Testing a New Device to Advance the Use of Social Skills Training With Mental Health Consumers and Clinicians (SST)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia Spectrum and Other Psychotic Disorders	Behavioral: Social Skills Coach	Not Applicable

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	36 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Convergent parallel mixed methods
Masking:	Single (Outcomes Assessor)
Masking Description:	Research assistants who conduct assessments with participants will be blinded as to whether participants have been assigned to the intervention or control group.
Primary Purpose:	Treatment
Official Title:	Social Skills Coach: An Innovative Multi-Platform Device to Address Social Impairments
Actual Study Start Date :	January 2, 2018
Estimated Primary Completion Date :	March 1, 2018
Estimated Study Completion Date :	March 31, 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Social Skills Coach; 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.	Behavioral: Social Skills Coach; 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.
No Intervention: Social Skills Training course; 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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved [ Time Frame: 4 weeks post intervention ]
   Study Process: Recruitment, Retention, Troubleshooting
2. Credibility: Mean greater than 6 on Expectancy Rating Scale [ Time Frame: 4 weeks post intervention ]
   Expectancy Rating Scale collected from client participants
3. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Under age 21 or not able to provide consent.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Jeff Olivet, MA	617-467-6014	jolivet@center4si.com
Contact: Kathleen Ferreira, PhD	352-212-2616	kferreira@center4si.com

Locations

United States, Massachusetts
Center for Social Innovation	Recruiting
Needham, Massachusetts, United States, 02494
Contact: Jeffrey Olivet, MA 617-467-6014 jolivet@center4si.com
Contact: Kathleen Ferreira, PhD 352-212-2616 kferreira@center4si.com
Principal Investigator: Jeff Olivet, MA

Sponsors and Collaborators

Center for Social Innovation, Massachusetts

University of Maryland

VA Maryland Health Care System

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Jeff Olivet, MA	Center for Social Innovation

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Center for Social Innovation, Massachusetts
ClinicalTrials.gov Identifier:	NCT03053557 History of Changes
Other Study ID Numbers:	Social Skills Coach; 1R43MH113424-01 ( U.S. NIH Grant/Contract )
First Posted:	February 15, 2017
Last Update Posted:	January 10, 2018
Last Verified:	January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	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.

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Center for Social Innovation, Massachusetts:

mental health consumers

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders