Improving Social Interaction for Adolescents With Autism During the Transition to Adulthood

NCT03785327 | Terminated Results FDA Device

• 1 other identifier: 1806799
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the efficacy of two intervention strategies for improving social outcomes for autistic adolescents and young adults when interacting with unfamiliar non-autistic peers.

Conditions

Autism Spectrum Disorder; Typical Development

Outcome Measures

Primary Outcomes (1)

• Subjective Social Interaction Quality

  Non-autistic participants social interest in autistic partners as measured by the First Impression Scale (Sasson et al., 2017). Four items, each scored on a Likert Scale from 1 to 4 in which higher values indicate greater social interest, are averaged to produce a social interest composite that serves as the primary outcome measure of the non-autistic participant's social interest in their autistic conversation partner.

  Interaction with unfamiliar partner occurs immediately following the autism training; self-report measure given immediately after the interaction, duration of completion averages around 2 minutes

Study Arms (4)

Active anodal tDCS

EXPERIMENTAL

Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS

Device: tDCS

Sham tDCS

SHAM COMPARATOR

Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS

Device: tDCS

Autism Training Program

EXPERIMENTAL

Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program

Behavioral: Autism Training

Social interaction without intervention

NO INTERVENTION

Control condition: Behavioral testing without an intervention component

Interventions

tDCS DEVICE

Participants either complete active and sham tDCS sessions one week apart or an autism training program.

Active anodal tDCS; Sham tDCS

Autism Training BEHAVIORAL

Autism Information Presentation developed by Dr. Grace Iarocci's Autism \& Developmental Disorders Lab at Simon Fraser University

Autism Training Program

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-21
• DSM-IV-TR or DSM-5 diagnosis of an Autism Spectrum Disorder
• IQ\>70

You may not qualify if:

• Presence or history intellectual impairment (defined as IQ \<70)
• Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
• Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
• Not proficient in English
• Presence of substance abuse in the past one month
• Presence of substance dependence not in remission for the past six months
• Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

The University of Texas at Dallas

Richardson, Texas, 75080-3021, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Noah Sasson
• Organization: The University of Texas at Dallas

nsasson@utdallas.edu

972-883-2541

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Autistic participants were going to be recruited for an active or sham tDCS session. However, no participants were enrolled in these conditions due to COVID. TD participants were assigned to receive or not receive a training session.

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: December 24, 2018
• Study Start: January 18, 2019
• Primary Completion: July 31, 2021
• Study Completion: September 22, 2021
• Last Updated: December 23, 2022
• Results First Posted: December 23, 2022

Record last verified: 2022-12

Locations

US (1)