Biomarkers of Developmental Trajectories and Treatment in Autism Spectrum Disorder (ASD)
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | Any |
Updated: | 10/12/2018 |
Start Date: | January 2013 |
End Date: | September 2018 |
Joint Engagement in Infants at Risk for ASD: Integrating Treatment With Biomarkers
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.
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.
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.
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
We found this trial at
1
site
Los Angeles, California 90024
Principal Investigator: Connie Kasari, PhD
Phone: 310-206-1268
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