Clinical trial NCT03053557: Testing a New Device to Advance the Use of Social Skills Training With Mental Health Consumers and Clinicians
Official title: Social Skills Coach: An Innovative Multi-Platform Device to Address Social Impairments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: mental health consumers
Lead sponsor: Center for Social Innovation, Massachusetts
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: VA Maryland Health Care System
name: National Institute of Mental Health (NIMH)
First posted: 2017-02-15
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Convergent parallel mixed methods
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved
timeFrame: 4 weeks post intervention
measure: Credibility: Mean greater than 6 on Expectancy Rating Scale
timeFrame: 4 weeks post intervention
measure: Acceptability: 80% of participants engage at least once; 50% of group attendees enter personalized goals; 50% of participants enter an evaluation goal
timeFrame: 4 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Needham
country: United States
facility: Center for Social Innovation
state: Massachusetts
Study officials:
affiliation: Center for Social Innovation
name: Jeff Olivet, MA
role: PRINCIPAL_INVESTIGATOR
References: