Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families

Most children with autism spectrum disorders (ASD) require special education at school age at
staggering expenses to the educational system. The average annual cost for educating a child
with ASD, based on the US Government Accountability Office, is $18,790, compared to $12,500
for the average special education student, and $6,556 for a regular education student. With
effective early intervention (EI) services, the future is more promising. Through prior
research, it is known that providing intervention early has a greater impact; between 60 and
90% of children in intensive early treatment programs beginning by age 3 can learn to talk
compared to 50% without early treatment, and about half can make it into regular
kindergarten, compared to 10% without early treatment. While there is a national priority for
early intervention as evident in the mandate of Part C of the Individuals with Disabilities
Education Act (IDEA), there is a need for research on effective and feasible early
intervention programs for infants and toddlers with ASD.

The recommendations of the American Academy of Pediatrics to screen all children for ASD at
18-24 months of age makes the need for evidence-based interventions for toddlers with ASD
even more pressing. Advances in research have documented that ASD can be diagnosed reliably
by trained professionals at 18-24 months of age. And yet, the median age of diagnosis in the
US is 4-5 years. Lower income, minority, and rural families receive a diagnosis up to a year
and a half later, well beyond the opportunity for EI. Because the usual age of diagnosis of
ASD is between 3 and 6 years of age, there is limited research on early intervention for
infants and toddlers with ASD. Disparities in the age of detection of ASD delay the age of
entry into intervention for children from underserved families. Compounding this problem,
underserved families are underrepresented in intervention research, making them a critically
important population to target in future research. It is vitally important to develop and
document the effectiveness of interventions that could be implemented by public IDEA Part C
service delivery program in community-base settings and that are feasible for low income and
other underserved families.

The overarching goal of this treatment project is to document the efficacy of very early
transactional supports that parents can learn to change developmental trajectories and
optimize outcomes of their child using a 2-stage sequential multiple assignment randomized
trial (SMART) design to develop an adaptive intervention. All parent-infant dyads in the
Emory Autism Center of Excellence (ACE) will be invited at 6 months of age from the pool of
250 high and low risk siblings and will be randomly assigned at Stage 1 of this clinical
trial. In Stage 1, parents of participating children are randomized to a group utilizing the
Social Communication Growth Charts (SCGC), which use an innovative web-based technology to
teach parents early social communication milestones and how to support their child's very
early development, or Usual Care. This first stage of the study will compare efficacy of the
SCGC on parent contingent responsiveness and child developmental trajectories.

Families of children who show early signs of ASD at 12 months of age will be re-randomized to
Stage 2. The goal of Stage 2 of the study is to compare the efficacy of a parent-implemented
(P-I) condition of a naturalistic developmental behavioral intervention (NDBI) based on the
Early Social Interaction model, to a clinician-implemented (C-I) condition NDBI based on a
hybrid model. Children will receive the Stage 2 intervention from 12 to 21 months of age.

Outcome measures of social communication, autism symptoms, social visual engagement,
developmental level, and adaptive behavior will be gathered every 6 months from 6 to 30
months of age to measure treatment effects. Measures of parent transactional support and
child active engagement will be collected quarterly from 9 to 30 months of age to examine
growth trajectories during the Stage 1 and 2 conditions and at follow-up at 21 and 30 months
after intervention. The expected impact of this study will have the following important
implications: 1) maximize the use of technology to teach all parents how to support their
infant's development early to optimize opportunities for learning and recognize as early as
possible if their child is not meeting developmental milestones and may need intervention; 2)
document improved outcomes for very young children with early signs of ASD receiving a
manualized, evidence-based NDBI intervention that is cost-efficient and feasible for
community-based implementation; and 3) substantiate that these adaptive interventions
implemented by parents beginning at 6 months of age lead to better child outcomes, providing
evidence that very early detection of autism is crucial to improve developmental outcomes.

Inclusion Criteria for Stage 1:

- Have an ASD sibling who is in the Emory Autism Center of Excellence.

Inclusion Criteria for Stage 2:

- Nonresponse to Stage 1 intervention; a "nonresponder" is defined as infants who show
early signs of autism and communication delay.

- Shows early signs of ASD, defined by a positive score on the Infant-Toddler Checklist
(ITC) and at least two of the following autism screening tools: Early Screening for
Autism and Communication Disorders (ESAC), Systematic Observation of Red Flags of ASD
(SORF) Clinic, or SORF-Home.

Exclusion Criteria:

- Parent/caregiver declines to participate.