Biomarkers of Developmental Trajectories and Treatment in Autism Spectrum Disorder (ASD)

Not Applicable

Completed

• Conditions: Children at Risk for ASD
• Interventions: Behavioral: Standard Baby Classroom; Behavioral: Baby JASPER

• Registration Number: NCT01874327
• Lead Sponsor: University of California, Los Angeles

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-28
• Study Start: 2013-01
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-11
• Primary Completion: 2018-08
• Study Completion: 2018-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Have elevated scores on the ADOS-Toddler version and clinical concern from professional (Pediatrician, Psychologist, etc). Because of the young age of children, we expect to intervene with children who do not yet have a diagnosis of ASD but may only show some risk by virtue of elevated scores on the ADOS-T.
• Have a parent available for parent-mediated sessions 2 times per week in the classroom
• Do not have seizures
• Do not have associated sensory or physical disorders
• Are not co-morbid with other syndromes or diseases

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Exclusion Criteria

• Other co-morbid syndromes or diseases
• Seizure activity
• Other sensory or physical disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Baby Classroom	Standard Baby Classroom	This classroom will focus more heavily on developing motor and cognitive skills
Baby JASPER	Baby JASPER	This classroom will spend the majority of the time focusing on social-communication goals

Primary Outcome Measures

Name	Time	Method
Assessing change in Parent Child Interaction (PCX) throughout the diverse time points.	Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit)	10 minute unstructured free play assessment with caregiver and child measuring change over the duration of the study.

Secondary Outcome Measures

Name	Time	Method
Early Social Communication Scales (ESCS)	Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit)
Autism Diagnostic Observation Schedule Toddler module (ADOS-T)	Prior to treatment commencing (Study Entry) and 10 months post treatment exit	Semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials
Imitation Task	Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit)
EEG/Event Related Potential (ERP)	Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit)
Mullen Scales of Early Learning (MSEL)	Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit)
Vineland Adaptive Behavior Scales (VABS)	Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit)
Structured Play Assessment (SPA)	Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit)

Trial Locations

Locations (1)

UCLA Semel Institue; 🇺🇸 Los Angeles, California, United States