NCT03132753

Brief Summary

The investigators seek to develop and assess the effectiveness of Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT), a community-driven recovery-oriented system of care for individuals recently released from prison. SUPPORT is modeled after Indiana Access to Recovery (ATR), a program that operated between October 2007 and December 2014. ATR, a national initiative funded by the Substance Abuse and Mental Health Services Administration (SAMHSA), provided comprehensive, flexible, recovery-oriented services for substance use disorder (SUD). The investigators' local evaluation of this program demonstrated significant improvement in a number of recovery-related outcomes (e.g., substance use, employment, income, involvement in the criminal justice system, and emotional well-being) for clients between intake and discharge. Additionally, qualitative findings from this evaluation demonstrated ATR was well liked among clients and providers. While Indiana ATR did serve a wider range of clients, the investigators have focused SUPPORT on returning inmates because (a) this was the largest group served by the program and (b) there is significant need for evidence-based SUD interventions for this population. The investigators' primary long-term goal is to establish an effective and scalable recovery-oriented system of care for SUD within the reentry population. The investigators will conduct a pilot test comparing SUPPORT clients to clients receiving usual treatment. The investigators will collect quantitative data for both groups at multiple time points to understand the intervention's impact on recovery capital and outcomes and will collect qualitative data from SUPPORT clients to better understand their program and post-discharge experiences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
19 days until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

2.3 years

First QC Date

April 24, 2017

Results QC Date

July 31, 2020

Last Update Submit

January 27, 2022

Conditions

Outcome Measures

Primary Outcomes (17)

  • Number of Participants Reporting Substance Use

    Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

    Baseline

  • Number of Participants Reporting Substance Use

    Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

    6 months

  • Number of Participants Reporting Substance Use

    Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

    12 months

  • Difference in the Number of Days That Participants Reported Substance Use

    Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

    Baseline- 6 months

  • Difference in the Number of Days That Participants Reported Substance Use

    Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

    6 months - 12 months

  • Difference in the Number of Days That Participants Reported Substance Use

    Using the Frequency of Drug Use scale, we measured self-reported use of alcohol, sedative, tranquilizers, painkillers, stimulants, marijuana, cocaine, crack, hallucinogens, inhalants, heroin, and prescription medications. Respondents are asked to indicate the number of days having used each listed drug within the past 30 days. The minimum value is 0, and the maximum value is 30.

    Baseline - 12 months

  • Difference in Readiness to Change

    Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness to change behaviors related to substance use, using a 5 point scale 1 (Strongly Disagree), 2 (Disagree), 3 (Undecided), 4 (Agree), 5 (Strongly Agree). This measure is best used to assess stages of change at baseline; subsequent changes might not be clinically relevant. Subscales: 1. Recognition: A higher score indicates acknowledgement of the problem, possible harm, desires change. (Range: 7-35) 2. Ambivalence: A higher score reflects openness to reflection on drug use. A lower score may mean they "know" their drug use is causing problems (high Recognition), or they "know" that they do not have drug use problems (low Recognition). Thus, a low Ambivalence score should be interpreted in relation to the Recognition score. (Range: 4-20) 3. Taking steps: A higher score means steps have been taken, and they may already be experiencing success. (Range: 8-40)

    Baseline - 6 months

  • Difference in Readiness to Change

    Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness to change behaviors related to substance use, using a 5 point scale 1 (Strongly Disagree), 2 (Disagree), 3 (Undecided), 4 (Agree), 5 (Strongly Agree). This measure is best used to assess stages of change at baseline; subsequent changes might not be clinically relevant. Subscales: 1. Recognition: A higher score indicates acknowledgement of the problem, possible harm, desires change. (Range: 7-35) 2. Ambivalence: A higher score reflects openness to reflection on drug use. A lower score may mean they "know" their drug use is causing problems (high Recognition), or they "know" that they do not have drug use problems (low Recognition). Thus, a low Ambivalence score should be interpreted in relation to the Recognition score. (Range: 4-20) 3. Taking steps: A higher score means steps have been taken, and they may already be experiencing success. (Range: 8-40)

    6 months - 12 months

  • Difference in Readiness to Change

    Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness to change behaviors related to substance use, using a 5 point scale 1 (Strongly Disagree), 2 (Disagree), 3 (Undecided), 4 (Agree), 5 (Strongly Agree). This measure is best used to assess stages of change at baseline; subsequent changes might not be clinically relevant. Subscales: 1. Recognition: A higher score indicates acknowledgement of the problem, possible harm, desires change. (Range: 7-35) 2. Ambivalence: A higher score reflects openness to reflection on drug use. A lower score may mean they "know" their drug use is causing problems (high Recognition), or they "know" that they do not have drug use problems (low Recognition). Thus, a low Ambivalence score should be interpreted in relation to the Recognition score. (Range: 4-20) 3. Taking steps: A higher score means steps have been taken, and they may already be experiencing success. (Range: 8-40)

    Baseline - 12 months

  • Difference in Quality of Life: Perceived General Health

    Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. One of the four items requests participants to report on their general health, with a scale of (1) excellent, (2) very good, (3) good, (4) fair, (5) poor.

    Baseline - 6 months

  • Difference in Quality of Life: Perceived General Health

    Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. One of the four items requests participants to report on their general health, with a scale of (1) excellent, (2) very good, (3) good, (4) fair, (5) poor.

    6 months - 12 months

  • Difference in Quality of Life: Perceived General Health

    Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. One of the four items requests participants to report on their general health, with a scale of (1) excellent, (2) very good, (3) good, (4) fair, (5) poor.

    Baseline - 12 months

  • Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health

    Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. Two of the four items requested the number of unhealthy days, physically or mentally, out of the past 30 days. These are reported as a sum. One of the four items requested the number of days that usual activities are prevented due to poor physical or mental health are also reported out of the past 30 days.

    Baseline - 6 months

  • Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health

    Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. Two of the four items requested the number of unhealthy days, physically or mentally, out of the past 30 days. These are reported as a sum. One of the four items requested the number of days that usual activities are prevented due to poor physical or mental health are also reported out of the past 30 days.

    6 months - 12 months

  • Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health

    Using the 4-item Current Quality of Life Scale, we measured an individual's perceived general physical and mental health during the past 30 days. Self-perception of current physical and mental health is indicative of a person's current health and future health outcomes. The general assessment of health has been shown to be both a solid measure of self-reported health and a powerful predictor of mortality and morbidity. Two of the four items requested the number of unhealthy days, physically or mentally, out of the past 30 days. These are reported as a sum. One of the four items requested the number of days that usual activities are prevented due to poor physical or mental health are also reported out of the past 30 days.

    Baseline - 12 months

  • Frequency of Incarceration

    Incarceration was measured through publicly available data on arrests, convictions, and periods of incarceration in Indiana. We searched each name in state prison and county jail records and identified them as incarcerated if their name appeared in the jail or prison data during the 12 month study window of their enrollment. Note: At baseline, we confirmed with our community partner that each participant had been in prison or jail, or on work release, within the past 3 months. However, this did not match the publicly available data, indicating that the available data is likely incomplete.

    6 months

  • Frequency of Incarceration

    Incarceration was measured through publicly available data on arrests, convictions, and periods of incarceration in Indiana. We searched each name in state prison and county jail records and identified them as incarcerated if their name appeared in the jail or prison data during the 12 month study window of their enrollment. Note: At baseline, we confirmed with our community partner that each participant had been in prison or jail, or on work release, within the past 3 months. However, this did not match the publicly available data, indicating that the available data is likely incomplete.

    12 months

Secondary Outcomes (24)

  • Difference in Self Determination

    Baseline - 6 months

  • Difference in Self Determination

    6 months - 12 months

  • Difference in Self Determination

    Baseline - 12 months

  • Difference in Self Efficacy

    Baseline - 6 months

  • Difference in Self Efficacy

    6 months - 12 months

  • +19 more secondary outcomes

Study Arms (2)

SUPPORT Group

EXPERIMENTAL

Subjects enrolled in the intervention.

Behavioral: SUPPORT

Treatment as Usual

NO INTERVENTION

Subjects enrolled in standard services.

Interventions

SUPPORTBEHAVIORAL

SUPPORT clients will be offered 12 months of support service with a recovery coach. The recovery coach will guide the client through their recovery, offering guidance and support, while coordinating their treatment services, including support services. The program will provide clients with up to $700 worth of vouchers to cover the cost of additional flexible support services over the 12 months of program enrollment, which will be personalized to fit the needs of the client. These cost vouchers will cover support services, such as housing, employment services, substance use treatment, transportation, childcare, educational or vocational services, or aftercare planning. The costs of each service is determined by the service provider. Further, the recovery coach will assist the client in choosing appropriate services and coordinating/monitoring service completion.

SUPPORT Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All PACE clients who are over the age of 18, have a SUD, are no longer incarcerated (in a prison, jail, or work release facility), are within 3 months of release from prison, jail, or work release, and are unable to access the previously mentioned Recovery Works program will be eligible for study participation.

You may not qualify if:

  • Any individual that is not a PACE client, has not been released from prison, over the age of 18, or does not have a substance abuse disorder will not be included in the study.
  • Also, sex offenders will be excluded from this study because of the additional integration barriers faced by this population and their increased parole supervision, as these may confounding variables in such a small pilot.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Advocates in Community Re-Entry (PACE)

Indianapolis, Indiana, 46218, United States

Location

Related Publications (1)

  • Watson DP, Ray B, Robison L, Xu H, Edwards R, Salyers MP, Hill J, Shue S. Developing Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT): protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2017 Dec 15;3:73. doi: 10.1186/s40814-017-0212-1. eCollection 2017.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

A limitation is that this is a pilot study for which formal hypothesis testing was not a goal. Retention was low.

Results Point of Contact

Title
Dennis Watson
Organization
Chestnut Health's Lighthouse Institute; Chicago, Illinois

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 28, 2017

Study Start

October 23, 2017

Primary Completion

January 30, 2020

Study Completion

September 30, 2020

Last Updated

February 3, 2022

Results First Posted

October 19, 2020

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations