Testing a New Device to Advance the Use of Social Skills Training With Mental Health Consumers and Clinicians (SST)
Primary Purpose
Schizophrenia Spectrum and Other Psychotic Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Skills Coach
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia Spectrum and Other Psychotic Disorders focused on measuring mental health consumers
Eligibility 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.
Sites / Locations
- Center for Social Innovation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Social Skills Coach
Social Skills Training course
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved
Study Process: Recruitment, Retention, Troubleshooting
Credibility: Mean greater than 6 on Expectancy Rating Scale
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
Web diagnostics and through Qualitative interviews with client participants and SST trainer participants
Secondary Outcome Measures
Full Information
NCT ID
NCT03053557
First Posted
February 9, 2017
Last Updated
October 5, 2018
Sponsor
Center for Social Innovation, Massachusetts
Collaborators
University of Maryland, VA Maryland Health Care System, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03053557
Brief Title
Testing a New Device to Advance the Use of Social Skills Training With Mental Health Consumers and Clinicians
Acronym
SST
Official Title
Social Skills Coach: An Innovative Multi-Platform Device to Address Social Impairments
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Social Innovation, Massachusetts
Collaborators
University of Maryland, VA Maryland Health Care System, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Spectrum and Other Psychotic Disorders
Keywords
mental health consumers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Convergent parallel mixed methods
Masking
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.
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Skills Coach
Arm Type
Experimental
Arm Description
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.
Arm Title
Social Skills Training course
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved
Description
Study Process: Recruitment, Retention, Troubleshooting
Time Frame
4 weeks post intervention
Title
Credibility: Mean greater than 6 on Expectancy Rating Scale
Description
Expectancy Rating Scale collected from client participants
Time Frame
4 weeks post intervention
Title
Acceptability: 80% of participants engage at least once; 50% of group attendees enter personalized goals; 50% of participants enter an evaluation goal
Description
Web diagnostics and through Qualitative interviews with client participants and SST trainer participants
Time Frame
4 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Olivet, MA
Organizational Affiliation
Center for Social Innovation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Social Innovation
City
Needham
State/Province
Massachusetts
ZIP/Postal Code
02494
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Testing a New Device to Advance the Use of Social Skills Training With Mental Health Consumers and Clinicians
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