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

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ClinicalTrials.gov Identifier: NCT03053557
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : January 10, 2018
Sponsor:
Collaborators:
University of Maryland
VA Maryland Health Care System
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Center for Social Innovation, Massachusetts

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 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

Resource links provided by the National Library of Medicine


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.



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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053557


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

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    Key Record Dates
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