AutismNCT01190917
Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)
A study testing Cognitive Behavioral Therapy (CBT) and Play Therapy in people with Autism and Autism Spectrum Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Play Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine - Seaver Autism Center
New York, New York, 10029
About this study
Official title: Acute and Sustained Effects of Social Skills Intervention on Neural and Behavioral Outcomes in Children With ASD
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.
Read the 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.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Cognitive Behavioral Therapy (CBT), Play Therapy
- 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
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Disease, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
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.
Play TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy Group | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Social Play Group | Active comparator | Not described Receives: Behavioral: Play Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0
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.
Measured: Week 12
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.
Measured: Week 24
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).
Measured: Week 0
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).
Measured: Week 12
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).
Measured: Week 24
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.
Measured: Week 0
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.
Measured: Week 12
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.
Measured: Week 24
Secondary outcomes (13)
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.
Measured: Week 0
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.
Measured: Week 12
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.
Measured: Week 24
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?)
Measured: Week 0
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?)
Measured: Week 12
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?)
Measured: Week 24
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.
Measured: Week 0
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.
Measured: Week 12
Autism Diagnostic Observation Schedule (ADOS)
Measured: Week 0
Autism Diagnostic Observation Schedule (ADOS)
Measured: Week 12
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.
Measured: 12 weeks (during treatment sessions)
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).
Measured: Week 0
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).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ting Wang, Ph.D., Principal investigator, Icahn School of Medicine at Mount SinaiLatha Soorya, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190917
- Sponsor's protocol ID
- GCO #09-0859
- Other IDs
- R21MH089236
- Status last verified
- Oct 2012
- First submitted
- 20 Aug 2010
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25721186
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Sustained Effects of Social Skills Intervention on Neural and Behavioral Outcomes in Children With ASD
- ClinicalTrials.gov ID
- NCT01190917
- Acronym / sponsor ID
- GCO #09-0859
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- Autism, Autism Spectrum Disorder, Disorder, Autistic, Asperger Syndrome, social skills group, behavioral intervention, Imaging, Magnetic Resonance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy Group | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT) |
| Social Play Group | Active comparator | Behavioral: Play Therapy |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive Behavioral Therapy Group |
| Play TherapyThe 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. | Behavioural | Social Play Group |
Primary outcome
Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
Time frame: Week 0
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
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
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
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
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
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
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
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
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.
13 secondary outcomes
Social Responsiveness Scale (SRS)
Time frame: Week 0
Social Responsiveness Scale (SRS)
Time frame: Week 12
Social Responsiveness Scale (SRS)
Time frame: Week 24
Strange Stories Task
Time frame: Week 0
Strange Stories Task
Time frame: Week 12
Strange Stories Task
Time frame: Week 24
Vineland Adaptive Behavior Scales, Second Edition (Vineland II)
Time frame: Week 0
Vineland Adaptive Behavior Scales, Second Edition (Vineland II)
Time frame: Week 12
Autism Diagnostic Observation Schedule (ADOS)
Time frame: Week 0
Autism Diagnostic Observation Schedule (ADOS)
Time frame: Week 12
Direct Observation
Time frame: 12 weeks (during treatment sessions)
Peer generalization assessment
Time frame: Week 0
Peer generalization assessment
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Derived from this study: PubMed 25721186Soorya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Wang, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
Latha Soorya, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and Play Therapy in people with Autism and Autism Spectrum Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2) (time frame: Week 0). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01190917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.