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Trial record 39 of 257 for:    Recruiting, Not yet recruiting, Available Studies | "Autistic Disorder"

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

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ClinicalTrials.gov Identifier: NCT03556826
Recruitment Status : Not yet recruiting
First Posted : June 14, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Social Value Learning Training Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Months to 21 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Katarzyna Chawarska, PhD 203 499 8943 katarzyna.chawarska@yale.edu
Contact: Erin Barney, BS erin.barney@yale.edu

Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03556826     History of Changes
Other Study ID Numbers: 2000021541
P50MH115716 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders