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NCT03307057 · ClinicalTrials.gov registry record · NA
Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 269
- Enrollment target
NCT03307057 is a NA study that has completed, run by Emory University. The registered enrollment target is 269 participants.
The verdict
NCT03307057, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 269 participants
- Enrollment target
Study 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 mont
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Social Communication Growth Charts (SCGC)
- BEHAVIORAL Parent-Implemented (P-I) Condition
- BEHAVIORAL Clinician-Implemented (C-I) Condition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2024-10-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03307057
The ClinicalTrials.gov registry entry for NCT03307057 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Usual Care is the first listed.
NCT03307057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03307057 about?
NCT03307057 is a clinical study titled "Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families". 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...
What is the current status of trial NCT03307057?
This trial is currently completed. It is a NA study. The enrollment target is 269 participants. The study started on 2018-02-01. Estimated completion is 2024-10-08.
What interventions are being tested in trial NCT03307057?
The interventions under investigation include: Usual Care (BEHAVIORAL), Social Communication Growth Charts (SCGC) (BEHAVIORAL), Parent-Implemented (P-I) Condition (BEHAVIORAL), Clinician-Implemented (C-I) Condition (BEHAVIORAL).
Who is sponsoring clinical trial NCT03307057?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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