Social Value Training in Toddlers With Elevated Autism Symptoms

NCT ID: NCT03556826

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2020-03-03

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.

Study was hindered by Covid and masking, therefore primary and secondary outcomes were unable to be collected as intended.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Social Value Learning Training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Months
• Maximum Eligible Age: 21 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katarzyna Chawarska, PhD

Role: PRINCIPAL_INVESTIGATOR

Social and Affective Neuroscience of Autism Program, Yale Child Study Center

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

P50MH115716

Identifier Type: NIH

Identifier Source: secondary_id

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1R01MH124892-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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2000021541

Identifier Type: -

Identifier Source: org_study_id