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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Social Value Learning | Experimental | For 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.
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)
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.
- First posted14 Jun 2018
- Study start13 Dec 2019
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Why it stopped: Study was hindered by Covid and masking, therefore was unable to be completed as intended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Katarzyna Chawarska, PhD, Principal investigator, Social and Affective Neuroscience of Autism Program, Yale Child Study Center
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of Social Value Training in Toddlers With Elevated Autism Symptoms
- ClinicalTrials.gov ID
- NCT03556826
- Acronym / sponsor ID
- SVT / 2000021541
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was hindered by Covid and masking, therefore was unable to be completed as intended.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Value Learning | Experimental | Behavioral: Social Value Learning TrainingFor 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. |
Who may qualify
- Ages
- 15 to 21 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- Congenital infections
- Non-febrile seizure disorder
- Hearing loss
- Visual impairment
- Presence of any known chromosomal abnormality or congenital infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Value Learning TrainingFor 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. | Behavioural | Social Value Learning |
Primary outcome
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
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
1 secondary outcome
Proportion of looking at the scene during laboratory and real-world tests
Time frame: Average trial duration: for laboratory task: 2 seconds, for real-world task: 1 minute
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Chawarska, PhD principal investigator
Social and Affective Neuroscience of Autism Program, Yale Child Study Center
1 site in 1 country: see every site and its status.
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.