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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01190917
First received: August 20, 2010
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Autism
Autism Spectrum Disorder
Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Play Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute and Sustained Effects of Social Skills Intervention on Neural and Behavioral Outcomes in Children With ASD

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Autism Diagnostic Observation Schedule (ADOS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Direct Observation [ Time Frame: 12 weeks (during treatment sessions) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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).


Enrollment: 50
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Behavioral Therapy Group Behavioral: Cognitive Behavioral Therapy (CBT)
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.
Active Comparator: Social Play Group Behavioral: Play Therapy
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190917

Locations
United States, New York
Mount Sinai School of Medicine - Seaver Autism Center
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Ting Wang, Ph.D. Mount Sinai School of Medicine
Principal Investigator: Latha Soorya, Ph.D. Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01190917     History of Changes
Other Study ID Numbers: GCO #09-0859, R21MH089236
Study First Received: August 20, 2010
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
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

Additional relevant MeSH terms:
Disease
Autistic Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014