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

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.

Study Overview

• Status: Terminated
• Conditions: Autism Spectrum Disorder; Typical Development
• Intervention / Treatment: Device: tDCS; Behavioral: Autism Training

Detailed Description

Intellectually-capable older adolescents and young adults with autism spectrum disorder (ASD) often struggle to secure and maintain employment, succeed in college, or develop satisfying personal and professional relationships. Current psychosocial interventions for this population have produced limited effects on real-world functioning. These programs typically seek to improve social skill and understanding with the hope that these abilities will translate to better functioning and are often effective at increasing knowledge of social rules and norms,yet these improvements frequently do not translate to better social and life outcomes in the real world. One reason for their limited efficacy may be that the mechanisms involved in real-life social interaction continue to be poorly understood for this population. The current study is designed to specify the factors that predict more or less favorable social outcomes for autistic adolescents and young adults when interacting with an unfamiliar, non-autistic peer, and test a multifaceted intervention for improving these outcomes. The intervention will target both brain and behavior, not only in the individual with ASD but also in their typically-developing (TD) partners. For TD participants, the efficacy of a training program will be tested to determine if social experiences for older adolescents with ASD can be improved by increasing knowledge, acceptance, and understanding of autism among TD individuals. For the participants with ASD, this study will test the efficacy of an innovative, non-invasive neurostimulation session using Transcranial Direct Current Stimulation (tDCS) to target social brain regions involved in perspective-taking and social reciprocity. Social outcomes for each intervention will be compared to a "no intervention" control condition, and to each other, to provide a comprehensive examination of intrinsic and extrinsic factors contributing to social interaction quality for autistic adolescents and young adults.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75080-3021
      • The University of Texas at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 21 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active anodal tDCS; Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS	Device: tDCS; Participants either complete active and sham tDCS sessions one week apart or an autism training program.
Sham Comparator: Sham tDCS; Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS	Device: tDCS; Participants either complete active and sham tDCS sessions one week apart or an autism training program.
Experimental: Autism Training Program; Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program	Behavioral: Autism Training; Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University
No Intervention: Social interaction without intervention; Control condition: Behavioral testing without an intervention component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Cognition	Social Cognition is assessed using a battery of social cognitive tasks assessing social perception, emotion recognition, and mentalizing.	Completed 5 minutes after subjective interaction quality measures

Collaborators and Investigators

• Sponsor: The University of Texas at Dallas

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 1806799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes