Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT01874327
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2012-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Developmental Trajectories and Treatment in Autism Spectrum Disorder (ASD)
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
Joint Engagement in Infants at Risk for ASD: Integrating Treatment With Biomarkers
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BabyJ
Brief Summary:
The study will evaluate the efficacy of a novel intervention implemented in a classroom setting aimed at improving joint attention and joint engagement skills with infants who are at risk of developing an Autism Spectrum Disorder.
Detailed Description:
The proposed intervention adapts a parent-mediated intervention that successfully improved outcomes in toddlers with autism. The intervention model (a) targets the foundations of social-communication (joint attention, imitation, play), (b) uses naturalistic strategies to increase the rate and complexity of social-communication and (c) includes parents as implementers of the intervention to promote generalization across settings and activities and to ensure maintenance over time.
In addition to testing the primary effects of this early intervention on the developmental outcomes of children with signs of autism, we will examine whether this method is superior to an early intervention focused on global infant development. Because brain development occurs rapidly in infants and toddlers, we will use high density EEG to investigate (1) biomarkers of change in these infants as a result of intervention and (2) biomarkers predicting response to treatment, with focus on the neural correlates of social attention and learning from joint engagement.
Study Aims:
AIM 1: To examine the effects of the experimental intervention (Baby JASPER) on primary (joint attention) and secondary outcomes (receptive language, play, symbol-infused joint engagement and parent use of social communication support strategies).
AIM 2: To examine maintenance and generalization of the effects of the experimental intervention on children and their parents.
AIM 3: To examine electrophysiological biomarkers of change with treatment as well as predictors of social communication outcomes in children after intervention.
AIM 4 (exploratory): To examine the effect of potential child level and parent level moderators on the primary and secondary outcomes of the study across the two conditions.
In addition to testing the primary effects of this early intervention on the developmental outcomes of children with signs of autism, we will examine whether this method is superior to an early intervention focused on global infant development. Because brain development occurs rapidly in infants and toddlers, we will use high density EEG to investigate (1) biomarkers of change in these infants as a result of intervention and (2) biomarkers predicting response to treatment, with focus on the neural correlates of social attention and learning from joint engagement.
Study Aims:
AIM 1: To examine the effects of the experimental intervention (Baby JASPER) on primary (joint attention) and secondary outcomes (receptive language, play, symbol-infused joint engagement and parent use of social communication support strategies).
AIM 2: To examine maintenance and generalization of the effects of the experimental intervention on children and their parents.
AIM 3: To examine electrophysiological biomarkers of change with treatment as well as predictors of social communication outcomes in children after intervention.
AIM 4 (exploratory): To examine the effect of potential child level and parent level moderators on the primary and secondary outcomes of the study across the two conditions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: