NCT03053557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

February 9, 2017

Last Update Submit

October 5, 2018

Conditions

Keywords

mental health consumers

Outcome Measures

Primary Outcomes (3)

  • Feasibility: 90% recruitment, 75% data completed, 80% technical problems solved

    Study Process: Recruitment, Retention, Troubleshooting

    4 weeks post intervention

  • Credibility: Mean greater than 6 on Expectancy Rating Scale

    Expectancy Rating Scale collected from client participants

    4 weeks post intervention

  • 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

Study Arms (2)

Social Skills Coach

EXPERIMENTAL

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 Training course

NO 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.

Interventions

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 Coach

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under age 21 or not able to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Social Innovation

Needham, Massachusetts, 02494, United States

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jeff Olivet, MA

    Center for Social Innovation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research assistants who conduct assessments with participants will be blinded as to whether participants have been assigned to the intervention or control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Convergent parallel mixed methods
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 15, 2017

Study Start

January 2, 2018

Primary Completion

August 15, 2018

Study Completion

September 30, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

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.

Locations