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Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)

Primary Purpose

Autism, Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Play Therapy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Autism Spectrum Disorder, Disorder, Autistic, Asperger Syndrome, social skills group, behavioral intervention, Imaging, Magnetic Resonance, fMRI, Functional MRI, MRI, Functional, Magnetic Resonance Imaging, Functional

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Mount Sinai School of Medicine - Seaver Autism Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive Behavioral Therapy Group

Social Play Group

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
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.
Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
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.
Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
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
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).
Reading the Mind in the Eyes Task - Child Version
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).
Reading the Mind in the Eyes Task - Child Version
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)
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.
Functional Magnetic Resonance Imaging (fMRI)
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.
Functional Magnetic Resonance Imaging (fMRI)
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

Social Responsiveness Scale (SRS)
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.
Social Responsiveness Scale (SRS)
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.
Social Responsiveness Scale (SRS)
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
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?)
Strange Stories Task
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?)
Strange Stories Task
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)
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.
Vineland Adaptive Behavior Scales, Second Edition (Vineland II)
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)
Autism Diagnostic Observation Schedule (ADOS)
Direct Observation
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
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).
Peer generalization assessment
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).

Full Information

First Posted
August 20, 2010
Last Updated
October 1, 2012
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01190917
Brief Title
Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)
Official Title
Acute and Sustained Effects of Social Skills Intervention on Neural and Behavioral Outcomes in Children With ASD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder
Keywords
Autism, Autism Spectrum Disorder, Disorder, Autistic, Asperger Syndrome, social skills group, behavioral intervention, Imaging, Magnetic Resonance, fMRI, Functional MRI, MRI, Functional, Magnetic Resonance Imaging, Functional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy Group
Arm Type
Active Comparator
Arm Title
Social Play Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
The CBT social skills curriculum is manualized and anchored in CBT strategies, such as problem identification, affective education, performance feedback, and weekly homework activities to facilitate generalization. The curriculum is a compilation of lessons targeting key social deficits in children with ASD, such as nonverbal communication, emotion recognition, and theory of mind. Structured teaching includes defining skills, breaking them down into simple, concrete steps, modeling the skill through role-play, and introducing a game or activity to practice the target skill. The approach to the parent group will be psychoeducational with a focus on reviewing target skills, rationale for teaching target skills, homework, progress or obstacles, and identifying strategies to promote generalization. Parent information handouts will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Play Therapy
Intervention Description
The social play group is manualized, led by a trained clinician and support staff, follows a specific routine, and contains a parent group component. Group leaders will follow participants' interests and suggestions for games. Group leaders utilize strategies such as reflective functioning statements on the child's behaviors to build emotion-focused play skills. The therapeutic setting incorporates play designed to encourage emotion-focused play including make-believe (dolls, houses), sensory (e.g. play-doh), and cooperative play (e.g. board games) toys. The approach to the parent group will be supportive rather than psychoeducational. Parents will set the agenda for discussion, facilitated by the group leader.
Primary Outcome Measure Information:
Title
Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
Description
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.
Time Frame
Week 0
Title
Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
Description
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.
Time Frame
Week 12
Title
Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
Description
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.
Time Frame
Week 24
Title
Reading the Mind in the Eyes Task - Child Version
Description
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).
Time Frame
Week 0
Title
Reading the Mind in the Eyes Task - Child Version
Description
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).
Time Frame
Week 12
Title
Reading the Mind in the Eyes Task - Child Version
Description
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).
Time Frame
Week 24
Title
Functional Magnetic Resonance Imaging (fMRI)
Description
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.
Time Frame
Week 0
Title
Functional Magnetic Resonance Imaging (fMRI)
Description
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.
Time Frame
Week 12
Title
Functional Magnetic Resonance Imaging (fMRI)
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS)
Description
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.
Time Frame
Week 0
Title
Social Responsiveness Scale (SRS)
Description
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.
Time Frame
Week 12
Title
Social Responsiveness Scale (SRS)
Description
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.
Time Frame
Week 24
Title
Strange Stories Task
Description
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?)
Time Frame
Week 0
Title
Strange Stories Task
Description
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?)
Time Frame
Week 12
Title
Strange Stories Task
Description
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?)
Time Frame
Week 24
Title
Vineland Adaptive Behavior Scales, Second Edition (Vineland II)
Description
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.
Time Frame
Week 0
Title
Vineland Adaptive Behavior Scales, Second Edition (Vineland II)
Description
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.
Time Frame
Week 12
Title
Autism Diagnostic Observation Schedule (ADOS)
Time Frame
Week 0
Title
Autism Diagnostic Observation Schedule (ADOS)
Time Frame
Week 12
Title
Direct Observation
Description
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.
Time Frame
12 weeks (during treatment sessions)
Title
Peer generalization assessment
Description
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).
Time Frame
Week 0
Title
Peer generalization assessment
Description
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).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Wang, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Latha Soorya, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine - Seaver Autism Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25721186
Citation
Soorya LV, Siper PM, Beck T, Soffes S, Halpern D, Gorenstein M, Kolevzon A, Buxbaum J, Wang AT. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):208-216.e1. doi: 10.1016/j.jaac.2014.12.005. Epub 2014 Dec 20.
Results Reference
derived
Links:
URL
http://www.seaverautismcenter.org
Description
Information about the Seaver Center

Learn more about this trial

Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)

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