Social Value Training in Toddlers With Elevated Autism Symptoms

NCT03556826 | Terminated

• 3 other identifiers: 2000021541P50MH1157161R01MH124892-01A1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (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

  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

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

Study Arms (1)

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.

Behavioral: Social Value Learning Training

Interventions

Social Value Learning Training 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.

Social Value Learning

Eligibility Criteria

• Age: 15 Months - 21 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Katarzyna Chawarska, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 14, 2018
• Study Start: December 13, 2019
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)