Substance AbuseNCT04899934
Feasibility of Mobile and Technology Assisted Aftercare Services for Crisis Stabilization Units
A study testing mobile and technology assisted aftercare and Treatment as usual in people with Substance Abuse and Criminal Behavior, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse, Criminal Behavior, Mental Disorder
- What is being tested?
- mobile and technology assisted aftercare and Treatment as usual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2021to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Justice Research and Development
Tallahassee, Florida, 32310
About this study
Official title: Multi-Site Feasibility Evaluation of Crisis Stabilization Units Across Three Jurisdictions With High Opioid Use Disorders and a Proposed Follow-Up RCT
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.
Read the detailed 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.
- Conditions
- Substance Abuse, Criminal Behavior, Mental Disorder
- Being tested
- mobile and technology assisted aftercare, Treatment as usual
- Keywords
- crisis stabilization, psychological well-being, law enforcement, mental health treatment, substance use disorder treatment
- Medical subject headings
- Substance-Related Disorders, Criminal Behavior, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile and technology assisted aftercareBehavioural
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.
Treatment as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile and technology assisted aftercare | Experimental | participants randomized to this condition will receive up to 26 sessions with a community support specialist aftercare provider and 6 months of access to behavioral health mobile applications. Receives: Behavioral: mobile and technology assisted aftercare |
| Treatment as usual (TAU) | Active comparator | Participants randomized to this condition receive standard treatment services available to persons discharging from a CSU. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
Number of eligible participant who agree to participate out of total number of eligible participants
Measured: up to 6 months
Retention of participants
Retention of participants is tracked by the number of recruited participants who complete the intervention
Measured: up to 6 months
Number of intervention sessions completed
Number of intervention sessions completed is tracked by the number of sessions participants complete over 6 months
Measured: up to 6 months
Secondary outcomes (5)
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
Measured: up to 6 months
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
Measured: up to 6 months
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
Measured: up to 6 months
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
Measured: up to 6 months
Acceptability of intervention specific aftercare services
Acceptability of intervention specific aftercare services is assessed through qualitative interviews with mental health stakeholders and CSU staff
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start14 Apr 2021
- Primary completion31 Mar 2022
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 24 adults releasing to one of the three participating counties in Florida will be randomly assigned to participate in the mobile and technology assisted aftercare or a treatment-as-usual (TAU) control group. Participants assigned to the treatment-as-usual control group will remain eligible to participate in all agency specific services offered to persons discharging the CSU as well as, any community resources they normally would have access to.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie Pettus-Davis, Florida State University
- Investigators
- Carrie Pettus, PHD, Principal investigator, Florida State University College of Social Work, Institute for Justice Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899934
- Sponsor's protocol ID
- STUDY00001570
- Other IDs
- 19-02811
- Status last verified
- Jun 2023
- First submitted
- 30 Apr 2021
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pettus C, Fulmer R, Pederson SD, Eikenberry J. Study protocol paper for the multi-site feasibility evaluation of mobile and technology-assisted aftercare services for crisis stabilization units. Pilot Feasibility Stud. 2023 Jul 31;9(1):135. doi: 10.1186/s40814-023-01361-8.
PubMed 37525253
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Site Feasibility Evaluation of Crisis Stabilization Units Across Three Jurisdictions With High Opioid Use Disorders and a Proposed Follow-Up RCT
- ClinicalTrials.gov ID
- NCT04899934
- Acronym / sponsor ID
- STUDY00001570
- Conditions
- Substance Abuse, Criminal Behavior, Mental Disorder
- Keywords
- crisis stabilization, psychological well-being, law enforcement, mental health treatment, substance use disorder treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 24 adults releasing to one of the three participating counties in Florida will be randomly assigned to participate in the mobile and technology assisted aftercare or a treatment-as-usual (TAU) control group. Participants assigned to the treatment-as-usual control group will remain eligible to participate in all agency specific services offered to persons discharging the CSU as well as, any community resources they normally would have access to.
| Arm | Type | Receives |
|---|---|---|
| Mobile and technology assisted aftercare | Experimental | Behavioral: mobile and technology assisted aftercareparticipants randomized to this condition will receive up to 26 sessions with a community support specialist aftercare provider and 6 months of access to behavioral health mobile applications. |
| Treatment as usual (TAU) | Active comparator | Other: Treatment as usualParticipants randomized to this condition receive standard treatment services available to persons discharging from a CSU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile and technology assisted aftercareThe 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. | Behavioural | Mobile and technology assisted aftercare |
| Treatment as usualTreatment 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. | Other | Treatment as usual (TAU) |
Primary outcome
Number of participants recruited
Time frame: up to 6 months
Number of eligible participant who agree to participate out of total number of eligible participants
Retention of participants
Time frame: up to 6 months
Retention of participants is tracked by the number of recruited participants who complete the intervention
Number of intervention sessions completed
Time frame: up to 6 months
Number of intervention sessions completed is tracked by the number of sessions participants complete over 6 months
5 secondary outcomes
Change in arrest rates
Time frame: up to 6 months
Frequency of acute service use
Time frame: up to 6 months
Frequency of long-term treatment use
Time frame: up to 6 months
Admission into a crisis stabilization unit
Time frame: up to 6 months
Acceptability of intervention specific aftercare services
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 37525253Pettus C, Fulmer R, Pederson SD, Eikenberry J. Study protocol paper for the multi-site feasibility evaluation of mobile and technology-assisted aftercare services for crisis stabilization units. Pilot Feasibility Stud. 2023 Jul 31;9(1):135. doi: 10.1186/s40814-023-01361-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Pettus, PHD principal investigator
Florida State University College of Social Work, Institute for Justice Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile and technology assisted aftercare and Treatment as usual in people with Substance Abuse and Criminal Behavior, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04899934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.