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

Schizophrenia Spectrum and Other Psychotic Disorders Clinical Trial

— SST  

Official title:

Social Skills Coach: An Innovative Multi-Platform Device to Address Social Impairments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053557
• Other study ID #: Social Skills Coach
• Secondary ID: 1R43MH113424-01
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: Center for Social Innovation, Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 30, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders

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.

Locations

Country	Name	City	State
United States	Center for Social Innovation	Needham	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Center for Social Innovation, Massachusetts	National Institute of Mental Health (NIMH), University of Maryland, VA Maryland Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved	Study Process: Recruitment, Retention, Troubleshooting	4 weeks post intervention
Primary	Credibility: Mean greater than 6 on Expectancy Rating Scale	Expectancy Rating Scale collected from client participants	4 weeks post intervention
Primary	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	4 weeks post intervention