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NCT05604326 · ClinicalTrials.gov registry record · NA
Evaluating the Efficacy of Pathways Parent-Mediated Early Autism Intervention on Social Attention and Language
A NA study, sponsored by The University of Texas at Dallas.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT05604326: Completed NA study, sponsored by The University of Texas at Dallas.
NCT05604326 is a NA study that has completed, run by The University of Texas at Dallas. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05604326, a NA study, has completed, sponsored by The University of Texas at Dallas.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism. Question 1: Is Pathways more effective than a PEI at (a) fostering the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism and (b) relieving their parents' stress? Question 2: Is the magnitude of the relationship between early and later developing attention greater in children whose parents receive Pathways compared to children whose parents receive PEI? Question 3: Is the magnitude of the relationship between joint attention and social communication and language greater in children whose parents receive Pathways compared to children whose parents receive PEI? Participants will be randomized into 24 weeks of Pathways or PEI. Participants will receive a battery of assessments to evaluate the child's cognitive, social attention, social communication, language, and adaptive functioning, and parental stress at four different time points spaced every 12 weeks from baseline to three-month follow-up.
Primary Outcome
Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of social orienting (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured.
Interventions
- BEHAVIORAL Pathways Intervention
- BEHAVIORAL Parent Education Intervention (PEI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2022-10-27 |
| Est. Completion | 2025-02-01 |
| Phase | NA |
What the finished NCT05604326 record still lists
NCT05604326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Pathways Intervention is the first listed.
NCT05604326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05604326 about?
NCT05604326 is a clinical study titled "Evaluating the Efficacy of Pathways Parent-Mediated Early Autism Intervention on Social Attention and Language". The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism. ...
What is the current status of trial NCT05604326?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2022-10-27. Estimated completion is 2025-02-01.
What interventions are being tested in trial NCT05604326?
The interventions under investigation include: Pathways Intervention (BEHAVIORAL), Parent Education Intervention (PEI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05604326?
This trial is sponsored by The University of Texas at Dallas, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05604326's enrollment target sits among peer trials
58 1256th of 2000 higher than 740 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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