Schizophrenia Spectrum and Other Psychotic DisordersSSTNCT03053557
Testing a New Device to Advance the Use of Social Skills Training With Mental Health Consumers and Clinicians
A study testing Social Skills Coach in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Center for Social Innovation, Massachusetts at 1 site in United States.
Trial summary
This study aims to test a new device called the Social Skills Coach that is being created to help mental health consumers with social skills and community functioning. People diagnosed with schizophrenia and clinicians will be included as participants in this study. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Social Skills Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 30 Sep 2018
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chart diagnosis of schizophrenia spectrum disorder, ability to provide consent, and independent living in the community.
- We will obtain written informed consent, and the consent procedure will include an evaluation of capacity to provide consent
Who cannot join
- Under age 21 or not able to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Social Innovation
Needham, Massachusetts, 02494
About this study
Official title: Social Skills Coach: An Innovative Multi-Platform Device to Address Social Impairments
This study aims to test a new device called the Social Skills Coach that is being created to help mental health consumers with social skills and community functioning. People diagnosed with schizophrenia and clinicians will be included as participants in this study. Mental health consumers (diagnosed with schizophrenia) will be randomly assigned to either test the new device or to participate in a social skills training course. Data will be collected from participants through surveys before participants either use the device or participate the course and afterwards. Individual interviews will be conducted with a sub sample of mental health consumers and clinicians. The study looks to test the credibility and acceptability of the new device to help mental health consumers and clinicians. it will also influence future research.
Read the detailed description
This phase I pilot study tests the feasibility, credibility, and acceptability of the prototype version of Social Skills Coach in terms of its use among mental health consumers and clinicians. The intervention aims to improve social and daily living skills and community functioning among people diagnosed with schizophrenia spectrum disorder. A mixed methods approach will be taken to collect quantitative data at baseline and follow-up. Quantitative data collection includes the use of surveys that comprise validated instruments. Qualitative data collection will occur at the end of the study and will include the use of semi-structured interviews to capture experiential information. Study participants will be randomly assigned to either a social skills training course (control group) or to a study arm using the Social Skills Coach program (treatment group). The study aims to demonstrate proof of concept for a larger effectiveness trial.
- Being tested
- Social Skills Coach
- Keywords
- mental health consumers
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Skills CoachBehavioural
Social Skills Coach is a multi-platform interactive device that engages users with information and skills learned in social skills training programs. The program includes a web application and provider dashboard and encourages users to practice skills on the app and use them in the real world and then report how the application of skills was experienced.
| Study group | Role | What they receive |
|---|---|---|
| Social Skills Coach | Experimental | The Social Skills Coach arm of the study will be provided access, instruction, and support for using the newly developed multi-platform device to address social impairments among individuals with schizophrenia, based on the evidence-based Social Skills Training (SST) intervention. Receives: Behavioral: Social Skills Coach |
| Social Skills Training course | No intervention | Social Skills Training classes are widely available and regularly used in the study setting. As such, this group will serve as a treatment as usual control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved
Study Process: Recruitment, Retention, Troubleshooting
Measured: 4 weeks post intervention
Credibility: Mean greater than 6 on Expectancy Rating Scale
Expectancy Rating Scale collected from client participants
Measured: 4 weeks post intervention
Acceptability: 80% of participants engage at least once; 50% of group attendees enter personalized goals; 50% of participants enter an evaluation goal
Web diagnostics and through Qualitative interviews with client participants and SST trainer participants
Measured: 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start2 Jan 2018
- Primary completion15 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum and Other Psychotic DisordersStudies 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
- Parallel groups
- Model description
- Convergent parallel mixed methods
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Social Innovation, Massachusetts
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, VA Maryland Health Care System, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jeff Olivet, MA, Principal investigator, Center for Social Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053557
- Sponsor's protocol ID
- Social Skills Coach
- Other IDs
- 1R43MH113424-01
- Acronym
- SST
- Status last verified
- Oct 2018
- First submitted
- 9 Feb 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be password protected and stored on secure severs. Access will be restricted to only the study team. When data is shared between team members it will be deidentified. All researchers on this project will have completed human subjects training and training specific to study protocols.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Skills Coach: An Innovative Multi-Platform Device to Address Social Impairments
- ClinicalTrials.gov ID
- NCT03053557
- Acronym / sponsor ID
- SST / Social Skills Coach
- Keywords
- mental health consumers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Center for Social Innovation, MassachusettsUniversity, hospital or other
- Collaborators
- University of Maryland, VA Maryland Health Care System, National Institute of Mental Health (NIMH)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- 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.
This study aims to test a new device called the Social Skills Coach that is being created to help mental health consumers with social skills and community functioning. People diagnosed with schizophrenia and clinicians will be included as participants in this study. Mental health consumers (diagnosed with schizophrenia) will be randomly assigned to either test the new device or to participate in a social skills training course. Data will be collected from participants through surveys before participants either use the device or participate the course and afterwards. Individual interviews will be conducted with a sub sample of mental health consumers and clinicians. The study looks to test the credibility and acceptability of the new device to help mental health consumers and clinicians. it will also influence future research.
Detailed description
This phase I pilot study tests the feasibility, credibility, and acceptability of the prototype version of Social Skills Coach in terms of its use among mental health consumers and clinicians. The intervention aims to improve social and daily living skills and community functioning among people diagnosed with schizophrenia spectrum disorder. A mixed methods approach will be taken to collect quantitative data at baseline and follow-up. Quantitative data collection includes the use of surveys that comprise validated instruments. Qualitative data collection will occur at the end of the study and will include the use of semi-structured interviews to capture experiential information. Study participants will be randomly assigned to either a social skills training course (control group) or to a study arm using the Social Skills Coach program (treatment group). The study aims to demonstrate proof of concept for a larger effectiveness trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Convergent parallel mixed methods
| Arm | Type | Receives |
|---|---|---|
| Social Skills Coach | Experimental | Behavioral: Social Skills CoachThe Social Skills Coach arm of the study will be provided access, instruction, and support for using the newly developed multi-platform device to address social impairments among individuals with schizophrenia, based on the evidence-based Social Skills Training (SST) intervention. |
| Social Skills Training course | No intervention | –Social Skills Training classes are widely available and regularly used in the study setting. As such, this group will serve as a treatment as usual control group. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chart diagnosis of schizophrenia spectrum disorder, ability to provide consent, and independent living in the community.
- We will obtain written informed consent, and the consent procedure will include an evaluation of capacity to provide consent
Key exclusion criteria (1 listed)
- Under age 21 or not able to provide consent.
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 |
|---|---|---|
| Social Skills CoachSocial Skills Coach is a multi-platform interactive device that engages users with information and skills learned in social skills training programs. The program includes a web application and provider dashboard and encourages users to practice skills on the app and use them in the real world and then report how the application of skills was experienced. | Behavioural | Social Skills Coach |
Primary outcome
Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved
Time frame: 4 weeks post intervention
Study Process: Recruitment, Retention, Troubleshooting
Credibility: Mean greater than 6 on Expectancy Rating Scale
Time frame: 4 weeks post intervention
Expectancy Rating Scale collected from client participants
Acceptability: 80% of participants engage at least once; 50% of group attendees enter personalized goals; 50% of participants enter an evaluation goal
Time frame: 4 weeks post intervention
Web diagnostics and through Qualitative interviews with client participants and SST trainer participants
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 9 Oct 2018.
- Individual participant dataSharing planned: No. Data will be password protected and stored on secure severs. Access will be restricted to only the study team. When data is shared between team members it will be deidentified. All researchers on this project will have completed human subjects training and training specific to study protocols.
Related trials for Schizophrenia Spectrum and Other Psychotic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
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.
Jeff Olivet, MA principal investigator
Center for Social Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Skills Coach in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Center for Social Innovation, Massachusetts 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 2 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 9 Oct 2018. 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?
Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved (time frame: 4 weeks post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2018.