Social Value Training in Toddlers With Elevated Autism Symptoms (SVT)
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ClinicalTrials.gov Identifier: NCT03556826 |
Recruitment Status :
Recruiting
First Posted : June 14, 2018
Last Update Posted : June 18, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autism Spectrum Disorder | Behavioral: Social Value Learning Training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Feasibility and Preliminary Efficacy of Social Value Training in Toddlers With Elevated Autism Symptoms |
Actual Study Start Date : | December 13, 2019 |
Estimated Primary Completion Date : | August 31, 2023 |
Estimated Study Completion Date : | August 31, 2024 |

Arm | Intervention/treatment |
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Experimental: Social Value Learning
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.
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Behavioral: Social Value Learning Training
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. |
- 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
- 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 ]The proportion of valid eye tracking time collected during test trials standardized over the test trials duration

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Ages Eligible for Study: | 15 Months to 21 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556826
Contact: Katarzyna Chawarska, PhD | 203 499 8943 | katarzyna.chawarska@yale.edu | |
Contact: Emma Brennan-Wydra, MSI | emma.brennan-wydra@yale.edu |
United States, Connecticut | |
Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06511 | |
Contact: Katarzyna Chawarska, PhD 203-499-8943 katarzyna.chawarska@yale.edu |
Principal Investigator: | Katarzyna Chawarska, PhD | Social and Affective Neuroscience of Autism Program, Yale Child Study Center |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT03556826 |
Other Study ID Numbers: |
2000021541 P50MH115716 ( U.S. NIH Grant/Contract ) |
First Posted: | June 14, 2018 Key Record Dates |
Last Update Posted: | June 18, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |