 
• The health conditions questionnaire timing 
has been updated to add “T3” – follow-up 
time point (Table 4. in Section 5.7). A short 
self-report questionnaire with the same 4 
items on health conditions/medications 
Yes 

 
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Revised: 10/24/2022 
 
assessed at baseline through the demographic 
questionnaire will be used   
• Consent forms have been updated to reflect 
the eligibility criteria and the timing of asking 
the ASD diagnosis or at risk/monitored for 
ASD status 
• A new recruitment flyer is added for the Early 
Steps to use on their Facebook page 
• ClinicalTrials.gov registration number has 
been updated 
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives ................................................................................................................ 4 
3.0 
Background .............................................................................................................. 5 
4.0 
Study Intervention .................................................................................................... 7 
5.0 
Procedures Involved................................................................................................. 8 
6.0 
Data and Specimen Storage for Future Research .................................................. 12 
7.0 
Sharing of Results with Subjects ........................................................................... 13 
8.0 
Study Timelines ..................................................................................................... 13 
9.0 
Inclusion and Exclusion Criteria ............................................................................ 13 
10.0 Vulnerable Populations .......................................................................................... 14 
11.0 Local Number of Subjects ..................................................................................... 14 
12.0 Recruitment Methods ............................................................................................. 15 
13.0 Withdrawal of Subjects .......................................................................................... 16 
14.0 Risks to Subjects .................................................................................................... 16 
15.0 Potential Benefits to Subjects or Others ................................................................ 16 
16.0 Data Management and Confidentiality .................................................................. 17 
17.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 22 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 23 
19.0 Compensation for Research-Related Injury ........................................................... 23 
20.0 Subject Costs and Compensation ........................................................................... 23 
21.0 Consent Process ..................................................................................................... 23 
22.0 Setting .................................................................................................................... 26 
 
 

 
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1.0 
Study Summary  
 
Study Title 
An integrated nutrition intervention through the Part C 
Early Intervention Services to promote healthy eating 
habits for children with ASD 
Study Design 
Randomized controlled trial 
Primary 
Objective/Purpose 
Aim 1: To refine the Autism Eats manual and 
intervention materials. 
Aim 2:  To evaluate the feasibility and preliminary 
efficacy of Autism Eats in improving dietary intake and 
mealtime behaviors of children with ASD. 
Secondary 
Objective(s)/Purposes 
To explore whether child weight status differs between 
Autism Eats and enhanced usual care groups at 5-month 
follow-up assessment. 
Research Intervention(s)  Autism Eats – Early childhood nutrition intervention 
ClinicalTrials.gov NCT # 
NCT05194345 
Study Population 
Early intervention providers and parent-child dyads (child 
aged 0-36 months clinically diagnosed with ASD) 
Sample Size 
146 individuals 
Aim 1: 10 EI providers, 10 parents 
Aim 2: 30 EI providers, 48 parent-child dyads (48 parents 
and 48 children) 
Study Duration for 
individual subjects 
Aim 1: up to 3 hours per participant to review manual and 
provide feedback. 
Aim 2:  
Parent-child dyads: The Autism Eats intervention group 
will spend about 8.5 hours over 5 months (baseline, post 
intervention, and 5-month follow-up assessments are 30 
minutes each, 25-30 minutes weekly sessions for up to 10 
weeks, two 25-30 minutes monthly booster sessions, and 
a 60-minute exit interview), and the We Can! EUC 
control group will spend about 3 hours over 5 months 
(baseline, post intervention, and 5-month follow-up 
assessments are 30 minutes each, one 25-30 minute 
nutrition session, and a 60-minute exit interview).  
EI provider: The Autism Eats intervention group EI 
provider will spend about 12 hours over 5 months (two 
90-minutes training sessions, 25-30 minutes weekly 
sessions for up to 10 weeks, two 25-30 minutes monthly 
booster sessions, 10-minute fidelity checklist completion 

 
Page 4 of 26 
Revised: 10/24/2022 
 
after each session, and a 60-minute exit interview), and 
the We Can! EUC control group EI provider will spend 
about 4.5 hours over 5 months (two 90-minutes training 
sessions, one 25-30 minutes session, 1-2-minute written 
material distribution at their 9 weekly EI sessions, and a 
60-minute exit interview). 
Study Specific 
Abbreviations/ 
Definitions  
EI=Early Intervention; EUC=Enhanced Usual Care; 
ASD=Autism Spectrum Disorder; BAMBI=Brief Autism 
Mealtime Behavior Inventory; IDEA=Individuals with 
Disabilities Education Act 
2.0 
Objectives 
2.1 There is an unmet need for nutrition interventions that address both autism 
spectrum disorder (ASD) specific feeding challenges and unbalanced eating habits among 
children with ASD to prevent future chronic health conditions. Children with ASD tend 
to consume few fruits and vegetables and mainly high-energy dense foods, including 
sugar-sweetened beverages and processed snacks. Obesity prevalence in children with 
ASD is up to 40% higher than in typically developing children, and recent studies show 
significantly elevated risks of hyperlipidemia and hypertension among individuals with 
ASD, regardless of using psychotropic medications. Considering the increased risks for 
diet-related diseases and the fact that many children with ASD develop various feeding 
problems such as selective eating patterns and food refusal, a novel intervention approach 
that addresses both ASD-specific feeding challenges and healthy eating development is 
urgently needed to prevent serious feeding problems and reduce chronic disease risks. 
Our interdisciplinary team conducted a preliminary study to examine diet quality and 
mealtime behaviors among diverse children with ASD in Florida (34% Hispanic/Latino) 
and parental preferences for nutrition interventions. Based on the study findings, we 
developed the manual for our nutrition intervention, Autism Eats, for children with ASD 
enrolled in the Part C of Individuals with Disabilities Education Act (IDEA) Early 
Intervention (EI) services. Our Autism Eats manual and parent materials are based on 
ASD-specific feeding strategies such as escape extinction and food chaining combined 
with behaviorally-focused nutrition intervention strategies such as goal setting and 
weekly meal planning to promote healthy eating. We pilot-tested the intervention with a 
small number of EI providers and parent-child dyads (n=5) to examine how intervention 
components fit with the Part C service setting. Preliminary fidelity and provider interview 
data indicated that the intervention manual was easy to follow and has potential to be 
widely implemented in the EI services, indicating a good fit. Herein, our goal is to refine 
our intervention materials and conduct a pilot RCT to test the feasibility and preliminary 
efficacy of this innovative nutrition intervention program, Autism Eats, to prevent 
problematic mealtime behaviors and promote development of healthy eating habits 
among children with ASD enrolled in Part C EI services in Florida. The Specific Aims 
are: 
Aim 1. To refine the Autism Eats manual and intervention materials.  
 

 
Page 5 of 26 
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Aim 2. To evaluate the feasibility and preliminary efficacy of Autism Eats in 
improving dietary intake and mealtime behaviors of children with ASD.  
2a. Test the feasibility of enrollment, implementation, and evaluation of Autism 
Eats.  
2b. Assess the preliminary efficacy of Autism Eats for improving child dietary 
intake and mealtime behaviors.  
 
Exploratory Aim. To explore whether child weight status differs between Autism Eats 
and EUC groups at 5-month follow-up assessment.  
 
2.2 Hypothesis 1: We hypothesize that Autism Eats will be feasible and well-received by 
EI providers and parent-child dyads.  
Hypothesis: 2: We hypothesize that there will be differences in children dietary food 
intakes, variety, diet quality, and mealtime behaviors between children who participate in 
Autism Eats and those in the EUC groups at post-intervention and 5-month follow-up 
from baseline. 
 
3.0 
Background 
3.1 The prevalence of ASD has increased drastically in recent years, with current 
estimates at 1 in every 54 (more than 2 million) children affected in the United States, 
which is approximately 10% higher than the estimate in 2014 and 175% or 2.8 times 
higher than the first estimates reported in 2000.1 In addition, Florida has the highest 
prevalence of ASD (4.88% compared to 2.9%, the national average).2,3 Without 
intervention, individuals with ASD are at significant risk for developing diabetes, 
coronary heart disease, and cancer by midlife.4  
Unhealthy food choices in children with ASD are a growing concern with 
potential for lifelong impact. Children with ASD tend to consume few fruits and 
vegetables and excess calories from high-energy dense foods, including starches, sugar-
sweetened beverages, and other highly processed foods and snacks,5-8 contributing to 
increased rates of obesity and other diet-related diseases. ASD-specific problematic 
mealtime behaviors and food selectivity should be addressed. Prior research reported that 
children with ASD experience up to 5 times more feeding problems, including 
problematic mealtime behaviors (e.g., not staying seated and showing aggressive 
behaviors or tantrums during mealtime) and food selectivity (i.e., only eating a narrow 
variety of foods), compared to their neurotypical peers, which may increase the risk for 
developing poor eating behaviors and inadequate nutrient intakes.9 Lower intakes of 
protein, calcium, phosphorus, riboflavin, and vitamin B12 have been reported in children 
with ASD.9 Due to these feeding problems, parents’ attempts to expand their children’s 
diets may be more challenging. Therefore, interventions for this population should 
address ASD-specific feeding challenges.  

 
Page 6 of 26 
Revised: 10/24/2022 
 
Early childhood nutrition interventions have shown promise of improving eating 
behaviors and slowing weight gain in typically developing children,10,11  but their 
effectiveness is understudied among children with developmental disabilities. Currently, 
there is no evidence on whether an early childhood nutrition intervention emphasizing 
both ASD-specific mealtime behaviors and healthy eating behaviors has benefits of 
mitigating problematic eating behaviors and developing healthy dietary habits for 
children with ASD. Our study proposes to explore whether early childhood is an optimal 
time period for starting nutrition intervention and the long-term goals is to examine how 
dietary risk factors can be managed in early childhood to improve health trajectories in 
population with ASD. 
 
3.2 We pilot-tested the intervention with a small number of EI providers and parent-child 
dyads (n=5) to examine how intervention components fit with the Part C service setting. 
Preliminary fidelity and provider interview data indicated that the intervention manual 
was easy to follow and has potential to be widely implemented in the EI services, 
indicating a good fit.12 Participants further suggested innovative ways to improve the 
intervention such as adding more hands-on activities, booster sessions, and social media 
components. 
 
1. 
Maenner MJ, Shaw KA, Baio J, et al. Prevalence of Autism Spectrum Disorder 
Among Children Aged 8 Years — Autism and Developmental Disabilities 
Monitoring Network, 11 Sites, United States, 2016. Morbidity and mortality 
weekly report Surveillance summaries. 2020;69(4):1-12. 
2. 
Xu G, Strathearn L, Liu B, Bao W. Prevalence of Autism Spectrum Disorder 
Among US Children and Adolescents, 2014-2016. JAMA. 2018;319(1):81-82. 
3. 
Xu G, Strathearn L, Liu B, et al. Prevalence and Treatment Patterns of Autism 
Spectrum Disorder in the United States, 2016. JAMA Pediatr. 2019;173(2):153-
159. 
4. 
Tyler CV, Schramm SC, Karafa M, Tang AS, Jain AK. Chronic disease risks in 
young adults with autism spectrum disorder: forewarned is forearmed. Am J 
Intellect Dev Disabil. 2011;116(5):371-380. 
5. 
Berry RC, Novak P, Withrow N, et al. Nutrition Management of Gastrointestinal 
Symptoms in Children with Autism Spectrum Disorder: Guideline from an Expert 
Panel. J Acad Nutr Diet. 2015;115(12):1919-1927. 
6. 
Burrell TL, Sharp WG, Criado KK, et al. Feasibility of a Structured, 
Multidisciplinary Intervention for Weight Management in Children With Autism 
Spectrum Disorder. Seminars in Pediatric Neurology. 2020;35:100830. 
7. 
Curtin C, Hyman SL, Boas DD, et al. Weight Management in Primary Care for 
Children With Autism: Expert Recommendations. Pediatrics. 2020;145(Suppl 
1):S126-S139. 
8. 
Evans EW, Must A, Anderson SE, et al. Dietary Patterns and Body Mass Index in 
Children with Autism and Typically Developing Children. Res Autism Spectr 
Disord. 2012;6(1):399-405. 

 
Page 7 of 26 
Revised: 10/24/2022 
 
9. 
Sharp WG, Berry RC, McCracken C, et al. Feeding problems and nutrient intake 
in children with autism spectrum disorders: a meta-analysis and comprehensive 
review of the literature. J Autism Dev Disord. 2013;43(9):2159-2173. 
10. 
Hodder RK, Stacey FG, Wyse RJ, et al. Interventions for increasing fruit and 
vegetable consumption in children aged five years and under. Cochrane Database 
Syst Rev. 2017;9:CD008552. 
11. 
Scott-Sheldon LAJ, Hedges LV, Cyr C, et al. Childhood Obesity Evidence Base 
Project: A Systematic Review and Meta-Analysis of a New Taxonomy of 
Intervention Components to Improve Weight Status in Children 2-5 Years of Age, 
2005-2019. Child Obes. 2020;16(S2):S221-s248. 
12. 
Van Arsdale W, Gray H, Buro A. P150 Development of an 8-Week Early 
Childhood Nutrition Education Intervention for Children with Autism Spectrum 
Disorder and their Parents. Journal of Nutrition Education and Behavior. 
2020;52(7, Supplement):S87. 
 
4.0 
Study Intervention  
4.1 Autism Eats intervention (Table 1): Lessons integrate ASD-specific feeding strategies 
such as escape extinction, food chaining, and making regular mealtime routines and 
behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal 
planning, monitoring progress, strategies to overcome barriers, and creating healthy home 
food environment. The EI providers are well-trained to use personalized intervention and 
coaching approach in their EI services, which will be applied to Autism Eats activities as 
well (e.g., using the child’s favorite foods for lesson activities). There is no content 
difference between in-person and telehealth versions of the program, except those 
instructions for providers are tailored to in-person vs. telehealth settings. 
 
Table 1. Components of Autism Eats nutrition intervention 
Components 
Example Activity 
Lessons: topics and objectives 
 
L1. Feeding Milestones:  
Understand feeding milestones for infants and toddlers. 
Feeding milestone 
screening  
L2. Sensory Properties of Foods: Taste, Flavors, & Textures:  
Explore the role of senses as it pertains to taste, flavor, 
and texture in the development of food preferences. 
Exploring senses 
activity 
L3. Introducing New Foods:  
Understand and utilize strategies for introducing new 
foods into the child’s diet. 
Repeated exposure 
L4. Balanced Eating and Nutrition:  
Examine the benefits of healthy foods and learn how to 
integrate them in a daily menu. 
Creating a meal plan  
L5. Food Allergies, Special Diets, and Supplements:  
Food sorting activity 

 
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L = Lesson 
 
EUC control group materials are from the evidence-based materials that are already 
developed and available online (in both English and Spanish): 
https://www.nhlbi.nih.gov/health/educational/wecan/index.htm  
We will download one handout for each week and email EI providers to distribute for 
parent-child dyads who are randomly assigned into the EUC group.  
 
5.0 
Procedures Involved 
5.1  
Aim 1: The EI providers (n=10) and parents (n=10) will be invited to review the 
intervention manual and materials and provide their feedback. Participants will receive a 
survey link for the manual review which is described in 5.2 below. Based on the results 
of the review, all intervention materials will be further refined and finalized.  
 
Understand food allergies, special diets, and 
supplements that may affect or be beneficial for their 
child. 
L6. Beverages:  
Identify age-appropriate beverages and examine the 
benefits of healthy beverage selection. 
Family beverage goal 
setting 
L7. Mealtime Routines and Schedules: 
Establish a mealtime routine and create a consistent 
eating schedule. 
Mealtime routine 
L8. Restructuring Food Environment:  
Develop strategies to make healthy choices and have a 
pleasant experience while eating outside the home. 
Strategies for eating 
out 
L9. Hunger and Fullness Cues:  
Build confidence in recognizing when the child is 
hungry or full. 
Responding to 
hunger and satiety 
L10. Maintaining Healthy Nutrition:  
Create long-term strategies to sustaining healthy eating 
habits. 
Restructuring the 
home food 
environment 
Booster L1. Where are We Now?: 
Review previous lessons and discuss barriers for 
healthy eating and ways to overcome them.  
Goal reinforcement  
Booster L2. Celebrating Achievements 
Celebrate healthy eating achievements with positive 
reinforcement.  
Positive 
reinforcement 
practice 
Static website repository  
Project description and lesson resources 
Handouts available 
online 
Social media 
Private social media (Facebook) group page  
Extra motivational 
resources and parent 
engagement  

 
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Aim 2: The protocol for this project is designed to 
conduct a preliminary RCT. This pilot RCT 
compares Autism Eats (n=24 parent-child dyads) 
to the EUC condition using We Can! materials 
(n=24 parent-child dyads). EI providers (n=30) in 
two Florida counties (Hillsborough and Polk 
Counties) will be recruited on a rolling basis and 
parent-child dyads will be recruited through those 
EI providers. Baseline assessment will be 
scheduled. Study participants will be randomized 
into two intervention groups (Autism Eat and EUC 
We Can!) after collection of the baseline data. 
Random assignment will be conducted by Kim 
(Co-I) utilizing a random number generator. 
Participants in Autism Eats will receive the 
intervention components while those in the EUC 
group receive comparison We Can! materials. Data 
collection will be performed at three time points. 
Study design is also described in Figure 1. 
 
5.2 
☒ Audio/Video Recording 
☐ Psychophysiological Recording 
☒ Behavioral Interventions 
☐ Record Review - Educational 
☐ Behavioral Observations and Experimentations 
☐ Record Review - Employee 
☐ Deception 
☐ Record Review- Medical  
☐ Focus Groups 
☐ Record Review - Other 
☒ Interviews 
☐ Specimen Collection or Analysis 
☐ Investigational Device – Non-Significant Risk 
(e.g. Mobile Applications) 
☒ Surveys and/or Questionnaires 
☐Psychometric Testing 
☐ Other Social-Behavioral Procedures 
Aim 1: We will invite EI provides and parents to review the intervention manual and 
materials and provide their feedback. The review invitation will be sent out through an 
online survey link (RedCap).  
For EI providers, the feasibility scale used in our pilot study will be used. Seven 
questions will address feasibility of implementing each lesson, clarity of instructions, 
relevance to the EI services, acceptability by parents, satisfaction of resources/references, 
and clarity and relevance to the overall goal. Open-ended questions on each lesson will 
allow EI providers to share recommendation regarding each session’s content and 
materials. The manual review will take up to 3 hours per participant.  
Figure 1. Study design 

 
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For parents, the feasibility scale will be tailored to parent participants and address 
clarity of instructions, acceptability, satisfaction of intervention materials, and feasibility 
of implementing feeding practices at home. Open-ended questions on each lesson will 
allow parents to share recommendation regarding each session’s content and materials. 
The survey will take about 1-2 hours per participant. 
Aim 2: We will track the number of EI providers and parents reached by the recruitment 
methods. We will monitor and document reasons for dropping out, and clearly indicate 
whether it was the provider or the parent who decide to drop out. Completion rates of 
assessments at all data collection time points, training sessions, and lesson and booster 
lesson implementation will be tracked and recorded.  
Training session materials include a 90-minute presentation prior to the 
intervention implementation and a 90-minute mid-training session in-between lesson 4 
and 8. Both training sessions have been developed and pilot-tested in our preliminary 
feasibility study, and all enrolled EI providers participated in those sessions without 
attrition. On-going EI provider support will be provided by offering co-coaching the 
sessions when the EI providers need assistance on nutrition-specific activities. Randomly 
selected sessions (20%) will be observed and check whether all lesson components are 
consistently implemented as designed across EI providers, adapting the 5-point scale 
from a previous clinical trial. We will examine whether our intervention sessions fit the 
context of the EI services as well as the needs, expectations, and values of the EI 
providers, using an exit survey. Using those selected sessions, compatibility of the 
intervention content and activities for different levels of children’s autism features and 
symptoms will also be examined from the observation or video-recorded sessions. EI 
providers and parents will be invited for a semi-structured interview at 5-month follow-
up. The interviews will be audio/video recorded for transcriptions. 
Three-day food record is a gold-standard assessment for dietary intake of 
individuals. Three 24-hour food records will be completed by parents using the NCI’s 
Automated Self-administered 24-Hour Dietary Recall. Research assistants (RA) will 
provide guidance as needed. We focus on average daily dietary intakes by food groups 
(i.e., fruit, vegetables, grain, protein, and dairy) and daily food variety. For all children 
aged 2 years or older, diet quality will be determined by the Healthy Eating Index’s total 
and sub-component scores (adequacy vs. moderation food categories). The Brief Autism 
Mealtime Behavior Inventory (BAMBI) will be used to assess children’s mealtime 
behaviors. The BAMBI is a validated assessment tool that contains 18 questions and uses 
a 5-point Likert scale. A trained RA (single-blinded) will assess children’s height and 
weight with a professional stadiometer and a weight scale following the standardized 
protocol used in previous studies. As a standard weight status assessment for birth to 36 
months, weight-for-length based on the CDC growth chart will be calculated. Parent BMI 
will be calculated and used as a covariate in data analysis. If height and weight 

 
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information is available for the spouse of the participating parent or the other biological 
father/mother, it will be recorded. Questions on sex, race/ethnicity, family history of 
ASD, age, parental education, income, insurance status, and history of other illnesses and 
comorbid health conditions such as epilepsy, sleep disorders, and anxiety disorders will  
be asked at baseline. We will also administer the Child Feeding Questionnaire, a 
validated questionnaire used in our multi-site nutrition intervention clinical trial. 
 
5.3 Our comparison group will receive an enhanced usual early intervention service.  
Enhanced Usual Care (EUC) Comparison. A one-time 25-minute session on nutrition 
(modified lesson 4 of the Autism Eats) will be embedded in the regular EI services. The 
EUC EI providers will receive one 30-minute training session on EUC content and 
activities. To maintain scientific control for attention threats and increase rigor, EUC 
families will also receive publicly available web-based information on healthy eating 
using We Can! materials weekly over 10-weeks by email to correspond with the number 
of Autism Eats sessions. We Can! is evidence-based nutrition and physical activity 
materials from the National Heart Lung and Blood Institute 
(https://www.nhlbi.nih.gov/health/educational/wecan/index.htm). We will also send out 
two monthly booster information by email. 
 
5.4 Potential risks are minimal. Participants may experience psychological discomfort 
during intervention sessions or while answering survey questions or having their 
height and weight measured. To protect against risk, research procedures will be 
explained, and any questions will be answered. The risks and benefits of participation 
will be described before obtaining a signed IRB-approved informed consent from EI 
providers and parents, respectively. Children younger than 3 year old cannot complete 
assent form, so parents will sign the consent forms for their children and for 
themselves. No pressure will be exerted on the subjects to participate, and they have 
the right to withdraw from the study at any time. Research personnel will be told to 
report any untoward participant reactions directly to the research project coordinator 
and the PI. Minor concerns raised by providers and parents (e.g. embarrassment about 
being weighed) will be addressed by the research staff. Participants will be carefully 
monitored using the resources of the University of South Florida, a research institution. 
Dr. Gray and Dr. Stern each bring extensive experience working with the development 
and evaluation of behaviorally-focused interventions targeting dietary behaviors to 
children. The research team will be available to refer any participants to appropriate 
specialists as necessary. EI providers and parents will be told that they can terminate 
their participation in the study at any time with no penalty. 
5.5 N/A 
 
5.6 N/A 

 
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5.7 There will be post intervention (2.5-3 months after baseline measurements) and 5-
month follow-up assessment as described in Table 4 below.  
 
*T1: baseline; T2: post intervention; T3: 5-month follow-up 
 
6.0 
Data and Specimen Storage for Future Research 
6.1 Data will be collected and maintained in accordance with legal and ethical standards 
and will be centrally stored in a master database. RedCap is a secure web application for 
research studies in HIPAA compliant environments, which will be used to collect data, 
except the dietary intake data that will be collected through the ASA24 online system. 
RedCap will allow for data to be entered and uploaded to a central, secure database, 
while prohibiting access outside USF. Providers and parents will be emailed a link to the 
RedCap-based surveys. 
Only principal investigator and study staff members will have access to files 
containing identifiers such as contact information of study participants (providers and 
parent-child dyads). These files will be stored in an encrypted form in a password 
protected secure database. These files will be used only for data collection. The collected 
data will be deidentified. Participants’ information that individuals can be identified with 
will be removed from the study data files. The deidentified data will be stored as study 
data files in a password protected USF computer in a locked USF office. 
For data security and confidentiality of study data files, we will develop data 
management and security policy that all users of the study data should adhere to. Only 
authorized users can have access to and possess the data files to conduct data analyses. 
Authorized users include principal investigator, study data managers, study data analysts. 
Other internal users and external users should be given authorization by the principal 
investigator. All users must sign a data security agreement and send a copy of the 
agreement to the principal investigator. Users should not share a copy of study data files.  
All users must adhere to the data security and confidentiality procedures. All users other 
than principal investigator and study data managers must destroy study data files upon 
the completion of a study as specified in the agreement.   
Table 4. Efficacy Outcomes 
 
Outcomes 
Measures / Expected Outcomes 
Time 
Dietary intake 
3-day food records (ASA24TM) / Food intakes (e.g., fruit and vegetables ↑), daily 
food variety ↑, diet quality (e.g., HEI fruit ↑, vegetables ↑, plant protein ↑) 
T1, 2,3 
Mealtime behaviors 
Brief Autism Mealtime Behavior Inventory16 via REDCap / Problematic behaviors 
↓. 
T1,2,3 
Weight status 
(height and weight) 
A stadiometer/ruler and a scale; birth to 36 months, weight-for-length%tile based 
on the CDC growth chart.17 BMI for parents 
T1 & 3 
Feeding behaviors 
Child Feeding Questionnaire via REDCap 
T1 & 3 
Demographics 
A survey through the REDCap. 
T1 
Health conditions 
Family history of ASD and comorbid health conditions such as epilepsy, sleep 
disorders, and anxiety disorders through the REDCap. 
T1 & 3 

 
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6.2 The final dataset will include self-reported demographic, dietary, and behavioral data 
from 3-day food records, a validated mealtime behavior questionnaire, and a survey. 
Obesity exploratory outcome data will be collected with children’s and parents’ height 
and weight. All datasets will be de-identified with numeric numbers. 
 
6.3 We will make the data and associated documentation available to users under a data-
sharing agreement that provides for: (1) a commitment to using the data only for research 
purposes such as a review of similar intervention studies and not to identify any 
individual participant; (2) a commitment to securing the data using appropriate computer 
technology; and (3) a commitment to destroying or returning the data after analyses are 
completed. Our aggregated data and results will be available through ClinicalTrial.gov 
following their requirement and guidelines. 
 
7.0 
Sharing of Results with Subjects 
7.1 Because the proposed study is a preliminary efficacy study (Stage 1 clinical trial), 
without clear understanding of the intervention content and context, the data can be 
misinterpreted. Thus, results will not be shared with anyone outside the research team or 
without a data-sharing agreement. 
 
8.0 
Study Timelines 
8.1 Activities for Aim 1 will start in October 2021 and Aim 2 is planned to be started in 
January 2022. The project will end in July 2023. Participants will be recruited in a rolling 
basis. For Aim 2 (RCT), each parent-child dyad will have three data collections: baseline 
(T1), post-intervention (T2), and 5-months follow-up from baseline (T3). The Enhanced 
Usual Care (EUC) comparison group will receive one intervention session and periodic 
written materials from We Can!.  
 
9.0 
Inclusion and Exclusion Criteria 
9.1  
Level 1 – Early Intervention (EI) service providers:  
Inclusion criteria: Full-time employees of EI services who have children with ASD in 
their service at the time of recruitment are eligible to participate.  
 
Level 2 – Parent-child dyads:  
Inclusion criteria:  
• Children should be enrolled in the EI service. Children who are determined as “at 
risk/monitored for ASD” at the time of screening or diagnosed with ASD 
determined by clinical assessment such as the Autism Diagnostic Observation 
Schedule (ADOS) or another validated evaluation tool such as Gilliam Autism 
Rating Scale (GARS-3). Children birth to 36 months are eligible for the EI 

 
Page 14 of 26 
Revised: 10/24/2022 
 
services, and therefore, age of our research participants will range from birth to 36 
months.  
• Parents should be 18 years or older and speak fluent English and/or Spanish 
9.2  
Level 1 – Early Intervention (EI) service providers:  
Exclusion criteria: Non-EI service providers and who do not work with children with 
ASD. 
 
Level 2 – Parent-child dyads:  
Exclusion criteria:  
• Children who are on exclusive breastfeeding, medicines that may interact with 
appetite and food consumption, having severe GI conditions such as irritable 
bowel syndrome, diagnosed with feeding disorders or severe food selectivity, or 
other serious medical comorbidities such as cancer.  
• Parent and child with ASD who have previously participated in a similar nutrition 
intervention study will also be excluded. 
• Parent’s first language is not English or Spanish.  
 
9.3 If participants are diagnosed with other serious illnesses or medication condition 
other than ASD, they will be excluded from the study. The intervention and EUC 
program will be implemented within the EI service schedules. EI providers and parent-
child dyads work closely together within their regular EI programs regardless their 
participation status in our study. If either an EI provider or parent-dyad wish to withdraw 
from the study, it is likely that they will discuss and made a decision together.      
 
9.4 The study will include employees from the USF Florida EI program, Early Steps, 
since the USF Early Steps EI providers will be recruited. 
 
10.0 Vulnerable Populations 
10.1 Children from birth to 36 months diagnosed with ASD. All efforts will be made to 
safeguard the children with ASD. Children’s privacy and confidentiality will be 
protected, as will their rights, safety, and well-being. The intervention materials have 
been written to address  mealtime and eating behaviors in children with ASD and a pilot 
study was conducted in this population. As mentioned, the possible risks of the study are 
minimal. The direct and potential benefits outweigh the risks of the intervention. 
Resources and specialists will be made available to parent-child dyads who experience 
any adverse reactions, e.g., discomfort answered questions about dietary behaviors or 
being weighed by the research staff. 
 
11.0 Local Number of Subjects 
11.1  

 
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For Aim 1, 10 EI providers and 10 parents will be enrolled.  
For Aim 2, 30 EI providers and 48 parent-child dyads (48 parents and 48 children) will 
be enrolled. 
12.0 Recruitment Methods 
12.1  
 
12.2 
For aim 1, the EI providers and parents will be recruited through the county EI services. 
The research team members will send out emails to the EI directors and ask them to 
distribute the flyers to EI providers. The EI service directors/administrators/providers will 
distribute the parent flyer to potentially eligible parents. Anyone who is interested in 
participating in the study will be asked to contact the research team. 
 
For aim 2, EI providers and parent-child dyads will be recruited through email and flyer 
as described below. 
Early Intervention (EI) service providers: Providers will be first recruited through the EI 
program that covers Hillsborough and Polk Counties in Florida. There are approximately 
180 EI providers in these two counties. The director of the EI services in these counties is 
a Co-I of this study. A recruitment flyer emphasizing the importance of early nutrition 
intervention and common mealtime behavioral problems among children with or at 
risk/monitored for ASD will be distributed by email and through appropriate social media 
platforms (e.g., Facebook). Trained research staff and/or the PI will conduct a brief 
introductory session at one of the regular provider meetings to introduce the study and 
use a sign-up sheet to recruit potential providers who are willing to participate in the 
study. Recruitment materials will be distributed repeatedly until the target participant 
number is met. 
 
Parent-child dyads: EI providers who agree to participate will inform potentially eligible 
parents about the study and recruit them to contact the research team for study 
participation. A parent recruitment flyer will be distributed through the EI services and/or 
directly by the EI providers to eligible parents.  
 
12.3 For vulnerable population described in section 10, at the intake and then subsequently 
at the time of each follow-up assessment, participants are reminded that they may 
discontinue any procedure at any time, or withdraw from the study altogether, without 
☒ Email 
☐ Online/Social Media Advertisement 
☒ Flyer 
☐ Record Review 
☐ Letter 
☐ SONA 
☐ News Advertisement 
☐ Other  

 
Page 16 of 26 
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prejudice, and afforded opportunities to ask questions about any facet of the study. We take 
great care to assure that neither participants nor their families feel any coercion to take part 
in the project, and that participation in the study is a positive and affirming experience for 
those who do take part. Study participants are assured that they are free to withdraw at any 
time without prejudice and will still receive the same quality of services. 
 
13.0 
Withdrawal of Subjects 
13.1 Withdrawals without participants’ consent are not anticipated. 
 
13.2 We will contact participants who withdraw by email to ask the reason for 
withdrawal and conduct an interview if possible. To manage dropout, we will first assess 
whether dropout was related to certain baseline measures and demographic variables. We 
will report dropout rate and compare distributions of baseline measures and demographic 
variables.  
 
14.0 Risks to Subjects 
14.1 Potential risks are minimal. Participants may experience psychological discomfort 
during intervention sessions or while answering survey questions or having their height 
and weight measured. All survey measures are online, and a virtual session will be 
available for participants’ height and weight measurement, considering the risks 
associated with COVID-19. For program implementation, EI providers will adhere to 
their organizational recommendations and procedures for COVID-19 safety measures. 
Our program can be implemented in person or through telehealth with the manual that 
include detailed instructions for both modalities. Therefore, participants won’t have an 
increased risk for getting COVID-19 based on their status of study participation. 
Participants will still be informed that, there is a risk of transmission of the novel 
coronavirus if they participate in any research activities in person, and that while 
precautions will be taken, we cannot guarantee that the participant will not be exposed to 
the virus.  
 
14.2 N/A 
 
14.3 N/A 
 
15.0 Potential Benefits to Subjects or Others 
15.1 Autism Eats may prevent problematic mealtime behaviors and promote 
development of healthy eating habits among children with ASD. Participants may 
benefit from increased awareness of health factors related to foods that might 
improve their ability to manage their health in the future. Thus, it is possible that 
the proposed study will advance the well-being of the participants. Professional 

 
Page 17 of 26 
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development sessions for EI providers can benefit the providers by training them 
about the Autism Eats nutrition intervention and healthy eating behaviors in 
general. 
 
15.2 This novel and timely study may establish potential feasibility and preliminary 
efficacy of an EI-integrated nutrition intervention that if proven effective could 
substantially reduce lifetime risk for diet-related chronic conditions among children with 
ASD. The findings may benefit the field of health promotion, especially promoting health 
eating habits among children with ASD, by identifying whether an innovative nutrition 
intervention through the Part C EI services can improve participants’ dietary behaviors, 
problematic mealtime behaviors, and potentially weight status. The benefits of the study 
to the children with ASD, and to society at large appear to justify the minimal risks. 
Findings from this study will provide relevant information to determine appropriate 
nutrition intervention to promote healthy eating behaviors for birth to 36 months children 
with ASD, a developmentally critical period. In addition, if we found any positive 
trends/outcomes related to obesity as tested in our exploratory aim, this can inform the 
field of obesity and chronic disease prevention research, significantly relevant to public 
health. 
 
16.0 Data Management and Confidentiality 
16.1  
Aim 1: Descriptive statistics for quantitative data (i.e., mean, standard deviation, 
frequency and percentages) and content analyses for qualitative data (i.e., theme coding) 
will be performed based on information collected from the questionnaires. 
 
Aim 2: Descriptive analyses of baseline characteristics and outcomes will include means 
and standard deviations for continuous variables and frequencies for categorical 
variables. Treatment compliance will also be evaluated. The primary analysis will be 
conducted based on the intent-to-treat principle. Distributional assumptions will be 
checked, and appropriate transformations or non-parametric methods will be applied as 
necessary.  
Aim 2a. Test the feasibility of enrollment, implementation, and evaluation of 
Autism Eats. Descriptive statistics will be used to examine data distributions and 
frequencies. If there is substantial variability in attrition, completion, fidelity, and 
compatibility, we will examine the relations of such variables with any other variables we 
collect during the study such as demographic variables of EI providers and parent-child 
dyads.   
Aim 2b. To assess the preliminary efficacy of Autism Eats on child dietary intake 
and mealtime behaviors. We will examine variance and effect sizes of key outcomes from 
pre- to post-intervention, as well as post-intervention to 5-month follow-up using non-

 
Page 18 of 26 
Revised: 10/24/2022 
 
parametric tests and confidence intervals. We will first assess whether Autism Eats and 
EUC groups are balanced through randomization in terms of demographic variables at 
baseline. For each outcome variable, we will use boxplots and scatterplots with 
confidence intervals to visually inspect the changes across pre-intervention, post-
intervention, and 5-month follow-up by group along with descriptive statistics. Also, 
nonparametric longitudinal analysis will be conducted for each outcome variable with 
time as a within-subject factor and treatment condition as a between-subject factor to 
examine the difference in changes between Autism Eats and EUC groups. 
Exploratory Aim. We will explore whether weight status of children are different 
between Autism Eats and EUC groups at 5-month follow-up assessment. Descriptive 
statistics and visual inspection will be used to summarize weight status by group and 
effect sizes will be computed. Similar to the analysis of the primary outcomes, we will 
conduct nonparametric analysis to compare the changes in weight status at 5-month 
follow-up between Autism Eats and EUC groups. Note that parent BMI will be included 
as a covariate in the analysis. 
 
16.2 Data will be collected and maintained in accordance with legal and ethical standards 
and will be centrally stored in a master database. RedCap is a secure web application for 
research studies in HIPAA compliant environments, which will be used to collect data, 
except the dietary intake data that will be collected through the ASA24 online system. 
RedCap will allow for data to be entered and uploaded to a central, secure database, 
while prohibiting access outside USF. Providers and parents will be emailed a link to the 
RedCap-based surveys. 
Only principal investigator and study staff members will have access to files 
containing identifiers such as contact information of study participants (providers and 
parent-child dyads). These files will be stored in an encrypted form in a password 
protected secure database. These files will be used only for data collection.  
The collected data will be deidentified. Participants’ information that individuals 
can be identified with will be removed from the study data files. The deidentified data 
will be stored as study data files in a password protected USF computer in a locked USF 
office.  
For data security and confidentiality of study data files, we will develop data 
management and security policy that all users of the study data should adhere to. Only 
authorized users can have access to and possess the data files to conduct data analyses. 
Authorized users include principal investigator, study data managers, study data analysts. 
Other internal users and external users should be given authorization by the principal 
investigator. All users must sign a data security agreement and send a copy of the 
agreement to the principal investigator. Users should not share a copy of study data files.  
All users must adhere to the data security and confidentiality procedures. All users other 
than principal investigator and study data managers must destroy study data files upon 
the completion of a study as specified in the agreement.   

 
Page 19 of 26 
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The study statistician (Kim) will work closely with the PI (Gray) to ensure that 
the research team adhere to the data management procedures and security plan.  
 
The Aim 2 study parent-child data will be submitted to the National Institute of 
Mental Health Data Archive (NDA) at the National Institutes of Health (NIH) as required 
for all NIH funded research studies collecting data from individuals with ASD. NDA is a 
large database where deidentified study data from many NIH studies are stored and 
managed. Sharing deidentified study data helps researchers learn new and important 
things about brain science more quickly than before. During and after the study, the study 
researchers will send deidentified study data about participants’ health and behavior to 
the NDA. Other researchers across the world can then request the deidentified study data 
for different research projects. Every researcher (and the institution to which they belong) 
who requests the deidentified study data must promise to keep the data safe and promise 
not to try to learn participant identity. Experts at the NIH who know how to keep the data 
safe will review each request carefully to reduce risks to the participant privacy. Sharing 
the study data does have some risks, although these risks are rare. The study data could 
be accidentally shared with an unauthorized person who may attempt to learn 
participant’s identity. The study researchers will make every attempt to protect the 
participant identity. NIMH will also report to Congress and on its website about the 
different studies using NDA data. The study participants will not be contacted directly 
about the study data submitted to NDA.  
 
The study participants may decide that they do not want their study data to be 
added to NDA. They can still participate in this research study even if they decide that 
they do not want the data to be added to NDA. If any participants decide any time that 
they do not want the data to be added to NDA, we will let them call or email the study 
staff, and we will inform NDA to stop sharing the study data. Once the data is part of 
NDA, the study researchers cannot take back the study data that were shared before they 
were notified. The participants are informed about NDA on the consent form and the 
research staff will be explained through the informed consent process. Detailed NDA 
information is available on-line at http://nda.nih.gov.  
 
16.3 Review of the rate of subject accrual and adherence to inclusion/exclusion criteria 
will occur monthly during the recruitment period. This will assure that participants will 
meet eligibility criteria and ethnic diversity goals outlined in the grant application. 
 
Data type 
Frequency of review 
Subject accrual (adherence to protocol regarding 
demographics, inclusion/exclusion) 
Monthly 
Adverse events  
As they happen 
Adverse events rates  
Bimonthly 

 
Page 20 of 26 
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Compliance to intervention 
Bimonthly 
Stopping rules regarding statistical power, 
implications of dropouts, and missing data 
Semiannually 
 
16.4   
All datasets will be de-identified with numeric numbers. The PI will have ultimate 
responsibility for ensuring participant well-being and for the integrity of data collection 
in the proposed study. The confidentiality of information provided by participants will be 
safeguarded by the use of participants’ code numbers. In addition, all data will be stored 
in a locked file cabinet, and project staff will be instructed to maintain the participants’ 
anonymity. All measurement protocols are well established in our research center and 
pose minimal risk. The data safety monitoring plan (DSMP) involves monitoring by the 
PI in conjunction with a safety officer from University of South Florida Institutional 
Review Board. There will be periodic reports by the project coordinator and Dr. Gray on 
data collected by the research team. 
Only principal investigator and study staff members will have access to files 
containing identifiers such as contact information of study participants (providers and 
parent-child dyads). These files will be stored in an encrypted form in a password 
protected secure database. These files will be used only for data collection.  
The collected data will be deidentified. Participants’ information that individuals 
can be identified with will be removed from the study data files. The deidentified data 
will be stored as study data files in a password protected USF computer in a locked USF 
office.  
For data security and confidentiality of study data files, we will develop data 
management and security policy that all users of the study data should adhere to. Only 
authorized users can have access to and possess the data files to conduct data analyses. 
Authorized users include principal investigator, study data managers, study data analysts. 
Other internal users and external users should be given authorization by the principal 
investigator. All users must sign a data security agreement and send a copy of the 
agreement to the principal investigator. Users should not share a copy of study data files.  
All users must adhere to the data security and confidentiality procedures. The study 
records and data will be maintained for 5 years after completion of the research, and will 
be destroyed based on the USF data disposal procedure and regulations. 
 
16.5  
☒Obtaining Signed Authorization 
☒Waiver of HIPAA Authorization for 
Recruitment/Screening Purposes Only 
☐Obtaining Online or Verbal Authorization 
(Alteration of HIPAA Authorization) 
☐Waiver of HIPAA Authorization for 
Entire Study 
☒Data Use Agreement 
☐Business Associate Agreement 

 
Page 21 of 26 
Revised: 10/24/2022 
 
• 
For Aim 1 of the study, we will not collect any PHI from participants. For Aim 2 
of our study, children’s clinical diagnosis of ASD or at risk/monitored for ASD is 
considered as a PHI because we will need to collect the ASD diagnosis or at 
risk/monitored for ASD status from the USF Epic. All USF Early Steps members 
have access to USF Epic and a liaison person to our research will verify the ASD 
diagnosis or at risk/monitored for ASD status under supervision of the director 
and co-investigator Dr. Shaffer-Hudkins. If the ASD diagnosis was performed 
outside the USF clinics or Early Steps program, the Early Steps usually have the 
information in file. We will ask the Early Steps to provide us with the ASD 
diagnosis or at risk/monitored for ASD status information for each child to 
confirm the eligibility before we obtain informed consent from the parents. We 
will not collect any PHI from the EI providers. Our parent consent/permission 
form for Aim 2 includes HIPAA language to indicate that such information is 
obtained for the purpose of the study.  
• 
Inclusion criteria: The recruitment letters and flyers  have the eligibility criteria 
about children’s ASD diagnosis or at risk/monitored for ASD status. Children 
aged 0-36 months who are clinically diagnosed with ASD or at risk/monitored for 
ASD status within the Early Steps and their parents are eligible to participate in 
this study. After the EI providers shared the parent recruitment letter with the 
parents who are potentially eligible, parents who are interested in the study will 
contact the project coordinator or the principal investigator. Then, to determine 
children’s eligibility before USF research staff obtain signed consent from 
parents, we will obtain a PHI (ASD diagnosis or at risk/monitored for ASD status) 
from the Early Steps program as described above. Therefore, we need to request a 
waiver of HIPAA authorization for recruitment/screening purposes only. 
• 
Time interval: ASD diagnosis and at risk/monitored for ASD status verification 
process will be done twice: (1) one at the beginning of the enrollment process, 
prior to obtaining parent’s informed consent; and (2) the other at the 5-month 
follow up assessment to capture any changes in ASD diagnosis or at 
risk/monitored for ASD status. The time interval between the ASD diagnosis 
verification and parent consent will be approximately 1-7 days. The second 
verification will be done around the time when the dyads complete the 5-month 
follow up assessment.   
• 
Plan to protect identifiers: We will obtain the ASD diagnosis or at 
risk/monitored for ASD status PHI with de-identified numeric numbers. Study 
IDs and matched parent names will be separately provided to the Early Steps (see 
“ID and parent name tracking sheet.xlsx”). The Early Steps liaison staff will 
confirm the ASD diagnosis by looking up their USF Epic records and complete 
the ASD diagnosis tracking sheet using only the ID numbers without participants’ 
names. The liaison staff will record ASD diagnosis or at risk/monitored for ASD 
status including who diagnosed ASD and determined at risk/monitored for ASD 
status, date of the evaluation, level of ASD (if reported), autism diagnostic 
observation schedule (ADOS) or alternative scale score (if reported), and child’s 
age at diagnosis or evaluation date on “Early Steps ASD diagnosis tracking 
sheet.xlsx”). This ASD diagnosis tracking sheet does not include identifiable 
information. Only principal investigator and study staff members will have access 

 
Page 22 of 26 
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to the file containing identifiers (the ID and parent name tracking sheet), which 
will be stored separately from other data in a password protected secure database. 
They will be kept in a secure in Box that is HIPAA compliant. 
• 
Plan to destroy: For individuals who agree to participate, their information will 
be kept as part of their research file and will be signing an authorization allowing 
for this information to be included in the research. Any PHI from those who are 
not eligible to participate or refuse to participate will be destroyed immediately.  
• 
Written assurance: The PHI (ASD diagnosis or at risk/monitored for ASD 
status) will not be reused/disclosed to any other person or entity except as 
required by law, for authorized oversight of the research project, or for other 
research which use/disclose of PHI would be permitted by the HIPAA privacy 
regulations. Only de-identified data may be used for other research.  
• 
Why is not practicable to obtain signed HIPAA Authorization: For Aim 2 of 
our study, the HIPAA waiver for screening and recruitment is needed to verify 
ASD diagnosis or at risk/monitored for ASD status prior to obtaining signed 
consent. After screening, signed authorization will be obtained through the parent 
consent/permission.  
• 
Why study cannot be conducted without access to PHI (ASD diagnosis or at 
risk/monitored for ASD status): By collecting information from USF Epic 
regarding child’s ASD diagnosis or at risk/monitored for ASD status, level of 
autism, and date of diagnosis/evaluation, we will obtain the most accurate 
information about clinical ASD assessment and diagnosis. The HIPAA waiver for 
screening and recruitment is needed to verify ASD diagnosis or at risk/monitored 
for ASD status prior to obtaining signed consent. There are cases with other 
developmental delays or disabilities such as down syndrome within the Early 
Steps programs. Because children with or at risk/monitored for ASD status 
experience specific mealtime and eating challenges and our intervention is 
designed to address those specific challenges, we need to know that children are 
diagnosed or at risk/monitored for ASD status prior to obtaining signed consent.  
• 
For Aim 2 of study, parent-child study data will be submitted to NDA as 
described in section 16.2. with Data Use Agreement completed by the PI and 
USF: NIH-funded studies with human subjects who are diagnosed with ASD are 
required to submit deidentified data about health and behaviors of participants. 
Complying with this requirement, we have submitted the Data Use Agreement 
(DUA) and signed the Data Submission Agreement (DSA) on the NDA system. 
Any identifiable information will not be submitted to the NDA system.   
17.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
17.1 An adverse event (AE) is any untoward medical occurrence that is temporally 
associated with participation in the clinical study. A serious adverse event (SAE) is any 
adverse event that results in one or more of the following outcomes: death, life-
threatening event, inpatient hospitalization or prolongation of existing hospitalization, 
persistent or significant disability/incapacity, congenital anomaly or birth defect, 
significant medical event based on clinical judgment.  

 
Page 23 of 26 
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AE severity will be graded by severity (mild, moderate, or severe) depending on 
the intensity of the event for the participant. An AE will be termed 'mild' if it does not 
have a major impact on the participant, 'moderate' if it causes the participant some minor 
inconvenience and 'severe' if it causes a substantial disruption to the participant’s well-
being. A participant can have a severe event that is not a SAE and a moderate event that 
meets the SAE definition. AE’s will also be categorized according to the likelihood that 
they are related to the study intervention as: definitely, probably, possibly, or unrelated to 
the study intervention. SAEs that are unanticipated or possibly related to the study 
intervention will be reported to the Safety Officer at IRB and PI as they happen, and to 
the IRB, Clinical Research Center (CRC) and NIH within two weeks. Anticipated SAEs 
or those unrelated to the study intervention will be reported to the Safety Officer and PI 
as they happen, and to the IRB, CRC and NIH on a monthly basis. 
There are multiple health professionals within the early intervention services. We 
will refer the subject to an appropriate professional counselor to address any adverse 
effect(s). 
 
17.2 N/A  
 
18.0 Provisions to Protect the Privacy Interests of Subjects 
18.1 All research activities will be conducted in private setting/platform with EI 
providers or research staff.  
 
18.2 Subjects will provide informed consent.  
 
19.0 Compensation for Research-Related Injury 
19.1 N/A  
 
20.0 Subject Costs and Compensation 
20.1 There will be no cost incurred because of study participation that are over and above 
the costs that would be incurred from standard care or services. 
 
20.2  
 
 
• Aim 1: Each EI provider and parent will receive $50 for reviewing the intervention 
manual and materials. 
☐No Compensation 
☐Tokens (pens, food items, etc.) 
☒Financial Compensation (cash, gift cards) 
☐Other  
☐Course Credit (i.e. extra credit, SONA 
points) 
 

 
Page 24 of 26 
Revised: 10/24/2022 
 
 
• Aim 2: For both the Autism Eats intervention and We Can! EUC control groups, 
o Each EI provider will be compensated for the following activities, 
• First training session: a $50 gift card 
• Second training session in the mid-point: a $50 gift card 
• Completing intervention implementation: a $50 gift card 
• Exit interview: a $50 gift card.  
• Total amount: $200 
 
o Each parent-child dyad will be compensated for the following activities, 
▪ Baseline assessment: a $50 gift card 
▪ Post intervention assessment: a $60 gift card 
▪ 5-month follow-up assessment: a $70 gift card 
▪ Exit interview: a $50 gift card  
▪ Total amount: $230  
 
• If any providers or parents participate in both Aim 1 and Aim 2 research activities, 
the maximum amount a provider can get from this study is $250, and the maximum 
amount a parent-child dyad can get from this study is $280. All participants (EI 
providers and parents), in both the intervention and EUC control group, will receive 
the same compensation schedule. There is no difference between the parent-child 
dyad intervention and control groups as it pertains to schedule.  
 
21.0 Consent Process 
21.1  
 
21.2  
The signed consent will be used for Aim 2 for both EI providers and parents. The consent 
process will be completed remotely.  
 
EI provider consent process: EI providers who are interested in the study will contact 
the PI or the project coordinator. The project coordinator or a trained research assistant 
☒Obtaining Signed Consent (Subject or 
Legally Authorized Representative) 
☒Obtaining Consent Online (Waiver of 
Written Documentation of Consent ) 
☒Obtaining Signed Parental Permission 
☐Obtaining Verbal Consent (Waiver of 
Written Documentation of Consent) 
☐Obtaining Signed Assent for Children 
or Adults Unable to Consent 
☐Waiving Consent and/or Parental Permission 
(Waiver of Consent Process) 
☐Obtaining Verbal Assent for Children or 
Adults Unable to Consent 
☒Waiving Assent/Assent is Not Appropriate 

 
Page 25 of 26 
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will schedule a phone or virtual Teams meeting to explain detailed research activities and 
go over the consent form together. The consent document will be emailed to each 
participant in advance and for them to keep. Once the project coordinator or the research 
assistant answer or clarify any questions that the provider has, the project 
coordinator/research assistant will send an electronic signature form to the provider via 
DocuSign.  
Parent consent process: Parents will provide consent for study participation. Once EI 
providers indicate that one of their parents who have a child with or at risk/monitored for 
ASD and enrolled in the EI program is interested in participating in the study, the parent 
will contact the PI or the project coordinator to schedule a phone call or virtual Teams 
meeting. The project coordinator or a trained research assistant will explain detailed 
research activities and go over the combined parental consent and permission with the 
parents. The consent document will be emailed to each participant in advance and for 
them to keep. Once the project coordinator or the research assistant answer or clarify any 
questions that the parent has, the project coordinator/research assistant will send an 
electronic signature form to the parent via DocuSign.  
 
Aim 2 research activities explained in the consent form:  
• EI providers: signed consent form 
o Attending training sessions 
o Implementing intervention 
o Completing fidelity checklist 
o Exit interview virtually through Microsoft Teams 
• Parents: signed consent form  
o Dietary intake assessment virtually through Microsoft Teams 
o Mealtime behavior, demographic, and health conditions questionnaires 
through online survey platform (REDCap) 
o Height and weight measurement 
o Exit interview virtually through Microsoft Teams 
21.3  
The consent online (waiver of written documentation of consent) will be used for aim 1 
for both EI providers and parents.  
 
EI providers and parents who are interested in the study will contact the PI or the project 
coordinator. The project coordinator or a trained research assistant will assess the 
eligibility and explain the study procedure via a preferred method by the participant (e.g., 
email, phone call, virtual meeting), and send the REDCap survey link to the participant 
including the consent document. Participants will be asked to proceed with the survey by 
clicking the “next” button on the page if they agree to participate, or they will be asked to 

 
Page 26 of 26 
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leave the survey page. All participants will have access to the copy of consent document 
via email, REDCap, or file attachment in the virtual meeting. 
 
Aim 1 research activities explained in the consent form: 
• EI provider/parent manual review. Feedback from the EI providers and parents 
will be collected through online survey platform (REDCap) 
 
21.4 N/A  
 
21.5 Once the English consent document is approved by the IRB, the study team will 
submit an amendment to obtain approval for the Spanish consent document. The Spanish-
speaking research staff will be responsible for translating the consent from English to 
Spanish. A separate independent translator who has no knowledge of or contact with the 
original text will translate the consent back from Spanish to English. The project 
coordinator or trained research assistant will then assess the two versions to see if they 
are consistent. Approved translated consent form will be used by the Spanish-speaking 
research staff to obtain consent from all Spanish-speaking participants.  
 
21.6 The children to be enrolled are from birth to 36 months diagnosed with or at 
risk/monitored for ASD status and cannot provide consent. Parental permission will be 
obtained from parent participants.  
 
22.0 Setting 
22.1 The study will be conducted at the USF College of Public Health (single site). The 
Florida EI service is called Early Steps. There are 15 Early Steps programs in Florida and 
the USF Early Steps program covers two counties (Hillsborough and Polk Counties). EI 
providers and parents from the USF Early Steps program in these two counties will be 
recruited for both Aim 1 and 2 of the study. For Aim 2, participants will be involved in 
weekly Autism Eats sessions or one EUC session through their regular EI services. The 
EI providers from the USF Early Steps program will be recruited on a rolling basis and 
parent-child dyads will be recruited through those EI providers. The director of the USF 
Early Steps program is a Co-investigator of the project (Dr. Emily Shaffer-Hudkins) and 
there will be a project liaison staff person who will be paid to assist with the study 
recruitment and communication. Dr. Shaffer-Hudkins participated in protocol writing and 
has attended monthly project meetings since August 2021. All decisions regarding 
recruitment and participant engagement have been discussed with Dr. Shaffer-Hudkins 
and approved by her. Any further changes will be discussed with Dr. Shaffer-Hudkins at 
regular research team meetings.