Children at Risk for ASD
Conditions
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.
Interventions
BEHAVIORALBaby JASPER
Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum
BEHAVIORALStandard 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
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
12 Months to 21 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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 |
| 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) | — |
| 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) | — |
Countries
United States
Outcome results
None listed