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Social Value Training in Toddlers With Elevated Autism Symptoms (SVT)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Value Learning Training
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

15 Months - 21 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Social Value Learning

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2018
Last Updated
July 14, 2022
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03556826
Brief Title
Social Value Training in Toddlers With Elevated Autism Symptoms
Acronym
SVT
Official Title
Feasibility and Preliminary Efficacy of Social Value Training in Toddlers With Elevated Autism Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Value Learning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Value Learning Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of looking at faces during the laboratory and real-world tests
Description
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
Time Frame
Average trial duration: for laboratory task: 2 seconds, for real-world task: 1 minute
Secondary Outcome Measure Information:
Title
Proportion of looking at the scene during laboratory and real-world tests
Description
The proportion of valid eye tracking time collected during test trials standardized over the test trials duration
Time Frame
Average trial duration: for laboratory task: 2 seconds, for real-world task: 1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
21 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Chawarska, PhD
Phone
203 499 8943
Email
katarzyna.chawarska@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Brennan-Wydra, MSI
Email
emma.brennan-wydra@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Chawarska, PhD
Organizational Affiliation
Social and Affective Neuroscience of Autism Program, Yale Child Study Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Chawarska, PhD
Phone
203-499-8943
Email
katarzyna.chawarska@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Social Value Training in Toddlers With Elevated Autism Symptoms

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