Clinical trial NCT03307057: Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families
Official title: Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Pediatrics
Behavioral Research
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-10-11
Enrollment: 269
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study uses a 2-stage sequential multiple assignment randomized trial (SMART) design to develop an adaptive intervention. Participants will be randomized into one of two study arms at Stage 1 (6 months of age) and re-randomized into one of four arms for Stage 2 at 12 months of age. Certain study arms during Stage 2 will only be available for participants who are showing early signs of ASD.
Primary purpose: TREATMENT

Brief summary: This early treatment project is designed to address two significant public health challenges - the need for validated, manualized, treatments for young children with Autism Spectrum Disorder (ASD) that are cost-efficient and feasible for community-based implementation, and the need to reduce the age of entry into early intervention to optimize outcomes. This study will use a 2-stage sequential multiple assignment randomized trial (SMART) design to develop an adaptive intervention by comparing individual and combined effects of preventative parent education and autism treatment starting in infancy. All parent-infant dyads from the pool of 250 high and low risk siblings in the Emory Autism Center of Excellence (ACE) will be invited at 6 months of age and randomly assigned at Stage 1 to the Social Communication Growth Charts (SCGC) that use an innovative web-based technology to teach parents early social communication milestones and how to support their child's development very early or Usual Care (UC), in order to compare the efficacy on developmental trajectories from 9 to 30 months. Families of children who show early signs of ASD at 12 months of age based on tailoring variables using parent report and observational measures will be re-randomized at Stage 2 to compare efficacy of a parent-implemented (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) based on the Early Social Interaction (ESI)1 model to a clinician-implemented (C-I) condition of NDBI based on a hybrid model from 12 to 21 months of age. The investigators anticipate that 80 children will show early signs of ASD and that 56 families (70%) will agree to participate in the Stage 2 treatment. Growth trajectories of parent contingent responsiveness and child social communication will be collected longitudinally with repeated measures at 9, 12, 16, 21, and 30 months. Outcome measures of autism symptoms, developmental level, and adaptive behavior will be examined at 21 and 30 months to measure differential treatment effects.

Detailed description: 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 (UC). This first stage of the study will compare efficacy of the SCGC on parent contingent responsiveness and child developmental trajectories.

Participants will be re-randomized into one of four arms for Stage 2 when the children are 12 months of age. Families of children who do not show singes of ASD at 12 months of age will be re-randomized to SCGC or UC. Families of children who show early signs of ASD at 12 months of age will be re-randomized in Stage 2 to a parent-implemented (P-I) condition or a clinician-implemented (C-I) condition. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure of Active Engagement and Transactional Supports (MAETS) Score
timeFrame: 9, 12, 16, 21, and 30 months of age
measure: Communication and Symbolic Behavior Scales (CSBS) Score
timeFrame: 9, 12, 16, 21, and 30 months of age
measure: Autism Diagnostic Observation Schedule Score
timeFrame: 9, 12, 16, 21, and 30 months of age
measure: Mullen Scales of Early Learning Score
timeFrame: 9, 12, 16, 21, and 30 months of age
measure: Vineland-3 Adaptive Behavior Scales Score
timeFrame: 9, 12, 16, 21, and 30 months of age
measure: Measure of Active Engagement and Transactional Supports (MAETS) in Parents of Children Showing Signs of ASD
timeFrame: 12 months of age to 21 months of age
measure: Communication and Symbolic Behavior Scales (CSBS) Score in Children Showing Signs of ASD
timeFrame: 12 months of age to 21 months of age
measure: Autism Diagnostic Observation Schedule Score in Children Showing Signs of ASD
timeFrame: 12 months of age to 21 months of age
measure: Mullen Scales of Early Learning Score in Children Showing Signs of ASD
timeFrame: 12 months of age to 21 months of age
measure: Vineland-3 Adaptive Behavior Scales Score in Children Showing Signs of ASD
timeFrame: 12 months of age to 21 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: Nathan Call, PhD
role: PRINCIPAL_INVESTIGATOR
References: