Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03556826 |
| Other study ID # |
2000021541 |
| Secondary ID |
P50MH1157161R01M |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2019 |
| Est. completion date |
March 3, 2020 |
Study information
| Verified date |
December 2023 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In the proposed pilot study, ASD+ toddlers will undergo Social Value Training (SVT) using a
gaze-contingent eye-tracking paradigm in toddlers with elevated symptoms of ASD (ASD+)
(n=48). SVT will be administered over a two-day period and the training effects will be
assessed by changes in visual attention to high-value (HV) faces as compared to low-value
(LV) faces between baseline, post-baseline, and a follow-up assessment using two tasks: a
laboratory selective attention (LSA) task and real-world selective attention (RWSA) task. The
investigators will also evaluate acceptability and feasibility of the value training and
contribution of sex, nonverbal developmental level, and severity of autism symptoms to
response to the training.
Description:
One of the markers of autism spectrum disorders (ASD) in infants and toddlers is impaired
selective attention to faces. This impairment diminishes their ability to learn from and
interact adaptively with others in real-world environments. Attentional selection in the
social domain relies, in part, on one's ability to encode reward values of people and store
these values in long-term memory as stable values. The 'stable' values (henceforth, 'values')
are learned over the course of repeated learning opportunities, and once acquired, they are
signaled rapidly, preferentially directing gaze to encoded faces of importance (high-value,
HV) based on their hedonic or informative properties in the past. Automatic responses based
on values stored in long-term memory are essential for survival when decisions have to be
made rapidly (e.g., mother versus stranger). Learning about values is subserved by the reward
learning system in the brain involving basal ganglia (BG) circuitry. This circuitry is
implicated in the pathophysiology of ASD and extant evidence suggests that individuals with
ASD exhibit specific impairments in learning the reward value of social stimuli such as
faces. Based on this evidence, the investigators propose that limited attention to faces in
toddlers with elevated autism symptoms (ASD+) is, in part, driven by impaired value learning
in the social domain, affecting their ability to rapidly and preferentially select HV faces
and ignore low-value (LV) faces in the complex real-world environment. Consequently, they
exhibit diminished spontaneous attention to faces in general, and when they look at faces,
they may distribute their limited attentional resources between high- (e.g., mother or
therapist) and low-value (stranger) individuals in a trial-and-error fashion. The
investigators further hypothesize that reinforcing attention of children with ASD+ toward
specific faces through social value training (SVT) will increase their attention to these
faces in real-world environments. In the proposed pilot study, ASD+ toddlers will undergo
Social Value Training (SVT) using a gaze-contingent eye-tracking paradigm in toddlers with
elevated symptoms of ASD (ASD+) (n=48). SVT will be administered over a two-day period and
the training effects will be assessed by changes in visual attention to high-value (HV) faces
as compared to low-value (LV) faces between baseline, post-baseline, and a follow-up
assessment using two tasks: a laboratory selective attention (LSA) task and real-world
selective attention (RWSA) task. The investigators will also evaluate acceptability and
feasibility of the value training and contribution of sex, nonverbal developmental level, and
severity of autism symptoms to response to the training.
Study was hindered by Covid and masking, therefore primary and secondary outcomes were unable
to be collected as intended.
