Improving Social Interaction for Adolescents With Autism During the Transition to Adulthood
Primary Purpose
Autism Spectrum Disorder, Typical Development
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Autism Training
Sponsored by
About this trial
This is an interventional basic science trial for Autism Spectrum Disorder
Eligibility Criteria
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)
Sites / Locations
- The University of Texas at Dallas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Experimental
No Intervention
Arm Label
Active anodal tDCS
Sham tDCS
Autism Training Program
Social interaction without intervention
Arm Description
Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS
Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS
Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program
Control condition: Behavioral testing without an intervention component
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03785327
First Posted
October 29, 2018
Last Updated
December 2, 2022
Sponsor
The University of Texas at Dallas
1. Study Identification
Unique Protocol Identification Number
NCT03785327
Brief Title
Improving Social Interaction for Adolescents With Autism During the Transition to Adulthood
Official Title
Improving Social Interaction for Adolescents With Autism During the Transition to Adulthood
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID disrupted data collection
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Dallas
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Typical Development
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active anodal tDCS
Arm Type
Experimental
Arm Description
Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS
Arm Title
Autism Training Program
Arm Type
Experimental
Arm Description
Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program
Arm Title
Social interaction without intervention
Arm Type
No Intervention
Arm Description
Control condition: Behavioral testing without an intervention component
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Participants either complete active and sham tDCS sessions one week apart or an autism training program.
Intervention Type
Behavioral
Intervention Name(s)
Autism Training
Intervention Description
Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University
Primary Outcome Measure Information:
Title
Subjective Social Interaction Quality
Description
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.
Time Frame
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
The University of Texas at Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080-3021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Improving Social Interaction for Adolescents With Autism During the Transition to Adulthood
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