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

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ClinicalTrials.gov Identifier: NCT03307057
Recruitment Status : Suspended (The study activities are on hold due to COVID)
First Posted : October 11, 2017
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Nathan A. Call, Ph.D., BCBA-D, Emory University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Social Communication Growth Charts (SCGC) Behavioral: Parent-Implemented (P-I) Condition Behavioral: Clinician-Implemented (C-I) Condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: The diagnosticians for all measures will be kept blind to group assignment.
Primary Purpose: Treatment
Official Title: Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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.
Behavioral: Social Communication Growth Charts (SCGC)
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.
Behavioral: Parent-Implemented (P-I) Condition

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:

  1. developing the visit agenda
  2. intervention implementation including: guided/caregiver practice, feedback and problem solving
  3. planning for parent implementation between sessions

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.
Behavioral: Clinician-Implemented (C-I) Condition
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.




Primary Outcome Measures :
  1. Measure of Active Engagement and Transactional Supports (MAETS) [ Time Frame: 6 months of age to 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).


  2. Communication and Symbolic Behavior Scales (CSBS) Score [ Time Frame: 6 months of age to 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).


  3. Autism Diagnostic Observation Schedule Score [ Time Frame: 6 months of age to 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).


  4. Mullen Scales of Early Learning Score [ Time Frame: 6 months of age to 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).


  5. Vineland-3 Adaptive Behavior Scales Score [ Time Frame: 6 months of age to 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).


  6. 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.

  7. 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.


  8. 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.


  9. 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.


  10. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307057


Locations
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United States, Georgia
Marcus Autism Center
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Nathan Call, PhD Emory University
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Responsible Party: Nathan A. Call, Ph.D., BCBA-D, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03307057    
Other Study ID Numbers: IRB00098127
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nathan A. Call, Ph.D., BCBA-D, Emory University:
Pediatrics
Behavioral Research
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders