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NCT01985022 · ClinicalTrials.gov registry record · NA
Changing Developmental Trajectories Through Early Treatment
A NA study, sponsored by Emory University.
- Terminated
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT01985022: Clinical Trial NA study, sponsored by Emory University.
NCT01985022 is a NA study that was terminated before completion, run by Emory University. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01985022, a NA study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
The major objective of this research protocol is to directly compare two parent intervention conditions of Early Social Interaction (ESI) for 9 months on developmental trajectories of infants showing early risk for Autism Spectrum Disorder (ASD). Participants will be randomized to receive an information, education and support group (Group) ESI intervention offered weekly, or a parent-implemented intervention (Individual) ESI intervention offered in twice-weekly, in combination with the Group ESI intervention.
Primary Outcome
Social communication skills were measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver were videotaped and later converted to scores. The standardized total score has a mean of 100 and standard deviation of 15. Scores below 100 indicate below average performance with the social, speech, and symbolic composites.
Interventions
- BEHAVIORAL Group-ESI
- BEHAVIORAL Individual-ESI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-05 |
| Est. Completion | 2019-11-26 |
| Phase | NA |
Why NCT01985022 stopped before completion
NCT01985022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Group-ESI is the first listed.
NCT01985022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01985022 about?
NCT01985022 is a clinical study titled "Changing Developmental Trajectories Through Early Treatment". The major objective of this research protocol is to directly compare two parent intervention conditions of Early Social Interaction (ESI) for 9 months on developmental trajectories of infants showing early risk for Autism Spectrum Disorder (ASD). Participants will be randomized to receive an informa...
What is the current status of trial NCT01985022?
This trial is currently terminated. It is a NA study. The enrollment target is 33 participants. The study started on 2013-05. Estimated completion is 2019-11-26.
What interventions are being tested in trial NCT01985022?
The interventions under investigation include: Group-ESI (BEHAVIORAL), Individual-ESI (BEHAVIORAL).
Who is sponsoring clinical trial NCT01985022?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01985022's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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