Completed

NCT Number: NCT01874327

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

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.

Completed

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Key information

Conditions

Children at Risk for ASD

Age range

12 month–21 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Semel Institue

Los Angeles, California, 90024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby JASPER

Behavioral

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

Standard Baby Classroom

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

Primary outcomes

Assessing change in Parent Child Interaction (PCX) throughout the diverse time points.

Time frame: 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 outcomes

Autism Diagnostic Observation Schedule Toddler module (ADOS-T)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)
Early Social Communication Scales (ESCS)

Time frame: 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)

Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Joint Engagement in Infants at Risk for ASD: Integrating Treatment With Biomarkers

Acronym: BabyJ

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Jun 11, 2013
Registry last updated: Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.