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

NCT ID: NCT01874327

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-09-30

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.

Conditions

Children at Risk for ASD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Baby JASPER

This classroom will spend the majority of the time focusing on social-communication goals

Group Type: ACTIVE_COMPARATOR

Baby JASPER

Intervention Type: BEHAVIORAL

Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum

Standard Baby Classroom

This classroom will focus more heavily on developing motor and cognitive skills

Group Type: ACTIVE_COMPARATOR

Standard Baby Classroom

Intervention Type: BEHAVIORAL

Assessment, Education and Programming System (AEPS) for Infants and Children curriculum focused on early developmental milestones in fine and gross motor, cognitive, adaptive and social areas

Interventions

Baby JASPER

Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum

Intervention Type: BEHAVIORAL

Standard Baby Classroom

Assessment, Education and Programming System (AEPS) for Infants and Children curriculum focused on early developmental milestones in fine and gross motor, cognitive, adaptive and social areas

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 21 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Connie Kasari, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCLA Semel Institue

Los Angeles, California, United States

Countries

United States

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Other Identifiers

12-000607

Identifier Type: -

Identifier Source: org_study_id