Clinical trial NCT03785327: 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
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorder
Typical Development
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 78
Sex: MALE
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Subjective Social Interaction Quality
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: The University of Texas at Dallas
state: Texas
Study officials:
References: