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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baby JASPER | Active Comparator | This classroom will spend the majority of the time focusing on social-communication goals |
|
| Standard Baby Classroom | Active Comparator | This classroom will focus more heavily on developing motor and cognitive skills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baby JASPER | Behavioral | Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Semel Institue | Los Angeles | California | 90024 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Abidin, R. R. (1983). Parenting Stress Index manual. Charlottesville, VA: Pediatric Psychology Press. | ||
| 15260871 | Background | Adamson LB, Bakeman R, Deckner DF. The development of symbol-infused joint engagement. Child Dev. 2004 Jul-Aug;75(4):1171-87. doi: 10.1111/j.1467-8624.2004.00732.x. | |
| 2010504 |
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| 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 |
|
| 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) |
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| 35678946 | Derived | Sterrett K, Magana MT, Gulsrud A, Paparella T, Kasari C. Predictors of Attrition in a Randomized Trial of a Social Communication Intervention for Infant-Toddlers at Risk for Autism. J Autism Dev Disord. 2023 Aug;53(8):3023-3033. doi: 10.1007/s10803-022-05616-w. Epub 2022 Jun 9. |