Autism Spectrum DisorderNCT03368001
Investigating Social Competence in Youth With Autism
A study testing SENSE Theatre and Tackling Teenage Together in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- SENSE Theatre and Tackling Teenage Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Nov 2017to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with high-functioning ASD (IQ > or = to 70).
Who cannot join
- Children who evidence aggression toward other people.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Stony Brook University
Stony Brook, New York, 11794
University of Alabama
Tuscaloosa, Alabama, 35487
About this study
Official title: Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial
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).
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- SENSE Theatre, Tackling Teenage Together
- Keywords
- Autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE TheatreBehavioural
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).
Tackling Teenage TogetherBehavioural
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: SENSE Theatre |
| 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. Receives: Behavioral: Tackling Teenage Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to end of treatment (10 weeks) and at two-month follow-up.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-treatment (10 weeks), and two-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start22 Nov 2017
- Primary completion15 Aug 2022
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blythe Corbett, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368001
- Sponsor's protocol ID
- 171153
- Status last verified
- Sep 2024
- First submitted
- 5 Dec 2017
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Currently sharing with the National Database for Autism Research.
Publications
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.
PubMed 37199977
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03368001
- Acronym / sponsor ID
- 171153
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SENSE Theatre | Experimental | Behavioral: SENSE TheatreSENSE 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). |
| Tackling Teenage Together | Active comparator | Behavioral: Tackling Teenage TogetherThe Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with high-functioning ASD (IQ > or = to 70).
Key exclusion criteria (1 listed)
- Children who evidence aggression toward other people.
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 |
|---|---|---|
| SENSE TheatreSENSE 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). | Behavioural | SENSE Theatre |
| Tackling Teenage TogetherThe Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions. | Behavioural | Tackling Teenage Together |
Primary outcome
Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed
Time frame: Change from baseline to end of treatment (10 weeks).
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.
Incidental Face Memory (IFM) Event-Related Potential (ERP) Task
Time frame: Change from baseline to end of treatment (10 weeks) and at two-month follow-up.
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.
4 secondary outcomes
Social Responsiveness Scale (SRS) Communication
Time frame: Baseline, post-treatment (10 weeks), and two-month follow-up.
Adaptive Behavior Scales for Children (ABAS)
Time frame: Baseline, post-treatment (10 weeks), and two-month follow-up.
Contextual Assessment of Social Skills (CASS) Interested
Time frame: Baseline, post-treatment (10 weeks), and two-month follow-up.
Child Behavior Checklist (CBCL)
Time frame: Baseline, post-treatment (10 weeks), and two-month follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37199977Corbett 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.
- Individual participant dataSharing planned: Yes. Currently sharing with the National Database for Autism Research.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSE Theatre and Tackling Teenage Together in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 3 sites 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 1 inclusion and 1 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed (time frame: Change from baseline to end of treatment (10 weeks).). The study lists 2 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 NCT03368001, 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 8 Oct 2024.