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NCT03253081 · ClinicalTrials.gov registry record · NA
Heterogeneity in ASD: Biological Mechanisms, Trajectories, and Treatment Response
A NA study of Children With Autism, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT03253081 is a NA study of Children With Autism that has completed, run by University of California, Los Angeles. The registered enrollment target is 81 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03253081, a NA study of Children With Autism, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
Parent-mediated interventions often target social communication in young children with ASD, although to date studies yield inconsistent effects. One reason for the limited evidence may be the considerable heterogeneity in both parent and child characteristics that affect the fit of intervention to family and ultimately influence treatment outcome. For parents, these factors might include stress associated with the uncertainty of their child's diagnosis, caregiver expectations for the intervention itself, and a parent's own style of interaction that may be influenced by milder but qualitatively similar ASD characteristics, known as the broad autism phenotype (BAP). For children, these factors might include nonverbal DQ, language, or sensory impairment. The fit between type of intervention and optimal outcome for parent and child is an understudied, yet essential component of early intervention that may be susceptible to the influence of heterogeneity in the parent and child. One approach to addressing this variability is to implement an adaptive intervention approach that seeks to capitalize on heterogeneity among children and parents. Utilizing an adaptive treatment design, the current study tests the optimal sequence of intervention delivery and specific parent and child characteristics that may moderate treatment success in three 10-week stages of intervention. The first phase will randomize parents and children to a parent education condition, consisting of a parent support and education group focused on social communication development, or to a parent mediated and therapist delivered condition involving coaching of the parent with their child in social communication strategies. Phase 2 involves re-randomizing parents and children to maintain the same treatment arm, or change to the opposite arm to test the optimal sequence of intervention delivery and specific parent and child characteristics that may moderate treatment success. In the final phase, dyads are ran
Conditions Studied
Interventions
- BEHAVIORAL PARENT focused intervention
- BEHAVIORAL CHILD focused intervention
Study Locations (1)
California
- UCLA Semel Institute - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2024-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03253081
The ClinicalTrials.gov registry entry for NCT03253081 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Children With Autism appearing as the primary indexed condition, and to 2 interventions - of which PARENT focused intervention is the first listed.
NCT03253081 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03253081 about?
NCT03253081 is a clinical study titled "Heterogeneity in ASD: Biological Mechanisms, Trajectories, and Treatment Response". Parent-mediated interventions often target social communication in young children with ASD, although to date studies yield inconsistent effects. One reason for the limited evidence may be the considerable heterogeneity in both parent and child characteristics that affect the fit of intervention to f...
What is the current status of trial NCT03253081?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2018-06-15. Estimated completion is 2024-09-30.
What conditions does trial NCT03253081 study?
This clinical trial studies the following conditions: Children With Autism.
What interventions are being tested in trial NCT03253081?
The interventions under investigation include: PARENT focused intervention (BEHAVIORAL), CHILD focused intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03253081?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03253081 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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