- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307057
Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families
Study Overview
Status
Conditions
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. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nathan Call, PhD
- Phone Number: 404-785-9428
- Email: ncall@emory.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30329
- Marcus Autism Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social Communication Growth Charts (SCGC)
Infants with a sibling who is diagnosed with ASD, who are randomized to receive the Social Communication Growth Charts (SCGC) intervention.
|
The Social Communication Growth Charts (SCGC) is a web-based tool that parents can access to teach them the social communication milestones that are developing from 6 to 24 months of age.
The SCGC has an explore function with hundreds of video clips illustrating 80 social communication milestones and a support video that has narration explaining how the parent in the video is supporting the child's development.
The SCGC also has a charting function that parents can use by answering questions about their child's social communication milestones and then view charts in 5 developmental domains.
Parents in the SCGC condition are also invited to a bi-weekly online Guided Tour to join other parents in a group meeting, like a book club, as they go through the SCGC.
|
No Intervention: Usual care
Infants with a sibling who is diagnosed with ASD, who are randomized to receive usual care.
|
|
Experimental: Parent-Implemented (P-I) Condition
Participants showing early signs of ASD at 12 months of age, randomized to receive a parent-implemented (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) based on the Early Social Interaction model.
|
The Parent-Implemented (P-I) condition is based on the Early Social Interaction (ESI) model, which is an evidence-based parent-implemented intervention involving active and productive engagement for 5 hours per day, 5 days per week for toddlers with ASD. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. Weekly home sessions with a family navigator include:
Families can also access the Autism Navigator How-To Guide for Families (a self-guided, web-based course), the Online Guided Tour for the How-To Guide (an online group to engage families), and have the opportunity to interact with other families who suspect their child has autism through audio or video conferencing or typed chat. |
Experimental: Clinician-Implemented (C-I) Condition
Participants showing early signs of ASD at 12 months of age, randomized to receive a clinician-implemented (C-I) condition NDBI based on a hybrid model.
|
The Clinician-Implemented (C-I) condition is based on the core principles of empirically-supported naturalistic developmental behavioral interventions (NDBI) for infants and toddlers with or at-risk for ASD, including Early Start Denver Model (ESDM), Project ImPACT (Improving Parents As Communication Teachers), Pivotal Response Treatment (PRT), and Early Social Interaction (ESI).
The goal of C-I NDBI is to use naturalistic, developmental, and behavioral strategies with infants at-risk for ASD to improve social-communication, which includes eye contact, gesture use, intentional vocalizations, and language.
Parents are not actively involved in C-I NDBI intervention sessions, though they may observe and the clinician will be given information about current social-communication targets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Measure of Active Engagement and Transactional Supports (MAETS) Score
Time Frame: 9, 12, 16, 21, and 30 months of age
|
Parent contingent responsiveness will be assessed using the Transactional Support section of the Measure of Active Engagement and Transactional Supports (MAETS). This assessment will occur during home observation of everyday activities. This section includes 8 components: promoting participation and a productive role, providing structure to make activities predictable, using language that follows the child's focus of attention, promoting child initiations, providing a balance of communicative turns, supporting the development of child comprehension, providing verbal and nonverbal models, caregiver creates appropriate expectations and demands. Each component is scored on a 4 point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, 3 = Mastery. Total scores range from 0 to 32 and lower scores indicate that the level of support is low. Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC). |
9, 12, 16, 21, and 30 months of age
|
Change in Communication and Symbolic Behavior Scales (CSBS) Score
Time Frame: 9, 12, 16, 21, and 30 months of age
|
Change in social communication skills will be measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later converted scores. The raw scores will be summed to form a social, speech, and symbolic composite. The social composite includes emotion and eye gaze, communication and gestures, and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all three composites range from 0 to 171. Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC). |
9, 12, 16, 21, and 30 months of age
|
Change in Autism Diagnostic Observation Schedule Score
Time Frame: 9, 12, 16, 21, and 30 months of age
|
Autism symptoms will be measured with the Autism Diagnostic Observation Schedule, Second Edition is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms will be used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism. Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC). |
9, 12, 16, 21, and 30 months of age
|
Change in Mullen Scales of Early Learning Score
Time Frame: 9, 12, 16, 21, and 30 months of age
|
This study will use four scales of the Mullen Scales of Early Learning (MSEL) to measure developmental level. with separate scores for four cognitive scales that form an early learning composite. A nonverbal developmental quotient (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. A verbal DQ will be calculated from the Expressive Language and Receptive Language scales. Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC). |
9, 12, 16, 21, and 30 months of age
|
Change in Vineland-3 Adaptive Behavior Scales Score
Time Frame: 9, 12, 16, 21, and 30 months of age
|
Adaptive Behavior will be measured with the Vineland-3 Adaptive Behavior Scales. The Vineland-3 provides a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills, which yield an Adaptive Behavior Composite score. The normative mean score of the Adaptive Behavior Composite is 100 with a normative standard deviation of 15. Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC). |
9, 12, 16, 21, and 30 months of age
|
Change in Measure of Active Engagement and Transactional Supports (MAETS) in Parents of Children Showing Signs of ASD
Time Frame: 12 months of age to 21 months of age
|
Parent contingent responsiveness will be assessed during home observation of everyday activities.
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.
|
12 months of age to 21 months of age
|
Change in Communication and Symbolic Behavior Scales (CSBS) Score in Children Showing Signs of ASD
Time Frame: 12 months of age to 21 months of age
|
Change in social communication skills will be measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later converted scores. The raw scores will be summed to form a social, speech, and symbolic composite. The social composite includes emotion and eye gaze, communication and gestures, and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all three composites range from 0 to 171. Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention. |
12 months of age to 21 months of age
|
Change in Autism Diagnostic Observation Schedule Score in Children Showing Signs of ASD
Time Frame: 12 months of age to 21 months of age
|
Autism symptoms will be measured with the Autism Diagnostic Observation Schedule, Second Edition is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms will be used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism. Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention. |
12 months of age to 21 months of age
|
Change in Mullen Scales of Early Learning Score in Children Showing Signs of ASD
Time Frame: 12 months of age to 21 months of age
|
This study will use four scales of the Mullen Scales of Early Learning (MSEL) to measure developmental level. with separate scores for four cognitive scales that form an early learning composite. A nonverbal developmental quotient (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. A verbal DQ will be calculated from the Expressive Language and Receptive Language scales. Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention. |
12 months of age to 21 months of age
|
Change in Vineland-3 Adaptive Behavior Scales Score in Children Showing Signs of ASD
Time Frame: 12 months of age to 21 months of age
|
Adaptive Behavior will be measured with the Vineland-3 Adaptive Behavior Scales. The Vineland-3 provides a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills, which yield an Adaptive Behavior Composite score. The normative mean score of the Adaptive Behavior Composite is 100 with a normative standard deviation of 15. Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention. |
12 months of age to 21 months of age
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nathan Call, PhD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00098127
- P50MH100029 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheActive, not recruitingAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan
Clinical Trials on Social Communication Growth Charts (SCGC)
-
Hugo W. Moser Research Institute at Kennedy Krieger...HRSA/Maternal and Child Health BureauCompleted
-
Northwestern UniversityUniversity of Texas at AustinRecruiting
-
Université Catholique de LouvainTerminatedAutism Spectrum Disorder | Developmental Language DisorderBelgium
-
Chinese University of Hong KongRecruitingAutism Spectrum Disorder | Parenting | Autism | Speech Therapy | Social CommunicationChina, Hong Kong
-
University Hospital, ToursCompleted
-
The University of Texas Health Science Center,...The Institute for Rehabilitaion and Research FoundationCompleted
-
Swiss Tropical & Public Health InstituteBoston University; Innovations for Poverty ActionCompleted
-
Centre for Injury Prevention and Research BangladeshNot yet recruitingEarly Childhood Developmental Disability (Disorder)
-
University of California, Los AngelesCompletedDiabetes | Cervical Cancer Screening | Primary Health Care | Behavioral Economics | Colorectal Cancer Screening | Health Maintenance | Chlamydia Screening | HPV ScreeningUnited States
-
Boston University Charles River CampusNational Cancer Institute (NCI)CompletedChildhood Cancer | Posttraumatic Stress Disorder | Pediatric Cancer | SiblingsUnited States