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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Children at Risk for ASD

Intervention / Treatment
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* Behavioral: Baby JASPER
* Behavioral: Standard Baby Classroom


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 21 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baby JASPER<br>This classroom will spend the majority of the time focusing on social-communication goals | Behavioral: Baby JASPER<br>* Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum<br>|
| Active Comparator: Standard Baby Classroom<br>This classroom will focus more heavily on developing motor and cognitive skills | Behavioral: Standard Baby Classroom<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing change in Parent Child Interaction (PCX) throughout the diverse time points. | 10 minute unstructured free play assessment with caregiver and child measuring change over the duration of the study. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism Diagnostic Observation Schedule Toddler module (ADOS-T) | Semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials | Prior to treatment commencing (Study Entry) and 10 months post treatment exit | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |