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Autism Spectrum DisorderSVTNCT03556826

Social Value Training in Toddlers With Elevated Autism Symptoms

A study testing Social Value Learning Training in people with Autism Spectrum Disorder, run by Yale University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 15 to 21 months
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Social Value Learning Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
13 Dec 2019to 3 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 21 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Singleton pregnancy
  • Gestational age of 37-42 weeks
  • Appropriate weight for gestational age
  • Presence of an older full biological sibling with ASD
  • Autism Diagnostic Observation Schedule-2 (ADOS-2) score at 18 months in the clinical range (calibrated severity score >3)

Who cannot join

  • Congenital infections
  • Non-febrile seizure disorder
  • Hearing loss
  • Visual impairment
  • Presence of any known chromosomal abnormality or congenital infection
  • Prenatal exposure to illicit drugs
  • Major psychotic disorder in first degree relatives.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale University School of Medicine

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: Feasibility and Preliminary Efficacy of Social Value Training in Toddlers With Elevated Autism Symptoms

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.

Read the detailed 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.

Being tested
Social Value Learning Training
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social Value Learning TrainingBehavioural

    For each child, two faces will be assigned the high-value (HV) status and the other two the low-value (LV) status. Value status will be randomized between the faces and children and all four faces will have the same probability of being assigned HV or LV across all participants. A gaze fixation on a HV face will always activate a dynamic display and the face will smile brightly. A gaze fixation on a LV face will always result in no change to its display.

Study groups in NCT03556826
Study groupRoleWhat they receive
Social Value LearningExperimentalFor each child, two faces, randomly selected from the pool of four faces, will be assigned the high-value (HV) status and the other two the low-value (LV) status. Value status will be randomized between the faces and children and all four faces will have the same probability of being assigned HV or LV across all participants. A gaze fixation on a HV face will always activate a dynamic display and the face will smile brightly. A gaze fixation on a LV face will always result in no change to its display. Effects of training will be tested one day (efficacy) and one month (maintenance) after training. During each of the follow-up assessments, each child will first undergo the Laboratory Selective Attention (LSA) task to assess if they retained value-face associations from the training sessions, followed by the Real-World Selective Attention (RWSA) task to evaluate generalization.
Receives: Behavioral: Social Value Learning Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of looking at faces during the laboratory and real-world tests

    The proportion of time spent attending to faces assigned HV and LV, standardized by the amount of valid eye-tracking data collected during the trial

    Measured: Average trial duration: for laboratory task: 2 seconds, for real-world task: 1 minute

Secondary outcomes (1)
  1. Proportion of looking at the scene during laboratory and real-world tests

    The proportion of valid eye tracking time collected during test trials standardized over the test trials duration

    Measured: Average trial duration: for laboratory task: 2 seconds, for real-world task: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2018
  2. Study start13 Dec 2019
  3. Primary completion3 Mar 2020
  4. Study completion3 Mar 2020

Why it stopped: Study was hindered by Covid and masking, therefore was unable to be completed as intended.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556826
Sponsor's protocol ID
2000021541
Other IDs
P50MH115716, 1R01MH124892-01A1
Acronym
SVT
Status last verified
Dec 2023
First submitted
1 Jun 2018
Last updated
19 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Social Value Learning Training in people with Autism Spectrum Disorder, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study was hindered by Covid and masking, therefore was unable to be completed as intended.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of looking at faces during the laboratory and real-world tests (time frame: Average trial duration: for laboratory task: 2 seconds, for real-world task: 1 minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.

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