Feasibility of Mobile and Technology Assisted Aftercare Services for Crisis Stabilization Units

Substance Abuse Clinical Trial

Official title:

Multi-Site Feasibility Evaluation of Crisis Stabilization Units Across Three Jurisdictions With High Opioid Use Disorders and a Proposed Follow-Up RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04899934
• Other study ID #: STUDY00001570
• Secondary ID: 19-02811
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: March 20, 2023

Study information

• Verified date: June 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study investigators are examining the feasibility and acceptability of an expanded and technology-assisted aftercare program with persons released from a crisis stabilization unit (CSU) who were brought to the CSU by choice of law enforcement. Investigators are assessing the critical elements of CSUs, examining the feasibility and acceptability of pairing mobile and technology-assisted aftercare to improve treatment access and retention; and developing a study protocol to be used in a future multisite randomized controlled trial (RCT).

Crisis stabilization units provide law enforcement officers an alternative to jail for individuals experiencing a substance use or mental health disorder crisis contributing to criminalized behavior. This study is designed to assist with the diversion of individuals toward treatment and away from subsequent contact with law enforcement through piloting mobile and technology assisted aftercare services to persons released from a CSU. One of the largest barriers to the effectiveness of CSUs is retaining the individual in treatment after discharge. Logistical factors including transportation, stable housing, and long waitlists for community-based treatment decrease treatment access. These factors may also be complicated by an individual's understanding of the importance of remaining in treatment as well as their motivation to continue. To overcome these barriers and enhance the impact of CSUs, investigators are developing an expanded model which includes mobile and technology-assisted modalities that address psychological, behavioral, and medication-assisted treatment.

Description:

This study is a mixed methods design, combining a randomized controlled trial and qualitative interviews into the feasibility of the pilot program, mobile and technology assisted aftercare. The randomized controlled trial consists of a 1:1 comparison of the pilot CSU aftercare services and the treatment as usual (TAU) services for persons releasing from a CSU.

Participants (n=24) are recruited into the study prior to their discharge from a CSU. Research team members are alerted of potential eligible participants who meet study criteria and are soon-to-be discharged by CSU staff. At this point, research team members approach the eligible participants to conduct the recruitment and consent process. Due to the short length of stay in a CSU, the research team does one-to-one randomization and pre-randomize of the pool of participants prior to recruitment. For example, the pre-randomization may results in Tx Tx Ctrl Tx Ctrl Ctrl assignments for each sequential enrollment in the study. Or it may result in a different pattern Ctrl Txt Ctrl, etc. Participants are notified of their randomization status at the end of the consent and baseline data collection interview.

The pilot program of mobile and technology assisted aftercare service connects participants with a Community Support Specialist (CSS) who provides mobile aftercare (i.e., meet the client in their homes or other community settings) up to once a week for 6 months. Participants also have 24/7 access to behavioral health mobile applications on a smart phone. Mobile apps recommended to participants include, moodtools-depression aid, virtual hope box, recovery path, and intellicare hub. All mobile apps have undergone one or a combination of RCTs, clinical trials, and/or developed with mental health professionals.

Data is collected through participant interviews and collection of health and administrative records from agency collaborators. Participants will complete a total of 4 interviews over a period of 6 months. Baseline interviews will be conducted at study enrollment. Time 1 (T1) interviews will be conducted 2 weeks post-discharge from the CSU. Time 2 (T2) interviews will be conducted 3 months post-discharge from CSU. Time 3 (T3) will be conducted 6 months post-discharge from the CSU. The investigators are monitoring trends in participants during their participation in the pilot program and all consented participants for the treatment and control groups will complete a series of interviews. The assessed trends include readmission to a CSU, employment stability, financial stability, criminal justice involvement, perception of social support, use of acute and long-term services, and multiple psychosocial measures listed below.

Data assessing the feasibility and acceptability of the mobile and technology-assisted aftercare is also assessed through qualitative interviews and focus groups with our community mental health partner. This qualitative data will be used to create a protocol for CSU aftercare that can respond to diverse jurisdictional characteristics leading to CSU aftercare services that are feasible and scalable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 20, 2023
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• brought to Meridian Behavioral Health CSU by the choice of law enforcement

• over 18 years of age

• self-report to be residing in Alachua, Columbia, or Levy county for at least 6 months following their discharge from the CSU.

• conversational in English

• being able to cognitively consent

Exclusion Criteria:

• younger than 18 years old

• not cognitively able to consent

• not conversational in English

• not releasing from the CSU to Alachua, Columbia, or Levy County, Florida

• not brought to the CSU by choice of law enforcement

Related Conditions & MeSH terms

• Criminal Behavior
• Mental Disorder
• Mental Disorders
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• mobile and technology assisted aftercare
The mobile and technology assisted aftercare consists of mobile mental health professionals who travel to participants to provide mental health services including counseling, navigation of community referrals, motivational interviewing, solution focused therapy, psycho-education, and social support. Participants randomized to this condition will also receive 24/7 access to evidence-based behavioral health mobile applications that are recommended based on the participant's diagnostic status, learning style, and goals. Frequency of app use is up to the participant's discretion. However, during weekly aftercare sessions, the CSS may assist the participant with creation of an app use schedule that is realistic for the participant's needs and treatment goals.

Other:
• Treatment as usual
Treatment as usual services include a personalized discharge plan, a follow up appointment within a month of discharge for evaluation and connection to other agency services if applicable. Some of these services may include outpatient counseling for behavioral and emotional problems, psychiatric services, group therapy, case management, rehabilitation services, homeless recovery services, employment services, medication-assisted treatment, group-based team building activities, primary care clinic, and forensic services. Individuals may also receive ancillary referrals for applicable healthcare services, access to residential and outpatient substance abuse treatment services, and access to a tablet.

Locations

Country	Name	City	State
United States	Institute for Justice Research and Development	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in law breaking behavior	Change in law breaking behavior is tracked by a dichotomous "yes" or "no" survey in which participants are asked about law breaking behavior including if they had contact with police, if they participated in an activity that would have resulted in legal consequence had they been caught, or if they failed to pay child support.	2 weeks post-release
Other	Change in law breaking behavior	Change in law breaking behavior is tracked by a dichotomous "yes" or "no" survey in which participants are asked about law breaking behavior including if they had contact with police, if they participated in an activity that would have resulted in legal consequence had they been caught, or if they failed to pay child support.	3 months post-release
Other	Change in law breaking behavior	Change in law breaking behavior is tracked by a dichotomous "yes" or "no" survey in which participants are asked about law breaking behavior including if they had contact with police, if they participated in an activity that would have resulted in legal consequence had they been caught, or if they failed to pay child support.	6 months post-release
Other	Change in financial stability	Financial stability was defined as an ability to pay for one's bills, basic needs, and a potential unexpected expense without difficultly. Various intensity scales (0 = none/never to 5 = all of the time) and dichotomous "yes" "no" questions on an 8 question survey capture the participant's financial stability. The lower the score the greater the financial stability.	2 weeks post-release
Other	Change in financial stability	Financial stability was defined as an ability to pay for one's bills, basic needs, and a potential unexpected expense without difficultly. Various intensity scales (0 = none/never to 5 = all of the time) and dichotomous "yes" "no" questions on an 8 question survey capture the participant's financial stability.The lower the score the greater the financial stability.	3 months post-release
Other	Change in financial stability	Financial stability was defined as an ability to pay for one's bills, basic needs, and a potential unexpected expense without difficultly. Various intensity scales (0 = none/never to 5 = all of the time) and dichotomous "yes" "no" questions on an 8 question survey capture the participant's financial stability.The lower the score the greater the financial stability.	6 months post-release
Other	Change in perception of social support	Perception of social support was defined as the number of socially supportive characteristics (such as being someone they count on, are emotionally close with, can be themselves with, feel relaxed around, and feel valued by) present in 3 people in the participant's "social network." Participants are asked an identical set of 23 questions about these 3 people to capture their perception of the presence of socially supportive characteristics. Various intensity scales are used where (0= the least perception or never to 5 = the most perception of support or always). Dichotomous 'yes" and "no" questions are also used to capture participant's perception of the social support characteristics within their social network. The higher the score the greater the perception of social support.	2 weeks post release
Other	Change in perception of social support	Perception of social support was defined as the number of socially supportive characteristics (such as being someone they count on, are emotionally close with, can be themselves with, feel relaxed around, and feel valued by) present in 3 people in the participant's "social network." Participants are asked an identical set of 23 questions about these 3 people to capture their perception of the presence of socially supportive characteristics. Various intensity scales are used where (0= the least perception or never to 5 = the most perception of support or always). Dichotomous 'yes" and "no" questions are also used to capture participant's perception of the social support characteristics within their social network. The higher the score the greater the perception of social support.	3 months post release
Other	Change in perception of social support	Perception of social support was defined as the number of socially supportive characteristics (such as being someone they count on, are emotionally close with, can be themselves with, feel relaxed around, and feel valued by) present in 3 people in the participant's "social network." Participants are asked an identical set of 23 questions about these 3 people to capture their perception of the presence of socially supportive characteristics. Various intensity scales are used where (0= the least perception or never to 5 = the most perception of support or always). Dichotomous 'yes" and "no" questions are also used to capture participant's perception of the social support characteristics within their social network.The higher the score the greater the perception of social support.	6 months post release
Other	Change in psychological well-being	Psychological well-being is a complex combination of various psychological and personality characteristics and may be marked by the absence of mental and emotional disturbances including feelings of hopelessness, loneliness, anxiety, paranoia, or fear. psychological well-being is measured by the Brief Symptom Inventory, 53 items with a 6 question sub-scale of psychological symptoms were a respondent characterizes the intensity of mental and emotional disturbances (0= "not at all" to 4 - "extremely"). The higher the score the less psychological well-being present.	2 weeks post release
Other	Change in psychological well-being	Psychological well-being is a complex combination fo various psychological and personality characteristics and may be marked by the absence of mental and emotional disturbances including feelings of hopelessness, loneliness, anxiety, paranoia, or fear. psychological well-being is measured by the Brief Symptom Inventory, 53 items with a 6 question sub-scale of psychological symptoms were a respondent characterizes the intensity of mental and emotional disturbances (0= "not at all" to 4 - "extremely"). The higher the score the less psychological well-being present.	3 months post release
Other	Change in psychological well-being	Psychological well-being is a complex combination of various psychological and personality characteristics and may be marked by the absence of mental and emotional disturbances including feelings of hopelessness, loneliness, anxiety, paranoia, or fear. psychological well-being is measured by the Brief Symptom Inventory, 53 items with a 6 question sub-scale of psychological symptoms were a respondent characterizes the intensity of mental and emotional disturbances (0= "not at all" to 4 - "extremely"). The higher the score the less psychological well-being present.	6 months post release
Other	Change in employment stability	Employment stability is captured with an 11-item questionnaire that uses a combination of dichotomous "yes" or "no" questions and open-ended short answer questions to assess employment stability. Employment stability is defined through employment status, employment duration, employment history, and sources of income.	2 weeks post release
Other	Change in employment stability	Employment stability is captured with an 11-item questionnaire that uses a combination of dichotomous "yes" or "no" questions and open-ended short answer questions to assess employment stability. Employment stability is defined through employment status, employment duration, employment history, and sources of income.	3 months post release
Other	Change in employment stability	Employment stability is captured with an 11-item questionnaire that uses a combination of dichotomous "yes" or "no" questions and open-ended short answer questions to assess employment stability. Employment stability is defined through employment status, employment duration, employment history, and sources of income.	6 months post release
Other	Change in coping self-efficacy	Self-efficacy is a cognitive mechanism based on expectation or beliefs about one's ability to perform actions necessary to produce a given effect. The 28 item Brief Cope index assess coping self-efficacy and confidence coping with stress using an intensity scale (1= "never" to 4 = "always"). The higher the score the greater the coping self-efficacy.	2 weeks post release
Other	Change in coping self-efficacy	Self-efficacy is a cognitive mechanism based on expectation or beliefs about one's ability to perform actions necessary to produce a given effect. The 28 item Brief Cope index assess coping self-efficacy and confidence coping with stress using an intensity scale (1= "never" to 4 = "always"). The higher the score the greater the coping self-efficacy.	3 months post release
Other	Change in coping self-efficacy	Self-efficacy is a cognitive mechanism based on expectation or beliefs about one's ability to perform actions necessary to produce a given effect. The 28 item Brief Cope index assess coping self-efficacy and confidence coping with stress using an intensity scale (1= "never" to 4 = "always"). The higher the score the greater the coping self-efficacy.	6 months post release
Other	Change in psychological trauma	Psychological trauma is identified as an emotionally painful, shocking, stressful, and sometimes life-threatening experience. The 25-item Trauma History Questionnaire assess the occurrence of psychological trauma over the lifetime with dichotomous "yes" or "no" questions, then respondents are asked to self-report the age they were at the time of the incident and frequency the trauma occurred.	2 weeks post release
Other	Change in psychological trauma	Psychological trauma is identified as an emotionally painful, shocking, stressful, and sometimes life-threatening experience. The 25-item Trauma History Questionnaire assess the occurrence of psychological trauma over the previous 3 months with dichotomous "yes" or "no" questions, then respondents are asked to self-report the age they were at the time of the incident and frequency the trauma occurred.	3 months post release
Other	Change in psychological trauma	Psychological trauma is identified as an emotionally painful, shocking, stressful, and sometimes life-threatening experience. The 25-item Trauma History Questionnaire assess the occurrence of psychological trauma over the previous 3 months with dichotomous "yes" or "no" questions, then respondents are asked to self-report the age they were at the time of the incident and frequency the trauma occurred.	6 months post release
Other	Change in therapeutic alliance	Therapeutic alliance is identified as a relationship factor in counseling that includes three dimensions: goal consensus between counselor and client, collaboration on counseling-related tasks, and emotional bonding. Therapeutic alliance is assessed by the California Group Psychotherapy Alliance Scale, with 24 items on an intensity scale with 1 indicating "not at all" and 7 indicating "very much so." The lower the score the greater the therapeutic alliance.	2 weeks post release
Other	Change in therapeutic alliance	Therapeutic alliance is identified as a relationship factor in counseling that includes three dimensions: goal consensus between counselor and client, collaboration on counseling-related tasks, and emotional bonding. Therapeutic alliance is assessed by the California Group Psychotherapy Alliance Scale, with 24 items on an intensity scale with 1 indicating "not at all" and 7 indicating "very much so." The lower the score the greater the therapeutic alliance.	3 months post release
Other	Change in therapeutic alliance	Therapeutic alliance is identified as a relationship factor in counseling that includes three dimensions: goal consensus between counselor and client, collaboration on counseling-related tasks, and emotional bonding. Therapeutic alliance is assessed by the California Group Psychotherapy Alliance Scale, with 24 items on an intensity scale with 1 indicating "not at all" and 7 indicating "very much so." The lower the score the greater the therapeutic alliance.	6 months post release
Other	Change in technology use	Technology use is a 4 item qualitative questionnaire that assess respondents frequency of use, likes, and dislikes, of recommended behavioral health mobile applications.	2 weeks post release
Other	Change in technology use	Technology use is a 4 item qualitative questionnaire that assess respondents frequency of use, likes, and dislikes, of recommended behavioral health mobile applications.	3 months post release
Other	Change in technology use	Technology use is a 4 item qualitative questionnaire that assess respondents frequency of use, likes, and dislikes, of recommended behavioral health mobile applications.	6 months post release
Other	Perception of police interaction	Police interaction is defined as any physical contact with police and is assessed with the Police Contact Interaction Survey, a 30-item questionnaire with various intensity scales ranging from 1-4 where 1 = less satisfied and 4 = more satisfied with the police interaction. The survey also includes dichotomous "yes" or "no" questions where respondents identify if the police officer did a certain action. Respondents are asked to consider the police interaction that resulted in them being brought to the CSU.	baseline
Other	Perception of police interaction	Police interaction is defined as any physical contact with police and is assessed with the Police Contact Interaction Survey, a 30-item questionnaire with various intensity scales ranging from 1-4 where 1 = less satisfied and 4 = more satisfied with the police interaction. The survey also includes dichotomous "yes" or "no" questions where respondents identify if the police officer did a certain action. Respondents are asked to consider any police interaction occurring within the last 2 weeks.	2 weeks post release
Other	Perception of police interaction	Police interaction is defined as any physical contact with police and is assessed with the Police Contact Interaction Survey, a 30-item questionnaire with various intensity scales ranging from 1-4 where 1 = less satisfied and 4 = more satisfied with the police interaction. The survey also includes dichotomous "yes" or "no" questions where respondents identify if the police officer did a certain action. Respondents are asked to consider any police interaction occurring within the last 3 months.	3 months post release
Other	Perception of police interaction	Police interaction is defined as any physical contact with police and is assessed with the Police Contact Interaction Survey, a 30-item questionnaire with various intensity scales ranging from 1-4 where 1 = less satisfied and 4 = more satisfied with the police interaction. The survey also includes dichotomous "yes" or "no" questions where respondents identify if the police officer did a certain action. Respondents are asked to consider any police interaction occurring within the last 3 months.	6 months post release
Other	Change in hope self-efficacy	Self-efficacy is a cognitive mechanism based on expectation or beliefs about one's ability to perform actions necessary to produce a given effect. The Hearth Hope Index assess hope self-efficacy and a respondent's outlook on life with a 12-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more hope.	2 weeks post release
Other	Change in hope self-efficacy	Self-efficacy is a cognitive mechanism based on expectation or beliefs about one's ability to perform actions necessary to produce a given effect. The Hearth Hope Index assess hope self-efficacy and a respondent's outlook on life with a 12-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more hope.	3 months post release
Other	Change in hope self-efficacy	Self-efficacy is a cognitive mechanism based on expectation or beliefs about one's ability to perform actions necessary to produce a given effect. The Hearth Hope Index assess hope self-efficacy and a respondent's outlook on life with a 12-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more hope.	6 months post release
Other	Change in employment aspiration	Employment aspiration was defined as a desire and willingness to adjust one's employment situation. The Employment Education Aspiration Satisfaction assess education aspiration with a 13-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more employment aspiration.	2 weeks post release
Other	Change in employment aspiration	Employment aspiration was defined as a desire and willingness to adjust one's employment situation. The Employment Education Aspiration Satisfaction assess education aspiration with a 13-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more employment aspiration.	3 months post release
Other	Change in employment aspiration	Employment aspiration was defined as a desire and willingness to adjust one's employment situation. The Employment Education Aspiration Satisfaction assess education aspiration with a 13-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more employment aspiration.	6 months post release
Other	Change in education aspiration	Education aspiration was defined as a desire and willingness to increase one's education. The Employment Education Aspiration Satisfaction assess education aspiration with a 13-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more education aspiration.	2 weeks post release
Other	Change in education aspiration	Education aspiration was defined as a desire and willingness to increase one's education. The Employment Education Aspiration Satisfaction assess education aspiration with a 13-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more education aspiration.	3 months post release
Other	Change in education aspiration	Education aspiration was defined as a desire and willingness to increase one's education. The Employment Education Aspiration Satisfaction assess education aspiration with a 13-item questionnaire where responses are rated on an intensity scale 1-4 (1= "strongly disagree" to 4= "strongly agree"). The higher the score the more education aspiration.	6 months post release
Other	Change in need for community services	Change in need for community services is tracked using a service assessment questionnaire that captures the perceived need and use of services in areas of cognitive, housing, relationships, health, education, job readiness, substance abuse, mental health, and life skills. The service assessment questionnaire include dichotomous "yes" "no" questions, a continuum where respondents report "how many times" they received a service, and asks participants why they could not receive a service they perceived themself as needing.	2 weeks post release
Other	Change in need for community services	Change in need for community services is tracked using a service assessment questionnaire that captures the perceived need and use of services in areas of cognitive, housing, relationships, health, education, job readiness, substance abuse, mental health, and life skills. The service assessment questionnaire include dichotomous "yes" "no" questions, a continuum where respondents report "how many times" they received a service, and asks participants why they could not receive a service they perceived themself as needing.	3 months post release
Other	Change in need for community services	Change in need for community services is tracked using a service assessment questionnaire that captures the perceived need and use of services in areas of cognitive, housing, relationships, health, education, job readiness, substance abuse, mental health, and life skills. The service assessment questionnaire include dichotomous "yes" "no" questions, a continuum where respondents report "how many times" they received a service, and asks participants why they could not receive a service they perceived themself as needing.	6 months post release
Primary	Number of participants recruited	Number of eligible participant who agree to participate out of total number of eligible participants	up to 6 months
Primary	Retention of participants	Retention of participants is tracked by the number of recruited participants who complete the intervention	up to 6 months
Primary	Number of intervention sessions completed	Number of intervention sessions completed is tracked by the number of sessions participants complete over 6 months	up to 6 months
Secondary	Change in arrest rates	Change in arrest rates will be tracked by the number of arrests participants incur over a 6-month period beginning at baseline	up to 6 months
Secondary	Frequency of acute service use	Frequency of acute service use is tracked by the number of acute services participants partake in over a 6-month period beginning at baseline	up to 6 months
Secondary	Frequency of long-term treatment use	Frequency of long-term treatment use if tracked by the number of long-term treatment services participants partake in over a 6-month period beginning at baseline	up to 6 months
Secondary	Admission into a crisis stabilization unit	Admission into a crisis stabilization unit is tracked by the number of times a participant is admitted into a crisis stabilization unit over a 6-month period beginning at baseline	up to 6 months
Secondary	Acceptability of intervention specific aftercare services	Acceptability of intervention specific aftercare services is assessed through qualitative interviews with mental health stakeholders and CSU staff	up to 12 months