Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)
- Conditions
- AutismAutism Spectrum Disorder
- Interventions
- Behavioral: Cognitive Behavioral Therapy (CBT)Behavioral: Play Therapy
- Registration Number
- NCT01190917
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
The purpose of this study is to compare two different treatment approaches to social skills groups for high-functioning children with Autism Spectrum Disorder (ASD). This project will examine changes in both behavior and the brain following treatment.
- Detailed Description
Despite the fact that social skills impairments are the most persistent and pervasive symptoms affecting individuals with ASD, treatments targeting social skills have been the subject of few controlled investigations. The available literature suggests that cognitive behavioral techniques are commonly used and may improve targeted social skills in individuals with ASD. However, drawing firm conclusions about the efficacy of social skills treatment remains difficult, particularly with respect to maintenance of skills and generalization to natural settings, owing to methodological limitations of extant studies (e.g., small sample size, lack of manual-based curricula, minimal assessment of generalization or maintenance).
Several neuroimaging studies have found that individuals with ASD underactivate key brain regions involved in social cognition. However, there is also evidence to suggest that factors that increase attention to or interest in social stimuli are associated with more normal brain activity.
The purpose of this investigation is to examine the acute and sustained effects of social skills treatment on social cognition and the neural architecture that supports it. High-functioning children with ASD will be randomly assigned to a 12-week cognitive behavioral social skills group or a social play-based therapy group. For both types of groups, a parent session will be held concurrently. Functional MRI scans as well as behavioral assessments of social cognition, adaptive functioning, and symptom severity will be acquired at baseline, immediately following treatment, and at a 3-month follow-up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 8 to 11 years of age
- Meets criteria for ASD according to psychiatric interview (DSM-IV), the Autism Diagnostic Observation Schedule-Generic, and the Autism Diagnostic Interview-Revised
- Verbal IQ ≥ 70, as measured by the Wechsler Intelligence Scale for Children-Fourth Edition or Wechsler Abbreviated Scale of Intelligence
- History of psychiatric or neurological disorders other than ASD (e.g., schizophrenia, depression, seizure disorder)
- Within 30 days prior to the initial evaluation, beginning any new psychotropic medication or other therapeutic intervention (e.g., behavior, speech, physical/occupational, cognitive, nutritional therapy) that would confound the evaluation of the social skills groups
- Gross structural abnormality present in the brain (e.g., aneurysm)
- History of head trauma or loss of consciousness
- For any reason the child or parents appear unable to participate in study procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy Group Cognitive Behavioral Therapy (CBT) - Social Play Group Play Therapy -
- Primary Outcome Measures
Name Time Method Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2) Week 24 Assesses emotion recognition from facial expression, tone of voice, and posture. This instrument allows for the assessment of basic emotions conveyed by both adult and child models at high and low intensity. Nowicki and Carton \[50\] have shown that the DANVA2 has acceptable internal consistency for school age children and good test-retest reliability.
Reading the Mind in the Eyes Task - Child Version Week 24 The computerized children's version of the Eyes test is a reduced battery of 28-items measuring an individual's ability to interpret intentions and 'mentalizing' abilities, a hallmark social cognitive deficit in ASD. The adult RMET has shown sensitivity to change in clinical trials and the child version showed promising results in our preliminary analyses (see Preliminary Studies).
Functional Magnetic Resonance Imaging (fMRI) Week 24 We previously developed two activation tasks that tap different aspects of social cognition: 1) Interpreting Communicative Intent: Participants will view cartoon drawings of children while listening to short vignettes ending with a potentially ironic remark. Participants decide whether the speaker really meant what s/he said. 2) Affect and eye contact: Participants will view full-face pictures of people displaying happy, angry, fearful, or neutral affect. For each emotion, half of the faces show a direct gaze and half show a gaze aversion.
- Secondary Outcome Measures
Name Time Method Social Responsiveness Scale (SRS) Week 24 The SRS measures the severity of social impairment in natural settings, assessing social awareness, social information processing, reciprocal social communication, social anxiety/avoidance, and autistic preoccupations. This assessment will be completed by the child's parents and a classroom teacher, blind to intervention status, to reflect the opinion of more than one rater and allow for assessment of generalization across settings.
Strange Stories Task Week 24 These stories assess the ability to interpret nonliteral statements. Stories requiring the interpretation of a speaker's communicative intent will be read to participants. Questions probe whether the child understands that (a) a nonliteral statement has been made and (b) the intent behind the statement (i.e., was the speaker was lying, being sarcastic, joking?)
Vineland Adaptive Behavior Scales, Second Edition (Vineland II) Week 12 The Vineland II measures personal and social skills needed for everyday living. The Survey Form will be administered to the child's parents in a semi-structured interview format and the Teacher Checklist will be completed by a teacher blind to intervention status.
Autism Diagnostic Observation Schedule (ADOS) Week 12 Direct Observation 12 weeks (during treatment sessions) Structured direct observation procedures by blinded observers will be used to evaluate the following target behaviors: instrumental initiations, social initiations, response to initiations, and nonverbal behaviors. Direct observations will also be conducted during unstructured free-play sessions at baseline, mid-point, and endpoint.
Peer generalization assessment Week 12 An analogue play group will be used to evaluate generalization of treatment effects to unaffected, unfamiliar peers. The play group will consist of 4 children: 2 TD peers and 2 children with ASD (1 enrolled in CBT, 1 enrolled in social play). The analogue play session will consist of a 20-minute videotaped free-play period in which children are provided with cooperative play toys (e.g., make-believe, construction, and board games).
Trial Locations
- Locations (1)
Mount Sinai School of Medicine - Seaver Autism Center
🇺🇸New York, New York, United States