Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment
Phase: NA
Conditions: Autism Spectrum Disorders
Sponsor: Emory University

 
 
 
 
Title: Changing Developmental Trajectories through Early Treatment 
 
 
NCT Number: NCT01985022 
 
Protocol Date: 10/19/2020 
 
 

 
1.  
Full title: Changing Developmental Trajectories through Early Treatment 
 
Short title: Early Treatment Interaction 
 
 
Investigators:  Nathan Call (PI) 
 
 
 
Jennifer Stapel-Wax (Investigator) 
 
 
 
Celine Saulnier (Investigator) 
 
 
 
Amy Wetherby (PI) 
 
 
 
Juliann Woods (Investigator) 
 
 
 
Date: 10/19/2020 
 

 
2.  
Abstract: 
The overarching goal of this research protocol is to identify the health and developmental 
implications for age of screening and age of entry into early intervention for children at risk of 
Autism Spectrum Disorder (ASD). With increased number of young children identified with ASD, 
there is a pressing need for evidence-based, manualized, cost-efficient treatments that are 
accessible to and feasibly implemented by parents within their natural environments in 
community-based settings. Additionally, significant disparities in diagnosis and treatment of ASD 
have been found in racial and ethnic minority populations thereby increasing the need for 
families from diverse cultural and socioeconomic backgrounds. The major objective of this 
research protocol is to directly compare two parent intervention conditions of Early Social 
Interaction (ESI) for 9 months on developmental trajectories of infants showing early risk for 
ASD. The control treatment is an information, education and support group (Group) offered 
weekly; the experimental treatment is a parent-implemented intervention (Individual) offered in 
2 weekly individualized sessions to teach parents how to embed strategies that support social 
communication skills, emotional regulation, and transactional supports skills within everyday 
routines, activities, and places, in combination with Group. This protocol will recruit 92 parent-
infant dyads at 12 months of age from both the high and low risk siblings being studied in the 
Emory Autism Center of Excellence Projects 1 and 2. High risk infants will screen positive on 2 of 
4 screening measures indicating the presence of diagnostic features of ASD by 12 months of age. 
Low risk infants who screen positive on 2 of 3 screening measures at the 12 month visit will 
receive a subsequent home observation measure. Any children who screen positive on this 
measure will qualify for treatment. Families will be randomly assigned through the process of 
minimization to either Group or Group and Individual for 9 months. The specific aims of this 
investigation are:  Aim 1) Effectiveness of Treatment – to compare the effectiveness of Group 
+Individual on developmental trajectories of social communication, autism symptoms, social 
visual engagement, developmental skills, and adaptive behavior, compared to Group alone; Aim 
2) Mediators of Treatment – to determine whether growth trajectories of child active 
engagement and parent transactional support are mediators of response to intervention; and 
Aim 3) Moderators of Treatment – to identify individual child and family characteristics which 
predict response to intervention. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
3.  
Introduction and Background 
 
Mounting evidence exists of the effectiveness of intensive early intervention for a substantial 
proportion of children with autism spectrum disorders (ASD; Dawson & Osterling, 1997; 
National Research Council (NRC), 2001). Furthermore, age of entry into intervention may be 
predictive of outcome. Children with ASD in intensive interventions beginning by 3.5 years of 
age had significantly better outcomes than those after age 5 (Fenske, Zalenski, Krantz, & 
McClannahan, 1985; Harris & Handleman, 2000). These findings support the importance of early 
identification and intervention for improving outcomes. These findings also support the 
importance of addressing the significant disparities in diagnosis and treatment of ASD that have 
been found in some populations. Families of racial/ethnic minority, lower levels of education, 
and those who live in non-metropolitan areas have been found to experience greater limitations 
in accessing services for ASD (Thomas, Ellis, McLaurin, Daniels, & Morrissey, 2007). Black and 
Hispanic children have been found to have lower odds of having a documented ASD 
classification than white children (Mandell, Wiggins, Arnstein Carpenter, Daniels, Durkin et al., 
2009) and of those children who do receive an ASD diagnosis, many of them are not diagnosed 
in early childhood. The age of first ASD diagnosis received has been found to be significantly 
older for African American and Latino children compared to white children (Mandell, Listerud, 
Levy, & Pinto-Martin, 2002). For these reasons, it is important that the effectiveness of intensive 
early intervention for children with ASD is examined across varying cultural and socioeconomic 
backgrounds.  
Importance of Evidence-Based Early Intervention for Children with ASD 
The NRC (2001) conducted a systematic research review on educational interventions for 
children with ASD and concluded that a large body of research has indicated significant progress 
in response to intervention with a substantial proportion of children. The committee concluded 
that there is a convergence of evidence that the following characteristics are essential active 
ingredients of effective interventions for children with ASD: 
1) entry into intervention programs as soon as ASD is suspected;  2) active engagement in 
intensive instruction for a minimum of five hours per day, five days a week;  3) use of repeated 
planned teaching opportunities structured over brief periods of time;  4) sufficient 
individualized adult attention on a daily basis;  5) inclusion of a family component, including 
parent training;  6) mechanisms for ongoing assessment with corresponding adjustments in 
programming; and 7) priority for instruction on a) functional, spontaneous communication; b) 
social instruction across settings; c) play skills with a focus on peer interaction; d) new skill 
maintenance and generalization in natural contexts; and e) functional assessment and positive 
behavior support to address problem behaviors.  Building on the efforts of the NRC 
committee, a NIMH working group developed guidelines for designing research studies of 
psychosocial interventions for children with ASD (Smith et al., 2007). They delineated steps for 

developing, validating, and disseminating interventions and made two recommendations to 
guide investigators and help funding agencies identify important needs and standardize criteria: 
1) resources should be dedicated to support manual development and effectiveness studies of 
manualized interventions; and 2) new interventions should be developed and tested to address 
core features of ASD. Furthermore, the Interagency Autism Coordinating Committee Strategic 
Plan for ASD stresses that to further the development of such interventions, research should 
include 1) the application of methods from an established treatment paradigm to a diverse 
community setting; 2) the collection of information about the model of delivery, intensity, and 
duration for interventions targeting families with limited resources; and 3) the collection of first-
hand insights and perspectives of family members and caregivers of children with ASD that will 
inform intervention research addressing the needs of diverse populations. 
Meaningful Intervention Outcome Measures for Very Young Children with ASD 
Research conducted over the past two decades has identified core deficits in joint attention, 
shared affect, and conventional and symbolic aspects of communication and play in young 
children with ASD. It has also shown that these deficits are significant predictors of 
developmental outcomes (Mundy, Sigman, & Kasari, 1990; Sigman & Ruskin, 1999; Stone, 
Ousley, Yoder, Hogan, & Hepburn, 1997; Wetherby, Prizant, & Hutchinson, 1998; Wetherby, 
Watt, Morgan, & Shumway, 2007; Wetherby et al., 2004). Several very recent publications 
reporting on studies of infant siblings have documented that delays in social communication are 
evident by 12 to 14 months of age in younger siblings who later receive a diagnosis of ASD 
(Landa, & Garrett-Mayer, 2006; Mitchell et al., 2006; Zwaigenbaum et al., 2005). These findings 
provide further support that children with ASD can be identified and distinguished from children 
with developmental disorders and typical development before 18 months of age. 
Thus, social communication skills are important intervention outcome measures for children 
with ASD. Although a large number of studies have delineated core deficits associated with ASD, 
very few have documented the effects of interventions on these deficits (NRC, 2001). In a 
multiple-baseline-design study involving four children with ASD, Whalen and Schreibman (2003) 
demonstrated that changes in initiating and responding to joint attention can be systematically 
taught using pivotal response training. In a randomized-group-design study, Aldred, Green, and 
Adams (2004) implemented a monthly parent-training program for 14 preschool children 
compared to 14 children in a community-treatment control group. They found significantly 
lower Autism Diagnostic Observation Schedule (ADOS) scores, indicating fewer autism 
symptoms in the treatment group, and significantly better outcomes regarding parental positive 
synchronous communication and rate of child communicative acts; however, they found no 
significant difference between the two groups in number of episodes in which the parent and 
child shared attentional focus. Aldred et al.’s results suggest that significant gains in some 
aspects of social communication can be achieved by teaching parents how to enhance their 
children’s communication in a cost-effective treatment, but gains in joint attention may require 
a more intensive or different approach to intervention. 
Meaningful changes that reflect core social communication deficits in children with ASD still 
need to be documented. Current research has indicated that multiple aspects of social 
communication need to be measured to better characterize this population. Even studies of the 
most effective treatments for children with ASD have shown variable outcomes (NRC, 2001), 
and a child’s social communication skills before treatment may influence the response to 

treatment. Little is known about the potential impact of interventions that target the social 
communication skills of children with ASD younger than 3 years of age. 
Most studies reviewed by the NRC included children 3 to 5 years of age. There is very limited 
research on children with ASD under 3 years of age primarily because the median age for 
diagnosis in the US based on record review is 5.5 years (Shattuck et al., 2009). Two studies 
support the application of the NRC recommendations for younger children. McGee, Morrier and 
Daly (1999) reported good verbal outcomes of 28 toddlers with ASD in a center-based incidental 
teaching program. Since they did not have a control group, it is not possible to sort out 
treatment effects from maturation and other confounding variables or determine whether this 
sample of children with ASD is representative. Stone and Yoder (2001) found a strong positive 
association between the number of hours of speech therapy received between the ages of 2 and 
3 and language skills at age 4 in 35 toddlers with ASD. These findings suggest that beginning 
intervention before age 3 may have a greater impact than later intervention. With advances in 
earlier screening and diagnosis, there is a pressing need to develop early intervention programs 
that are appropriate and effective with very young children with ASD. 
The Early Social Interaction Project 
Providing intervention of adequate intensity for young children with ASD is challenging for the 
healthcare and education systems. Services delivered by professionals within Part C of the 
Individuals with Disabilities Education Improvement Act of 2004 (IDEA; PL 108-446; USDOE, 
2004) average 2-3 hours per week (NEILS). Only a few states have designated intensive services 
for children with ASD; services in these states may be as high as 20+ hours per week. Providing 
intervention in the natural environment is a way to maximize learning throughout the day and 
enhance generalization using routines, materials, and people common to the family and child 
(Dunst, Hamby, Trivette, Raab, & Bruder, 2000; Woods Cripe & Venn, 1997). Training parents to 
implement intervention strategies during everyday activities is a logical method for achieving 
the intensity of active engagement recommended by the NRC (2001). The effectiveness of 
parent-implemented interventions for children with developmental disabilities has been well-
established. However, only a small number of studies have included children with ASD, and 
those studies are on children 3 years of age or older. 
The Early Social Interaction (ESI) Project is an intervention program developed for toddlers at 
risk for ASD and their families as a model demonstration project funded by the U.S. Department 
of Education. ESI was designed to incorporate the NRC recommendations within the context of a 
family-centered, natural-environments approach, which is considered recommended practice 
for delivery of IDEA Part C services. Following are the major components of ESI (Woods & 
Wetherby, 2003): 
1. Routines-Based Intervention in Natural Environments: The provision of support and 
intervention in natural environments to enhance the child’s participation in everyday routines 
and the family’s participation in community activities. Routines and activities important to each 
family become the context for the intervention.  2. Individualized Curriculum: The curriculum 
is individualized for the child’s unique profile. A developmental framework that targets social 
interaction, joint attention, communication, imitation, play, and emotional regulation guides the 
curriculum-based assessment process (Prizant, Wetherby, & Rydell, 2000) to establish goals for 
the child.  3. Parent-Implemented Intervention: Interventionists teach families to create 

learning opportunities and use specific intervention strategies to practice the child’s goals within 
daily routines. Collaborative problem-solving allows the family members to take advantage of 
teaching opportunities throughout the day, to feel confident about their abilities to engage the 
child in meaningful activities, and to facilitate social communication skills. 
Based on the steps delineated by Smith et al. (2007), we have: 1) developed an intervention 
manual to standardize the critical treatment components of ESI with protocols for implementing 
and evaluating the manualized intervention, 2) conducted single-subject design studies on the 
intervention strategies, and 3) conducted feasibility testing of ESI with a group of 17 families 
(Wetherby & Woods, 2006). Our findings are presented in the Preliminary Studies section of this 
proposal. The next step recommended by Smith et al. is a multi-site randomized clinical trial to 
test the efficacy of the intervention, which is the aim of the proposed research study. 
Interaction of Core Deficits of ASD, Brain Development, and the Learning Environment 
Neuroplasticity, a developmental mechanism that reflects the brain’s capacity to be molded by 
the environment (Pascual-Leone, Amdei, Fregni, & Merabet, 2005), is heightened in the first few 
years of life, and diminishes with age. The 2nd year of life is a time period associated with 
developmental regression in children with ASD (Rogers, 2004). Regression in children with ASD 
has been documented in language and communication and other developmental domains for 
21% to 48% of children with ASD (Davidovitch, Glick, Holtzman, Tirosh, & Safir, 2000; Goldberg 
et al., 2003; Lord, Shulman, DiLavore, 2004) and occurs most often between 18 and 21 months 
of age (Goldberg et al., 2003; Shinnar et al., 2001). The findings on developmental regression are 
compelling in relation to recent brain research which has suggested that there is an overgrowth 
of the brain of children with ASD over the first few years of life. Studies of head circumference 
and brain volume have indicated enlargement in individuals with autism that may be restricted 
to early childhood (Courchesne et al., 2001; 2003; Lainhart et al., 1997; Piven et al., 1996; Sparks 
et al., 2002; Stevenson et al., 1997). Significant brain volume enlargement has been found in a 
study of children with autism from 2-4 years that was not present in participants in the 5-16 
year age range (Courchesne et al., 2001; Piven et al., 1996). Although the processes leading to 
increased brain volume are not yet known, these studies suggest that the timing of brain 
enlargement in children with ASD is consistent with an underlying mechanism that diminishes 
the normal process of dendritic pruning (Huttenlocher, 1990). Synaptogenesis in the cortex is 
characterized by overproduction of synapses in the first months of life followed by pruning that 
extends into the preschool period (Huttenlocher & Dabholkar, 1997). Studies of experience-
dependent synaptogenesis conducted on rats reared in complex environments showed more 
mature synaptic structure and more synapses per neuron (Black & Greenough, 1998; Greenough 
& Black, 1992). An important implication of these findings is that early intervention could have 
enduring effects on human brain development and the impact of those effects may be time-
limited. The research of Landry et al. (Landry, Smith, Swank, & Loncar, 2000; Landry, Smith, 
Miller-Loncar, & Swank, 1998) suggests a critical or sensitive period early in children’s 
development. 
While it is known that ASD is a neurobiological disorder, current theories emphasize the 
interaction of abnormal brain development, the child’s social communication profile, and the 
learning environment. Mundy and Burnette (2005) suggested that an initial neurological deficit 
in infants with autism leads to an early impairment in social orienting and joint attention, which 
contributes to subsequent neurodevelopmental pathology by an attenuation of social input. 

This transactional process can lead to a cumulative spiraling that may compromise subsequent 
neurological and behavioral development or possibly be ameliorated through early intervention. 
Core deficits that have been identified in the 2nd year of life may attenuate the quality of social 
input of children with ASD very early in life and through a transactional process have a cascading 
effect on later developmental outcome and autism symptoms (Wetherby et al., 2007). In other 
words, the symptoms of ASD may further disrupt brain development and this disruption may be 
cumulative. Developmental regression may reflect this process. Because of the transactional and 
cumulative detrimental impact on brain development, these core social deficits may be critical 
targets for early intervention in order to enhance social communication skills likely to impact the 
social environment, and thus, lead to better outcomes for children with ASD. This leads to the 
question of whether very early intervention can prevent or attenuate the subsequent cascading 
effect on neurodevelopment and behavioral outcomes that potentially arise from early 
impoverished social interactions in the 2nd year of life. Very early intervention may be viewed 
as a mechanism to prevent the full unfolding of symptoms of ASD by minimizing the associated 
secondary abnormalities in brain development. 
National Significance of the Need for Improving Early Detection of ASD 
Although there have been significant advances in genetic and biomedical research on ASD, there 
is currently no biological marker for autism or ASD. Consequently screening and diagnosis of 
ASD must be based on behavioral features (Filipek et al., 1999). The Centers for Disease Control 
(CDC) has initiated the “Learn the Signs. Act Early.” campaign to alert health care professionals 
and parents to the early signs of ASD. Several screening tools for ASD are currently being studied 
and offer promise (Robins, Fein, Barton, & Green, 2001; Stone, Coonrod, Turner, & Pozdol, 
2004; Wetherby et al., 2004). Despite such campaigns, rates of early diagnosis remain low, 
particularly in racial and ethnic minority populations and in families of lower socioeconomic 
status (Mandell et al., 2009; Mandell & Novak, 2005). When parents or caregivers do voice 
concerns early, many primary care providers take a “wait and see” stance because interventions 
for intervention protocols for young children are still relatively new and not all physicians are 
yet aware of the positive impact . There is a critical need to document whether early 
intervention beginning in the 2nd year of life leads to better outcomes than beginning in the 3rd 
year of life. Such findings may be able to define a critical window in the 2nd year to screen for 
ASD and to provide the impetus to urge primary care providers to refer very young children for a 
diagnosis of ASD and early intervention. 
National Significance of the Need for Improved Early Intervention for Children with ASD 
Most children with ASD require special education at school age. The average annual cost for 
educating a child with ASD, based on 2005 figures from the US Government Accountability 
Office, is $18,800, compared to $12,500 for the average special education student and $6,556 
for a regular education student. Additionally, a recent study by the Harvard School of Public 
Health shows that the annual cost of caring for a child with autism is upwards of $67,000 (Ganz, 
2007). With effective early intervention services, the future is more promising. We know that 
providing intervention early has a greater impact; between 60 and 90% of children in intensive 
early intervention programs beginning by age 3 can learn to talk, and about half can make it into 
regular kindergarten, compared to 10% without early intervention (NRC, 2001). Documenting 
that early intervention provided in the 2nd year of life can lead to better outcomes would have 
very important ramifications for substantially reducing the cost of education. 

 
4.  
Objectives 
There is a pressing need to improve early detection of autism spectrum disorders (ASD) because 
research indicates that earlier intervention maximizes children’s outcomes (National Research 
Council, 2001). In spite of the severity of the behavioral characteristics of ASD, the median age 
for diagnosis in the US based on record review is 5.5 years (Shattuck et al., 2009) far past the 
window of opportunity for early intervention. The average delay between initial evaluation and 
diagnosis of ASD was 13 months in a study of surveillance records (Wiggens, Baio, & Rice, 2006). 
Closing the gap in time between initial parent concern, initial evaluation, and age of diagnosis 
would greatly reduce the age of entry into intervention. The American Academy of Pediatrics 
(AAP) recommends that all children be screened for autism at the 18- and 24-month visits 
(Johnson & Myers, 2007). Ongoing research on early markers of ASD will lower the window for 
the possibility of early detection to infancy, heightening the need for interventions that are 
effective and appropriate for infants and very young toddlers. The AAP practice guidelines and 
the new Interagency Autism Coordinating Committee Strategic Plan for ASD Research make the 
need for early intervention that is feasible to implement in community-based settings a high 
priority.  
In response to RFA-HD-12-195, this treatment project is designed to address two 
significant public health challenges- the need for validated, manualized treatments for young 
children with ASD that are cost-efficient and feasible for community-based implementation, and 
the need to reduce the age of entry into early intervention. The major objective is to directly 
compare two parent intervention conditions for 9 months: 1) an information, education and 
support group (Group) offered weekly, and 2) an individualized parent-implemented 
intervention (Individual) offered in 2 weekly sessions to teach parents how to embed strategies 
to support social communication skills within everyday routines, activities, and places. The 
Emory ACE Center will recruit 92 parent-infant dyads at 12 months of age from theboth  high 
and low risk siblings being studied. Inclusion criteria for high risk infants will be a positive screen 
on 2 of 4screening measures indicating the presence of diagnostic features of ASD by 12 months 
of age. Inclusion criteria for low risk infants will be a positive screen on 2 of 4  screening 
measures indicating the presence of diagnostic features of ASD by 12 months of age.  Families 
will be randomly assigned to either Group or Group +Individual for 9 months. Outcome 
measures of social communication, autism symptoms, developmental level, and adaptive 
behavior will be gathered every 6 months from 12 to 36 months of age to measure treatment 
and follow-up effects. Measures of parent transactional support and child active engagement 
will be collected monthly beginning at 12 months until 36 months of age to examine change in 
developmental trajectories.  
This project is conceptualized as a series of research questions (RQ) for each specific aim 
to examine the effects of intervention on outcomes of toddlers with ASD. The specific aims and 
research questions are:  
Aim 1. Effectiveness of Treatment:  To compare the effects of Group alone to Group plus 
Individual implemented from 12 to 21 months of age on outcome measures of social 
communication skills, autism symptoms, developmental levels, and adaptive behavior 
from 12 to 36 months. Research will address specific questions with regard to whether 
there are: RQ1a) differences in growth trajectories from 12 to 36 months on social 
communication skills and autism symptoms, and RQ1b) differences in trajectories of 
developmental level and adaptive behavior from 12 to 36 months for children receiving 

Group alone versus Group plus Individual for 9 months from 12 to 21 months of age. 
Although the treatment group may qualify at 12 months of age, treatment bay begin up to 
age 15 months. 
Aim 2. Mediators of Treatment:  To determine whether parent transactional support and child 
active engagement are mediators of response to intervention. Specific research questions 
will address whether: RQ2a) there are differences in trajectories of parent’s use of 
transactional supports and child’s level of active engagement during everyday activities 
with their child during intervention and follow-up booster sessions until 36 months of age 
for parents participating in Group alone and Group +Individual, and RQ2b) the degree of 
parent transactional support and child active engagement predict change in children’s 
social communication skills and severity of autism symptoms between at 18, 24 and 36 
months of age. 
Aim 3. Moderators of Treatment:  To identify individual child and family characteristics which 
predict response to intervention. Specific research questions will address: RQ3a) what 
moderator variables predict response Group, and RQ3b) what moderator variables predict 
response to Group +Individual? 
The expected outcomes of this study will have the following important implications: 1) 
documentation of improved outcomes for very young toddlers with ASD receiving a manualized, 
community-based, cost efficient, appropriate, and effective intervention; 2) evidence that 
parent individualized intervention beginning by 12 months of age leads to better outcomes than 
group education and support; and 3) substantiation of the critical need for screening and 
identification of ASD in the 2nd year of life, rather than waiting until the 3rd year or later, because 
this may be a crucial developmental period for effective early intervention. 
 
5.  
Study Design, Methods and Participant Selection 
Sample Recruitment. 92 parent-child dyads will participate in this study. The Emory ACE 
Center will recruit 92 parent-infant dyads at 12 months of age from the pool of 230 “High-Risk 
for Developing ASD” younger siblings and from the pool of 100 low risk infants being studied. 
Inclusion criteria for high-risk infants will be a positive screen on 2 of 4 screening measures  
indicating the presence of diagnostic features of ASD by 12 months of age. In addition, one of 
these positive screens must be a SORF measure. Inclusion criteria for low-risk infants will be a 
positive screen on 3 of 4 screening measures, including positive screens on both SORF measures.  
It is important to note that a diagnosis of ASD cannot be made reliably at 12 months of age but 
early signs will be evident in children who will end up with ASD, the broader autism phenotype 
(BAP), or developmental delay (DD). The Clinical Assessment Core will follow children and 
clinical diagnosis will be confirmed at 36 months of age. 
The following screening protocol will be used with infants at 9 and 12 months of age. The 
procedures and records for the screening protocol are part of the Clinical Assessment Core and 
are covered in a separate IRB application. All 230 infants will be given the Infant-Toddler 
Checklist (ITC) a broadband parent report screen for communication that has norms and cut 
scores at each month from 6 to 24 months of age and has been documented to detect children 
with ASD down to 9 months of age. Infants who have a positive screen on the ITC will be given 
the following three autism-specific screening tools: 1) Early Screening for Autism and 
Communication Disorders (ESAC), an autism-specific parent report screen with 35 recognition 
format or closed-choice items and 6 open-ended items; 2) Systematic Observation of Red Flags 
(SORF) Clinic, the SORF rating from the CSBS (see Clinical Assessment Core), Behavior Sample 
from a video recording of a structured observation in a clinical setting; and 3) SORF-Home, the 

SORF rating from the home observation of the parent engaged in interaction with the child in 
everyday activities (meals and snacks, caregiving, play with toys or objects, play with people, 
book sharing, and family chores. The ESAC and SORF were chosen because these are the only 
empirically-supported screening tools for ASD at this age. FSU has extensive experience 
conducting screening and diagnostic evaluations of infants and toddlers using these tools and 
will oversee selection of referrals for this study. For high-risk infants, the selection criterion for 
participation in this treatment study is a positive screen on 2 of the 4 autism-specific screening 
tools with one of those positive screens being a SORF. For low-risk infants, selection criteria for 
participation includes a positive screen on both SORF measures and one additional measure 
(e.g., 3 out of 4 measures). The purpose of this early treatment study is to contribute to the 
overarching aims of the Emory ACE Center to study risk and resilience in ASD. Therefore, we are 
targeting infants who are genetically at risk and who show early signs of autism and 
communication delay. Thus, we are casting a broader net than only children who will end up 
with a diagnosis of ASD but are selecting siblings who are at the highest risk for having ASD or a 
developmental delay. 
Random Assignment of Participants to Experimental Groups. Children who meet the 
selection criteria and whose parents give consent to participate in the study will be given a 
computer-generated random assignment to one of two groups- Group plus Individual or Group 
alone. As a complement to random assignment, we will covary pretest variables that end up 
being correlated with the outcome variables, in our statistical analysis, if the groups are not 
equivalent on these variables. The diagnosticians for all measures and raters for intervention 
fidelity and treatment mediators will be kept blind to group assignment.  
Sample Retention and Attrition. Our strategies to promote retention are particularly geared 
for families with environmental risks and include: 1) assisting families in filling out 
questionnaires and maintaining frequent contact to remind them about returning forms and 
upcoming appointments; 2) coordination of appointments with other agencies; 3) offering small 
financial incentives to compensate for their time for assessment visits; 4) offering families an 
hour a month of consultation to provide information needed about ASD and to coordinate 
referrals to other agencies; and 5) to provide the 2 weekly Individual sessions in the home and 
incorporate the families’ everyday activities. Because the Group only group is at a greater risk 
for attrition, we have made an effort to design that treatment to be appealing to families by 
offering it weekly and have limited the length to 9 months. In Georgia, the public Part C early 
intervention programs for children under 36 months do not offer specialized or intensive 
services for children with autism or ASD. Like the majority of states, non-categorical eligibility 
based on developmental delay is customary and the usual services provided in these states are 1 
to 3 hours of clinician-implemented therapy per week. Thus, it is anticipated that both groups 
will utilize the community services comparably and that because of the low intensity of 
community services, they are not anticipated to diffuse Individual treatment effects, and may 
actually contribute to retention in this study. That is, families will be motivated to participate in 
Group or Individual as a supplement to community services. Because the parents of children in 
this study have an older sibling with ASD, they will be more motivated to participate in early 
intervention for the high-risk sibling showing early diagnostic features of ASD. We anticipate a 
possible attrition rate between 10 and 12%. With this attrition rate, we will complete 
intervention for at least 80 children.  
 
Timeline for Assessment Measures and Intervention Activities.  
Infants will be recruited during Years 2 and 3 of the Emory ACE, 46 children in each year totaling 
92 children. Children will be followed until 36 months of age and follow up assessments will be 

completed during years 3-5. The timeline for assessment measures and intervention activities is 
included in Appendix 1. 
 
Dependent Variables [CAC= Emory ACE Clinical Assessment Core (IRB#65732)] 
The following dependent variables will be collected by the CAC and coded by raters blind to 
treatment condition before treatment at 12 months and again at 24 months and 36 months of 
age. Additionally, the Social Communication Measures will be completed at 15 months and 21 
months of age for all children enrolled into the Early Social Interaction project. 
Social Communication Measures. The Communication and Symbolic Behavior Scales (CSBS) 
Behavior Sample will be video recorded to measure social communication. Reliability and 
validity of the CSBS has been reported (see CAC). The raw scores will be summed to form a 
social, speech, and symbolic composite. 
Autism Symptoms. The Autism Diagnostic Observation Schedule (ADOS) (see CAC) is the gold 
standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted 
Repetitive Behavior ratings of autism symptoms will be used.  
Developmental Levels. The Mullen Scales of Early Learning MSEL (see CAC) measures 
developmental level with separate scores for four cognitive scales that form an early learning 
composite. A nonverbal DQ based on age equivalent divided by chronological age multiplied by 
100 will be calculated from the average of the Fine Motor and Visual Reception scales and a 
verbal DQ will be calculated from the Receptive and Expressive Language scales.  
Adaptive Behavior. The Vineland Adaptive Behavior Scales VABS-II (Survey Interview Form; see 
CAC) yields a standard score in four domains— Communication, Daily Living, Social, and Motor, 
and an Adaptive Behavior Composite.  
Expressive Language Phase. The child’s expressive language phase will be determined at each 
assessment based on the benchmarks delineated by Tager-Flusberg and colleagues and 
recommended for evaluating the efficacy and comparing outcomes across NIH-funded 
intervention studies. Based on multiple sources of information about language benchmarks, the 
language will be categorized as: Preverbal Communication, First Words, Word Combinations, or 
Sentences, to provide a clinically meaningful measure of language outcome. 
 
Mediator Variables 
The home observation measure will be collected monthly as the context to chart developmental 
trajectories of mediator variables. This context provides an hour of parent-child interaction 
during a variety of everyday activities in the natural environment without the clinician present 
and is an index of generalization of parent and child learning over the course of the treatment 
study. It is hypothesized that parent implementation of transactional supports is a mediator of 
child active engagement, which is a mediator of treatment outcome. These mediators will be 
evaluated from the monthly home observations with the Measure of Active Engagement and 
Transactional Supports (MAETS; see Appendix 2) at baseline through 36 months of age. 
Specifically, these home observations will be completed monthly during the 9 month 
intervention period and then quarterly through the child’s 36 month birthday. It is also 
hypothesized that the measures available through Projects I and II, of social visual and vocal 
engagement, are mediating variables, and will be examined in relation to the MAETS and 
outcomes on dependent variables for children in the two treatment conditions. 
 
Moderator Variables 
Demographic Information. Parents will be asked to provide demographic information about 

race, ethnicity, and socioeconomic level as possible moderators of treatment effect. (see CAC) 
Baby Siblings Research Consortium Intervention History Form. The number of hours of other 
intervention outside of ESI will be documented and updated by a parent monthly. This form 
documents the hours in psychosocial or educational treatments and whether the child is 
receiving alternative treatments (e.g., diet, chelation). The total number of hours per week of 
combined therapies and intervention multiplied by the number of weeks received will be 
calculated. (see Appendix 2) 
Parent Questionnaires about Family Functioning. Parents will complete the following 
questionnaires at baseline and every 6 months until 36 months of age: ESI Home and 
Community Activities form to measure how many activities the parent participates in and how 
their child with ASD impacts their participation. Family Impact Questionnaire to measure 
parent’s perception of the impact of their child on the family; Family Resource Scale to measure 
the adequacy of physical and human resources available to the family; Parenting Daily Hassles  
to measure minor daily stresses experienced by parents in routine tasks involving child rearing; 
Parenting Sense of Competence (see CAC) to measure parents’ sense of competence with their 
child; and Parenting Stress Index to measure parent-child problem areas; and a form with 
questions about parent’s impression of child change. (see Appendix 2) 
 
Intervention Procedures 
Children will be randomly assigned to one of two parent interventions— an information, 
education and support (Group), or Group plus parent-implemented intervention (Individual). A 
treatment manual with detailed procedures and fidelity measures are provided in the Appendix. 
Following is a brief description of each condition. 
Group Procedures. Group is organized for families to receive information about social 
communication, emotional regulation, play development, and behavioral challenges in toddler 
playgroups in a relaxed, supportive, child-friendly setting that provides the opportunity to talk 
with a professional and meet other parents. Group is designed to provide parents with 
resources and supports for their child through weekly small parent group meetings using a 
curriculum to help parents focus their attention on their child’s developmental needs. Handouts 
with activities for the parents and children to participate in during the month will be provided 
and samples are included in the Appendix. Group is different than Individual because it does not 
provide individualized intervention, does not provide direct instruction to the parent in the 
home on how to implement strategies and supports, and does not ensure treatment fidelity or 
the level of intensity. Up to 12 families will attend each group, with a blend of children with 
early risk for ASD ranging in age from 12 to 24 months. The groups are guided by an 
interventionist from psychology or a related discipline and meet for 9 months during the 
intervention period and monthly follow-up sessions with parents through the child’s 36 month 
birthday. Information is provided to families through discussion and handouts, answering 
questions, describing scenarios, and making suggestions. Little documentation on generalization 
of group education training for parents is available. Kaiser and colleagues concluded that while 
there was variability in the speed and consistency of learning that occurred by parents, it took 
an average of 20 individualized clinical sessions prior to generalized use of the procedures in the 
home setting. In a large-scale review of empirical studies of parent implemented interventions 
for young children with communication disorders, including ASD, Hancock and Kaiser identify 
generalization of the intervention strategies by parents into the home environment as key. 
Thus, we have designed Group to provide helpful information and support to families; however, 
we do not anticipate that families will generalize the use of intervention strategies to activities 

at home from the education meeting. 
 
The playgroup will consist of children enrolled in this study as well as community volunteers. 
Community volunteer children will be typically developing. We will not collect any data on the 
volunteers and their parents/caregivers will be advised of the time commitment if they would 
like to participate. If a research staff member deems it appropriate, the community volunteer 
may be referred for services outside of the study.  
 
Individual Procedures. Individual teaches parents how to support their child’s communication, 
social, and play skills in everyday routines, activities, and places. The clinician meets with 
parents for 2 home visits per week for 9 months. Individual is organized by phases, beginning 
with the initial home visit, a month of program planning, 6 months of intervention 
implementation, and 2 months of generalization. The initial home visit is designed to provide an 
overview of Individual to the family and to discuss the importance of intensive intervention, 
defined as active and productive engagement for 20-25 hours per week for children with ASD. 
The program planning phase entails completing the SCERTS Assessment Process (SAP), which is 
a curricular-based assessment using parent report and observation for children with ASD 60 to 
identify goals and objectives for the child and teaching strategies and supports for the parents. 
The program planning phase is completed by mapping out which objectives will be targeted in 
which routines and activities to total 5 hours a day, 5 days a week. Some assessment forms are 
included in the Appendix, others have been added to the IRB Smartform. The parent who is the 
primary caregiver will be the focus of Individual training. If both the mother and father or an 
extended family member share caregiving, then they can participate as long as they can attend 
Individual sessions regularly and are available for the home observation. In the implementation 
phase, the 2 weekly sessions will include the following three components: 1) setting the stage to 
briefly review and revise the agenda for that visit and gather updates; 2) intervention 
implementation with the following steps: a) review the objective, b) use modeling, guided 
practice, or video review to teach the strategy, c) provide feedback to the parent, and d) 
problem solving and plan for next time; steps a-d are repeated for 3 to 5 activities per session; 
and 3) summarize plans for parent implementation between sessions and data collection using 
ESI Daily Intervention Log. During generalization, the clinician meets with the family in a variety 
of community settings to teach the parent how to implement strategies in new settings. 
Measures/Handouts/Guides 
Parent Questionnaires Completed Monthly from 12-36 Months 
 
Baby Siblings Research Consortium Inventory History Form 
Parent Questionnaires Completed Monthly every 6 Months from 
12-36 Months 
 
ESI Home and Community Activities Family Impact 
Questionnaire 
 
Family Resource Scale 
 
Parenting Daily Hassles 
 
Parenting Sense of Competence  
 
Parenting Stress Index-Short Form 
Intervention Planning and Monitoring Forms (Individual) 
 
Routines-based Family Interview 
 
SCERTS Assessment Process (SAP)—SAP Report, SAP 
Observation, and SAP Summary Forms 

 
ESI Weekly Intervention Log 
 
Home Visit Notes 
 
Building Support from the Bottom Up: Promoting Your Child's 
Active Engagement 
 
Keeping an Eye on Weekly Progress: How's it going? Where do 
we go from here? 
  
Home Observation Feedback Form 
Fidelity of Delivery by Interventionist: Interventionist Fidelity Forms 
(Individual & Group) 
 
Interventionist Fidelity Form for Parent-Implemented 
Intervention (Individual) 
 
Interventionist Fidelity Form for Information, Education, & 
Support (IES) 
Fidelity of Receipt by Parent: Completed Weekly by Interventionist 
& Parent from 12-21 months (Individual) 
 
Reflection Questions on Weekly Progress 
 
Caregiver Involvement Scale 
 
Caregiver Diary 
Fidelity of Enactment: Parent Implementation of Intervention 
Strategies at Home (Individual& Group) 
 
About Transactional Supports 
 
Everyday Activities of Toddlers and Their Families: Making Every 
Moment Count 
 
Instructions for Home Observation from 12 to 36 months 
 
Measure of Active Engagement and Transactional Support 
(MAETS) 
 
Identifying Priority Intervention Outcomes 
Intervention Satisfaction Forms Completed by Parents (Individual & 
Group) 
 
ESI Family Evaluation Survey for Individual 
 
ESI Family Evaluation Survey for Group 
 
 
 
Fidelity and Program Evaluation Procedures 
Three components of intervention fidelity—delivery, receipt, and enactment and parent 
satisfaction will be measured and are included in the Appendix 2. Fidelity of delivery will be 
measured bi-weekly for Individual and bimonthly for Group to monitor whether the clinician 
delivered or implemented the intervention to the parent as intended from a video of an 
intervention session. The intervention coordinators from FSU will rate the clinicians using the 
Clinician Fidelity Review Form for Individual or Group and give feedback on any deviations from 
the intervention procedures on an ongoing basis.  Fidelity of receipt will be measured only 
during Individual by interventionist rating of the parent’s receipt of information that week and 
ability to implement the strategies and supports that they are learning using the Clinician Reflect 
Questions filled out weekly by the interventionist, the Caregiver Diary filled out weekly by the 
parent to monitor the parent comfort and buy-in to the treatment, and the Caregiver 
Involvement Scale filled out weekly by the interventionist to rate parent comfort and buy in to 
the treatment. These measures were developed by UCLA and are used in the AIR-B network and 

in the ESI ongoing RCT. The clinician will then make adjustments and give feedback to the parent 
on an ongoing basis. Fidelity of enactment will be measured for both Individual and Group from 
the monthly home observation using the MAETS to monitor whether the parent enacts the 
intervention strategies in natural situations when the clinician is not present. Parent 
Satisfaction in intervention will be measured using the Individual and Group Family Evaluation 
Survey. Each survey solicits information about the parent’s satisfaction with many aspects of the 
intervention as well as their sense of competence in supporting their child’s development. 
 
Expected Impact 
 
With the infrastructure available for the Emory ACE Center, in collaboration with the 
FSU Autism Institute, this new collaborative team will be able to implement a large-scale 
treatment study of one of the youngest samples of children with diagnostic features of ASD. The 
expected impact of this study will: 1) document improved outcomes for the youngest sample of 
children with ASD receiving a manualized, cost efficient, appropriate, and effective intervention 
that is implemented in community-based settings; and 2) substantiate that individualized 
intervention beginning by 12 months of age leads to better outcomes, providing evidence that 
early detection of autism is crucial to enable access to early intervention. 
 
 
6. 
Statistical Analysis 
Data Analyses and Power  
Data Analytic Strategy. The main research aims and hypotheses will be analyzed using a 
series of mixed models, focusing on Growth Curve Modeling (GCM) and Random-Effects 
Regression (RER) as more powerful alternatives to repeated measures ANOVA, and estimates of 
effect sizes will be obtained. We anticipate that effect size estimates will be conservatively 
derived from simple inspection of observed differences in treatment versus control means 
divided by the appropriate standardizer (either the control standard deviation or the pooled 
standard deviation, depending upon whether the treatment is inducing group differences in 
variances or not). The research aims compare growth trajectories (or residualized change, or 
outcome only, depending on the dependent variable of interest) for children in the treatment 
and control groups. It is hypothesized that children receiving the Group plus Individual condition 
will show significantly faster growth trajectories or change on the MAETS, which will mediate 
social communication, autism symptoms, developmental level, and adaptive behavior 
outcomes. Unconditional models that vary in complexity will be used to determine the most 
parsimonious models for estimating growth in this sample. After fitting the overall model, we 
will perform fixed-effects contrasts to test for cross-sectional differences between the two 
groups at points along the curve. Aims 2 and 3 build upon these models to investigate potential 
mediator and moderator variables that may predict response to treatment. Moderator variables 
such as initial level of child or parent performance and measures of family functioning will be 
interacted with treatment group to investigate potential moderating relationships. To 
investigate potential mediators of treatment effectiveness such as MAETS, we will follow 
standard strategy for testing mediational effects in a multilevel design where fidelity is 
conceptualized as a level 1 mediator that can vary by time. Finally, we will consider the 
possibility that the mediated relation may be stronger in one subgroup than the other 
(moderated mediation), either because treatment fidelity is accomplished to a greater extent in 
one subgroup than another or because the link between treatment fidelity and outcome is 

stronger in one subgroup than another (e.g., treatment fidelity predicts outcome only in 
individuals with sufficient cognitive abilities). In addition to existing GCM/RER analyses, in 
synergy with Projects I & II we will repeat our analyses using Functional Data Analysis, a new 
approach that significantly improves both the detection of common features in trajectory shape 
as well as the identification of individual spurts or delays relative to the group. Project III will rely 
on the Data Management and Analysis Core for data storage, management, and transmission to 
NDAR.  
Attrition Analyses. All analysis will be done using an intention to treat approach. That is, 
every subject in the study will be considered in the analysis as a member of the treatment group 
to which s/he was assigned. We will conduct a series of analyses to examine attrition and its 
potential effect on the results 69, including examining the differential attrition rates for the two 
treatments and for child and parent characteristics of those completing and those who did not 
complete one or both treatment conditions, different definitions of dropout, different outcome 
measures, and treatment-correlated attrition. For the HLM analyses with multiple time points, 
missing data are not a concern, but differential attrition by treatment group would be. If 
differential attrition appeared to be a problem, then we would conduct multiple imputation of 
missing data 95 to attempt to estimate the appropriate effect sizes and confidence intervals.  
Power Analyses. Power for growth curve modeling was estimated using a power estimation 
program developed for HLM models 61. When estimating power in growth curve models, there 
are a number of factors that need to be considered. In addition to alpha level, number of 
subjects, and anticipated effect size, power can also vary as a function of the number of 
observations employed and the duration of the study. For these power analyses, we set alpha at 
.05 and we anticipated as few as 5 and as many as 25 observations per child (per measure). 
Additionally, we estimated that there would be approximately 10 times as much within person 
variability than between person variability (the ICC for the person level effect would be .10). 
Using these estimates, we anticipate that 92 subjects would give us a power=.90 to detect an 
effect of d=.50 (which corresponds to a medium effect) with five time points estimating linear 
change. For models testing treatment differences in the presence of quadratic change (with 15 
or more assessments per child), power is .95. If attrition drops the sample size to 80 subjects, we 
will still have power equal to .86 to detect a medium-sized effect (with five assessments 
estimating linear change) and power=. 91 for those treatment differences tested in the presence 
of quadratic change. Thus, the minimum power to detect medium effects with 80 subjects is .86. 
We anticipate that the use of FDA and PACE will increase power. 
 
7. 
Risks 
Parents will be informed that at any time during their participation in this study, they will have 
the opportunity to refuse to participate in any procedures or withdraw from the study at any 
time without prejudice or effect on them and their child. The initial assessment portion of this 
study takes about 5 hours, there is a risk that a child may become bored or tired. To minimize 
fatigue, breaks will be taken whenever necessary. This amount of time is typical for an 
assessment with children. We will take breaks and can reschedule as necessary.  
Attempts will be made to stop an assessment and/or treatment if the child seems to be reacting 
negatively. If a child becomes unduly upset, the assessment and/or treatment will stop 
immediately and attempts made to comfort the child. A follow-up phone call to the parent will 
be made in order to determine that the child and parent are comfortable. Participants do not 
have to answer any questions that they are not comfortable with. They are free to ask questions 
at any time during the study. Steps taken to minimize the risk to confidentiality include: (1) 

keeping all data containing personal information in a locked file cabinet in a locked office to 
which only the research coordinators have access; (2) assigning identification numbers to all 
participants for tabulation of data; and (3) using identification numbers on all tests, 
questionnaires, and videotapes shared with other network sites. Participants will be informed 
that they do not have to answer any questions that may cause them discomfort. We will be as 
flexible as possible in scheduling assessments, and make expected time commitments clear to 
parents at the beginning of the study. Referrals for other treatment will be made if necessary. 
We have developed a specialized Microsoft Access database with tables linked by an assigned 
identification code to enter all of the data that will be gathered for this study. The database is 
housed on a web server with encrypting and password protection in compliance with HIPPA 
regulations. It is necessary for the project to have identifying information, including names and 
addresses, since clinical reports are generated from the project. Because the database is stored 
on a HIPPA compliant server that is accessed over the internet, if the actual project computers 
were stolen, the user could not access the database, thus protecting the security and 
confidentiality of the records. Queries are designed so that only de-identified data using the 
identification code will be exported and used for data analysis. Video recordings will be stored 
on a secure server in a password protected program. 
8. Adverse Event Reporting 
The procedures to be used in the study have no known hazards and are comparable with 
assessment and treatment procedures that have been used in psychological research for 
decades in infants, toddlers, and adults. During clinical and home visits, a parent will remain 
with the child at all times. If a child expresses displeasure due to any cause, the session will be 
suspended. With parental permission, treatment and/or assessment will continue when the 
parent deems that the child is ready. The researchers, clinicians, and research assistants who 
interact with the children and families have a background in child development and thorough 
knowledge of all experimental procedures.  
All information that is collected in connection with this study will remain confidential 
and will only be disclosed as required by U.S. or State law. Examples of information that we are 
legally required to disclose include abuse of a child or elderly person, or certain reportable 
diseases. Every foreseeable precaution to protect confidentiality will be taken. As in all research 
studies, the potential risk for a loss of confidentiality exists (i.e., computer viruses, computer 
hackers). However, every reasonable precautionary measure will be taken to protect 
confidentiality of all data. Computers will regularly be updated for virus protection. 
 
9. Data and Safety Monitoring Plan 
Although minimal risks are anticipated, a Data and Safety Monitoring Plan (DSMP) will 
be established and will be responsible for data and safety monitoring. The DSMP will include the 
PI, Project Coordinator, and the Family Resource Coordinator from each site and will be headed 
by the PI. The DSMP will include a monthly meeting. across-site DSMP members will meet every 
six months through teleconference for review of child and family progress and inspection of the 
reliability of assessment measures and treatment fidelity measures to ensure the validity and 
integrity of the data. If any adverse events are identified, an adverse event report will be 
provided to the IRB at Emory and FSU and the funding Institute and Center. If children show an 
extremely slow rate of progress or regression, parents will be encouraged to increase 

community resources that are available in the same way as they would be in our clinic. Other 
treatments will be considered as covariates of treatment effects. Although this may make 
interpreting the data more difficult, it would be unethical to deny children more intense 
treatment because of our research.  
 
This research project proposes to manage data using Emory Amazon Web Services 
(Emory AWS), which is an Emory customized implementation of the Amazon Web Services on-
demand cloud infrastructure for high-performance computing, data storage, database 
management, data sharing and hosting. Emory AWS provides investigators with access to many 
of the key research computing services offered by AWS. Additional security and technical 
controls help ensure that data are protected from unauthorized use, and that data storage and 
processing are conducted in a standardized, secure and HIPAA-eligible environment. 
 
 
When using Emory AWS from the Emory campus, traffic flows through the Emory core 
network to the AWS environment, ensuring secure data transmission. Account creation is 
limited to Emory-authorized users and accounts are password protected, ensuring secure data 
access. As part of the account creation process, Emory AWS provisions a set of virtual private 
cloud environments that are automatically set to an approved configuration limiting user 
privileges and access to data and services, with appropriate levels of security and minimal risk of 
variations. Data stored in AWS are automatically encrypted with automatic versioning, backup, 
and logging, ensuring data integrity. All AWS services enabled in Emory AWS have been assessed 
for potential risks by the Emory Information Security team. Where applicable, the teams have 
built out monitoring and remediation controls to check and ensure that accounts do not 
implement configurations that may have unintended consequences or move them to a state of 
non-compliance. 
 
 
For example, all storage must be encrypted; if storage is configured to be unencrypted, 
the monitor will notify the account owner and unmount the storage. All of these processes are 
automated, providing a greater level of assurance around data security, access control, firewall 
rules, network configurations, and environment setups. To satisfy HIPAA regulations, Emory has 
entered into a Business Associate Agreement (BAA) with Amazon Web Services. As a result of 
these precautions, Emory AWS may be used to store, manage, process and analyze data, 
including Emory electronic protected health information (ePHI), for the purpose of human 
subjects research. 
 
 
 

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