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

NCT ID: NCT03053557

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2018-09-30

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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Social Skills Coach

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland

OTHER

Sponsor Role: collaborator

VA Maryland Health Care System

FED

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Center for Social Innovation, Massachusetts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Olivet, MA

Role: PRINCIPAL_INVESTIGATOR

Center for Social Innovation

Locations

Center for Social Innovation

Needham, Massachusetts, United States

Countries

United States

Other Identifiers

1R43MH113424-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Social Skills Coach

Identifier Type: -

Identifier Source: org_study_id