Autism Spectrum DisorderNCT02276534
SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)
A study testing SENSE Theatre and Delayed Intervention in people with Autism Spectrum Disorder, run by Vanderbilt University at 1 site in United States.
Trial summary
The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. 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 Delayed Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to May 2017
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children diagnosed with autism spectrum disorder with IQ ≥ to 70.
Who cannot join
- IQ ≤ 70, children with current aggression toward self or others.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Kennedy Center
Nashville, Tennessee, 37203
About this study
Official title: SENSE Theatre Research Program
The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.
Read the detailed description
The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.
Objectives: The purpose of the study is to evaluate and extend the impact of a peer-mediated, theatre-based intervention on children with ASD with an emphasis on social functioning. The 10-session program incorporates theatrical approaches, trained typically developing peers and established behavioral strategies. Previous studies using pre-post designs have reported improvement in several skills, such as face memory, theory of mind and social cognition. A primary objective of this investigation is to utilize a true experimental design while evaluating social ability across multiple levels of analysis including neuropsychological, cognitive, behavioral, and functional outcomes.
- Conditions
- Autism Spectrum Disorder
- Being tested
- SENSE Theatre, Delayed Intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE TheatreBehavioural
A peer-mediated, theatre-based intervention.
Delayed InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Theatre | Experimental | The participants will receive 10 sessions of peer-mediated, theatre-based intervention. Receives: Behavioral: SENSE Theatre |
| No Intervention then Theatre | Experimental | The participants will not receive the treatment for a period of time. Receives: Behavioral: Delayed Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEPSY Memory for faces
The measure requires the child to observe 16 faces of children and then remember them immediately and following a 30-minute delay. Raw scores are generated which are converted to standardized scores based on normative data.
Measured: Change from Baseline at Week 10 and Week 16
Measurement of Salivary Cortisol levels
Measured: Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes
Event Related Potentials (ERP) incidental memory task
Measured: Change from baseline at Week 10 and Week 16
Social Responsiveness Scale
Measured: Change from baseline at Week 10 and Week 16
Peer Interaction Playground Paradigm
A playground play session conducted with trained typically developing peers.
Measured: Change from baseline at Week 10 and Week 16
Adaptive Behavior Assessment System
Parent questionnaire of child's adaptive behavior
Measured: Change from baseline at Week 10 and Week 16
Parenting Stress Index
parent-based questionnaire
Measured: Change from baseline at Week 10 and Week 16
Secondary outcomes (2)
Clinical Evaluation of Fundamentals Recalling Sentences subtest
Measured: Change from baseline at Week 10 and Week 16
Peabody Picture Vocabulary Test
Measured: Change from baseline at Week 10 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Blythe Corbett, Vanderbilt University
- Investigators
- Blythe A Corbett, Ph.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276534
- Sponsor's protocol ID
- 110082
- Status last verified
- Jun 2017
- First submitted
- 15 Oct 2014
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Key AP, Corbett BA. The Unfulfilled Promise of the N170 as a Social Biomarker. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):342-353. doi: 10.1016/j.bpsc.2019.08.011. Epub 2019 Sep 13.
PubMed 31679960Corbett BA, Ioannou S, Key AP, Coke C, Muscatello R, Vandekar S, Muse I. Treatment Effects in Social Cognition and Behavior following a Theater-based Intervention for Youth with Autism. Dev Neuropsychol. 2019 Oct;44(7):481-494. doi: 10.1080/87565641.2019.1676244. Epub 2019 Oct 7.
PubMed 31589087
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENSE Theatre Research Program
- ClinicalTrials.gov ID
- NCT02276534
- Acronym / sponsor ID
- 110082
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Oct 2014 (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 investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.
Detailed description
The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.
Objectives: The purpose of the study is to evaluate and extend the impact of a peer-mediated, theatre-based intervention on children with ASD with an emphasis on social functioning. The 10-session program incorporates theatrical approaches, trained typically developing peers and established behavioral strategies. Previous studies using pre-post designs have reported improvement in several skills, such as face memory, theory of mind and social cognition. A primary objective of this investigation is to utilize a true experimental design while evaluating social ability across multiple levels of analysis including neuropsychological, cognitive, behavioral, and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theatre | Experimental | Behavioral: SENSE TheatreThe participants will receive 10 sessions of peer-mediated, theatre-based intervention. |
| No Intervention then Theatre | Experimental | Behavioral: Delayed InterventionThe participants will not receive the treatment for a period of time. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children diagnosed with autism spectrum disorder with IQ ≥ to 70.
Key exclusion criteria (1 listed)
- IQ ≤ 70, children with current aggression toward self or others.
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 TheatreA peer-mediated, theatre-based intervention. | Behavioural | Theatre |
| Delayed Intervention | Behavioural | No Intervention then Theatre |
Primary outcome
NEPSY Memory for faces
Time frame: Change from Baseline at Week 10 and Week 16
The measure requires the child to observe 16 faces of children and then remember them immediately and following a 30-minute delay. Raw scores are generated which are converted to standardized scores based on normative data.
Measurement of Salivary Cortisol levels
Time frame: Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes
Event Related Potentials (ERP) incidental memory task
Time frame: Change from baseline at Week 10 and Week 16
Social Responsiveness Scale
Time frame: Change from baseline at Week 10 and Week 16
Peer Interaction Playground Paradigm
Time frame: Change from baseline at Week 10 and Week 16
A playground play session conducted with trained typically developing peers.
Adaptive Behavior Assessment System
Time frame: Change from baseline at Week 10 and Week 16
Parent questionnaire of child's adaptive behavior
Parenting Stress Index
Time frame: Change from baseline at Week 10 and Week 16
parent-based questionnaire
2 secondary outcomes
Clinical Evaluation of Fundamentals Recalling Sentences subtest
Time frame: Change from baseline at Week 10 and Week 16
Peabody Picture Vocabulary Test
Time frame: Change from baseline at Week 10 and Week 16
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 14 Jun 2017.
- Derived from this study: PubMed 31679960Key AP, Corbett BA. The Unfulfilled Promise of the N170 as a Social Biomarker. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):342-353. doi: 10.1016/j.bpsc.2019.08.011. Epub 2019 Sep 13.
- Derived from this study: PubMed 31589087Corbett BA, Ioannou S, Key AP, Coke C, Muscatello R, Vandekar S, Muse I. Treatment Effects in Social Cognition and Behavior following a Theater-based Intervention for Youth with Autism. Dev Neuropsychol. 2019 Oct;44(7):481-494. doi: 10.1080/87565641.2019.1676244. Epub 2019 Oct 7.
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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.
Blythe A Corbett, Ph.D. principal investigator
Vanderbilt University
1 site 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 Delayed Intervention in people with Autism Spectrum Disorder, run by Vanderbilt University 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 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 14 Jun 2017. 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?
NEPSY Memory for faces (time frame: Change from Baseline at Week 10 and Week 16). The study lists 7 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 NCT02276534, which also lists 2 linked publications.
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 14 Jun 2017.