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Our treatment, SENSE Theatre, combines several well-documented, effective behavioral strategies and theatre techniques. The proposed project will extend previous findings showing improving improvement in memory for faces. The multisite randomized control trial will include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage Together).
Recent findings from a randomized control trial (RCT) show immediate between-group effects and evidence of target engagement on the hypothesized mechanism of action, memory for faces, which was evaluated by neuropsychological and event-related potential (ERP) measures. Moreover, the RCT demonstrated treatment effects on social communication skills that generalized to home and community settings. Finally, maintained treatment effects were observed on communication symptoms. The proposed project will extend these findings and provide a stronger test of efficacy using a multisite RCT of SENSE Theatre with a large sample of participants with ASD (8 to 16 years) randomized to an experimental and an active control group. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers. Thus, the overarching aim of the study is to determine whether detected changes in face memory and social interaction are due to the SENSE Theatre treatment and the extent to which these changes generalize and maintain. If predicted results occur, it will provide strong empirical support for a community-based treatment that has generalized effects on a set of core deficits that otherwise have life-long consequences for children and adolescents with ASD.
8/18/2021: Record was updated to delete the outcome measure "Computer memory for faces" as it was not included as a primary outcome variable in the Institutional Review Board (IRB) approved protocol dated 9/13/2017.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SENSE Theatre | Experimental | SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD). |
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| Tackling Teenage Together | Active Comparator | The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSE Theatre | Behavioral | SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD). |
| Measure | Description | Time Frame |
|---|---|---|
| Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed | A measure of face memory following a delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory. | Change from baseline to end of treatment (10 weeks). |
| Incidental Face Memory (IFM) Event-Related Potential (ERP) Task | The IFM involves passive viewing of novel faces one of which repeats. The dependent measure is the difference in ERP amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory. | Change from baseline to end of treatment (10 weeks) and at two-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Social Responsiveness Scale (SRS) Communication | The SRS is a measure of social competence that is administered by parents pertaining to behaviors characteristic of children with autism. Raw scores on the Social Communication domain range from 0 - 66. Higher scores indicate more impairment. Raw scores were used in the analyses. A decrease in scores from pre- to post-treatment suggests a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Tuscaloosa | Alabama | 35487 | United States | ||
| Stony Brook University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37199977 | Derived | Corbett BA, White S, Lerner M, Preacher KJ, Klemencic ME, Simmons GL, Pilkington J, Gable P, Gioia A, Key AP. Peers, play, and performance to build social salience in autistic youth: A multisite randomized clinical trial. J Consult Clin Psychol. 2023 Jul;91(7):411-425. doi: 10.1037/ccp0000821. Epub 2023 May 18. |
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Currently sharing with the National Database for Autism Research.
Data will be available after study completion and published all primary results.
Interested investigators must apply to National Database for Autism Research (NDAR) to receive access once it is made available.
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Excluded (n = 28) Not meeting inclusion criteria (n = 22) No longer interested (n = 2) Refused to participate (n = 3) Unable to contact (n = 1)
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| ID | Title | Description |
|---|---|---|
| FG000 | SENSE Theatre | SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD). SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD). |
| FG001 | Tackling Teenage Together | The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | SENSE Theatre | SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD). SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed | A measure of face memory following a delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory. | Unfortunately, collection of the data was not completed and improperly administered at one of the key study sites, rendering the data invalid. | Posted | Change from baseline to end of treatment (10 weeks). |
|
Baseline through study completion (on average, approximately 18 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SENSE Theatre | SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD). SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD). |
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There is data loss due to the Coronavirus -19 pandemic, which resulted in reduction in the number of participants who completed the study, data loss of specific primary variables, and differential attrition between the groups. This is reflected in Participant Flow.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Blythe Corbett, Ph.D. | Vanderbilt University Medical Center | 615-936-0280 | blythe.corbett@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2022 | Jun 29, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2017 | Feb 17, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 5, 2020 | Feb 17, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Tackling Teenage Together | Behavioral | The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. |
|
| Baseline, post-treatment (10 weeks), and two-month follow-up. |
| Adaptive Behavior Scales for Children (ABAS) | The ABAS is a parental rating scale pertaining to various adaptive behaviors in a child, such as social and communication skills. Standard scores for the subscales range from 1 to 19. Higher scores reflect better skills in each domain. The primary variable of interest was the Communication subscale, ranging from 1 to 19 with higher scores reflecting better communication skills. | Baseline, post-treatment (10 weeks), and two-month follow-up. |
| Contextual Assessment of Social Skills (CASS) Interested | The CASS is an observational measure of social interaction skills with two similar age peers. There are two conditions which include an Interested Condition and a Bored Condition. The behaviors will be coded based on raw scores from 1 to 7 with 7 reflecting better ability. Only the Interested Condition was analyzed. | Baseline, post-treatment (10 weeks), and two-month follow-up. |
| Child Behavior Checklist (CBCL) | The CBCL is a parent report measure of a variety of symptom domains relevant for children with autism and related neurodevelopment disorders. T scores range from 40 to 100 with a mean of 50 and a deviation of 10. Primary variable of interest was Social Problems. Higher scores indicate more social problems. T scores of 64 or higher are considered clinically significant. | Baseline, post-treatment (10 weeks), and two-month follow-up. |
| Stony Brook |
| New York |
| 11794 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
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| NOT COMPLETED |
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| BG001 | Tackling Teenage Together | The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Wechsler Abbreviated Scale of Intelligence (WASI) II Full Scale Intelligence Quotient (IQ) | The Wechsler Abbreviated Scale of Intelligence second edition (WASI-II) is composed of four subtests: Block Design, Vocabulary, Matrix Reasoning, and Similarities. The Full Scale IQ is derived from a summation of the subtests. The IQ Standard Score range is: 40-160. Higher scores mean better outcomes. | Mean | Standard Deviation | units on a scale |
|
| Autism Diagnostic Observation Schedule (ADOS) 2 Severity Scale | The Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) includes a standardized calibrated severity score (CSS). These scores, based on the ADOS-2 total algorithm raw score, range from 1-10, with individuals with ASD ranging from 6-10. The CSS provides a measure of an individual's severity of autistic-like symptoms during when compared to other ASD, regardless of chronological age and language level. Higher scores indicate greater symptom severity. | Mean | Standard Deviation | units on a scale |
|
| IFM Index | Event-related potential (ERP) Incidental Memory for Faces (IFM) Paradigm is a nonverbal and IQ-independent measure of social information processing. The IFM paradigm targets spontaneous formation of a memory trace for a novel face following repeated presentations. The associated increase in the parietal amplitudes reflects stimulus recall. The unit of measurement is microvolts (µV). IFM index is calculated as the amplitude difference for repeated faces versus single faces, where more positive scores indicate better IFM (greater memory trace for repeated faces). | Mean | Standard Deviation | µV |
|
| CASS Interested | The Contextual Assessment of Social Skills (CASS) is an ecologically valid social interaction protocol developed to ascertain several domains of social functioning in youth and young adults with ASD. The CASS features two conditions, Interested (CASS-I) and Bored (CASS-B). Only the CASS-I was used in the study. The DVs analyzed from the CASS included raw scores (range 1-7) for Vocal Expressiveness (varies the tempo, pitch, tone, volume, and/or rhythm of speech), Quality of Rapport (degree of rapport), and Social Anxiety (verbal, nonverbal). Higher scores suggest better functioning. | Mean | Standard Deviation | units on a scale |
|
| SRS-2 Communication | The Social Responsiveness Scale, Second Edition (SRS-2) is a parent-report measure of behavioral characteristic of autism for ages 2-18 years. Five domain scores are calculated. The standard T-score on the SRS-2 Communication Domain was selected as a treatment outcome. Higher T-scores indicate more impairment. The SRS-2 Communication Domain has a mean T-score of 50 with a standard deviation of 10. T-Scores falling in the range of 76 or higher are considered severe, or clinically significant; scores 66-75 are moderate; scores 60-65 are considered mild; and scores 59 or below are average. | Mean | Standard Deviation | T-Score |
|
| OG001 | Tackling Teenage Together | The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. |
|
| Primary | Incidental Face Memory (IFM) Event-Related Potential (ERP) Task | The IFM involves passive viewing of novel faces one of which repeats. The dependent measure is the difference in ERP amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory. | Number of participants analyzed at posttest. For follow-up the number of participants was SENSE Theatre N =101 and Tackling Teenage N = 79. | Posted | Mean | Standard Deviation | µV | Change from baseline to end of treatment (10 weeks) and at two-month follow-up. |
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| Secondary | Social Responsiveness Scale (SRS) Communication | The SRS is a measure of social competence that is administered by parents pertaining to behaviors characteristic of children with autism. Raw scores on the Social Communication domain range from 0 - 66. Higher scores indicate more impairment. Raw scores were used in the analyses. A decrease in scores from pre- to post-treatment suggests a better outcome. | Number of participants analyzed at posttest. Number of participants analyzed at two-month follow-up SENSE Theatre N = 101, Tackling Teenage N = 79. | Posted | Mean | Standard Deviation | Raw scores. | Baseline, post-treatment (10 weeks), and two-month follow-up. |
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| Secondary | Adaptive Behavior Scales for Children (ABAS) | The ABAS is a parental rating scale pertaining to various adaptive behaviors in a child, such as social and communication skills. Standard scores for the subscales range from 1 to 19. Higher scores reflect better skills in each domain. The primary variable of interest was the Communication subscale, ranging from 1 to 19 with higher scores reflecting better communication skills. | Number of participants analyzed at posttest. One participant in Tackling Teenage had missing data. The number of participants analyzed at two-month follow-up SENSE Theatre N=99, Tackling Teenage N=78. Two participants in SENSE Theatre and one in Tackling Teenage had missing data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, post-treatment (10 weeks), and two-month follow-up. |
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| Secondary | Contextual Assessment of Social Skills (CASS) Interested | The CASS is an observational measure of social interaction skills with two similar age peers. There are two conditions which include an Interested Condition and a Bored Condition. The behaviors will be coded based on raw scores from 1 to 7 with 7 reflecting better ability. Only the Interested Condition was analyzed. | Number of participants analyzed for Posttest. Number of participants analyzed for Follow-up SENSE Theatre N = 101, Tackling Teenage N = 79. | Posted | Mean | Standard Deviation | units on a scale | Baseline, post-treatment (10 weeks), and two-month follow-up. |
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| Secondary | Child Behavior Checklist (CBCL) | The CBCL is a parent report measure of a variety of symptom domains relevant for children with autism and related neurodevelopment disorders. T scores range from 40 to 100 with a mean of 50 and a deviation of 10. Primary variable of interest was Social Problems. Higher scores indicate more social problems. T scores of 64 or higher are considered clinically significant. | Number of participants analyzed at posttest. One participant in Tackling Teenage and two participants in SENSE Theatre had missing data. The number of participants analyzed at two-month follow-up SENSE Theatre N=98, Tackling Teenage N=78. Three participants in SENSE Theatre and one in Tackling Teenage had missing data. | Posted | Mean | Standard Deviation | T score | Baseline, post-treatment (10 weeks), and two-month follow-up. |
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| 0 |
| 114 |
| 0 |
| 114 |
| 0 |
| 114 |
| EG001 | Tackling Teenage Together | The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. | 0 | 93 | 0 | 93 | 0 | 93 |
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| IFM Follow-up |
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| Other |
We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses. We accounted for any non-independence of observations due to cohort membership by obtaining cluster-robust standard errors using robust maximum likelihood estimation (MLR in Mplus) in tandem with the Type = Complex option available in Mplus, treating cohorts as clusters. All models were structurally saturated, so model fit was necessarily perfect. |
| The indirect effect of SENSE Theatre® vs. TTT through post-test IFM on follow-up Vocal Expressiveness. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths. | Structural Equation Model (SEM) | Controlling for Verbal Expressiveness at Pretest and the interval between Pretest and the Followup assessments. | <0.05 | One-tailed significance test | Structural Equation Model (SEM) | 0.064 | 2-Sided | 90 | 0.014 | 0.118 | Estimation parameter represents indirect effect (axb) | Other | The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator. |
| The partially standardized indirect effect of treatment on follow-up Quality of Rapport through posttest Incidental Face Memory. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag (pretest to posttest) and baseline mediator, and controlled the outcome for individual differences in lag (pretest to follow-up) and baseline outcome. | Structural Equation Model (SEM) | Controlling for Rapport at Pretest and the interval between Pretest and the Followup assessments. | <0.05 | One-sided hypothesis test. | Structural Equation Model (SEM) | 0.032 | 2-Sided | 90 | 0.002 | 0.087 | Estimation parameter represents indirect effect (axb) | Other | The residual associated with the mediator was allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model. |
| The partially standardized indirect effect of treatment on follow-up Social Anxiety through posttest IFM. Adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths. | Structural Equation Model (SEM) | Controlling for Social Anxiety at Pretest and the interval between Pretest and the Followup assessments. | >0.05 | One-sided hypothesis test | Structural Equation Model (SEM) | 0.005 | 2-Sided | 90 | -0.015 | 0.059 | Estimation parameter represents indirect effect (axb) | Other | The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model. |
| The partially standardized indirect effect of treatment on follow-up SRS Communication. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths. | Structural Equation Model (SEM) | Controlling for SRS-2 Social Communication at Pretest and the interval between Pretest and the Followup assessments. | >0.05 | One-sided hypothesis test | Structural Equation Model (SEM) | -0.0002 | 2-Sided | 90 | -0.054 | 0.061 | Estimation parameter represents indirect effect (axb) | Other | The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model. |
| SRS Communication Follow-up |
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| ABAS Communication Followup |
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| Other |
Followup ANCOVA controlling for pretest values |
| Vocal Expressiveness Follow-up |
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| Quality of Rapport Posttest |
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| Quality of Rapport Follow-up |
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| Social Anxiety Posttest |
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| Social Anxiety Follow-up |
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| Structural Equation Modeling |
We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses |
| .448 |
| Other |
| Social Anxiety Posttest. | Structural Equation Modeling | We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses | .150 | Other |
| CBCL Social Problems Followup |
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| Other |
Followup ANCOVA controlling for pretest values. |