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Mobile Support to Improve Recovery and Treatment Court Outcomes

Primary Purpose

Substance Use

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TXS- Supportive Text Group
TAU- Treatment As Usual
Sponsored by
Live Inspired, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Use focused on measuring Text Messaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

To be eligible, participants must be

  1. Age >18;
  2. Newly enrolled in the drug court program [within 1 month];
  3. Own a mobile phone and use text messaging;
  4. have a phone plan that allows unlimited texting;
  5. Agree to participate in the study protocol and be available for all assessments through the final 30-day assessment; and
  6. Speak and read English.

Exclusion criteria:

We will exclude anyone who is not able to participate in the intervention or assessments (e.g., deaf, blind, or otherwise impaired and unable to participate in computerized assessment).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    TXS- Supportive Text Group

    TAU- Treatment As Usual Group

    Arm Description

    Participants randomized to this arm (TXS) of the study will receive care as usual within the Drug Treatment Court (DTC) system plus supportive daily text messages which will be delivered at specific times each day for 30 days and will be signed by the judge for their specific DTC. (TXS) Group receives text messages for drug treatment compliance.

    Participants randomized to the (TAU) arm of the study will continue to participate in court-ordered treatments as usual with no additional intervention. Participants will receive motivational text messages for 30-days.

    Outcomes

    Primary Outcome Measures

    Feasibility as measured by study completion
    Percent of participants completing all assessment.
    Acceptability as measured by rating of text messages
    Participant ratings of TXS messages for helpfulness and liking.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2018
    Last Updated
    September 11, 2018
    Sponsor
    Live Inspired, LLC
    Collaborators
    The Miriam Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03668444
    Brief Title
    Mobile Support to Improve Recovery and Treatment Court Outcomes
    Official Title
    Mobile Support to Improve Recovery and Treatment Court Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    April 30, 2019 (Anticipated)
    Study Completion Date
    September 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Live Inspired, LLC
    Collaborators
    The Miriam Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will fully develop and implement an interactive text messaging intervention system for individuals sentenced to DTC. Upon completion of programming and testing of messages the investigators will enroll 40 participants and randomize participant to a control condition (TAU Group) or the intervention condition (TXS Group). Assessments will occur at enrollment, and day 30 follow up.
    Detailed Description
    This study builds on pilot work in which Live Inspired LLC and research partners, have a history of collaboration in the development, revision, and evaluation of web-based and mobile phone technologies to promote behavior change. For this project the investigators will fully develop and implement an interactive text messaging intervention system for individuals sentenced to DTC who are entering the program, at which time participants are expected to begin addressing underlying issues related to their addiction, and during which time participants are highly vulnerable to relapse and noncompliance with mandated activities. Outcomes will include participation in and compliance with Court-mandated appointments, abstinence from drug use (measured by urine testing), participation in substance abuse treatment, participation in education/employment training programs, and participation in related programs and workshops as directed by the Court. Data will be collected directly from Court records using a database established by the participating courts for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use
    Keywords
    Text Messaging

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Control Trial
    Masking
    Outcomes Assessor
    Masking Description
    Assessors are blinded to conditions
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TXS- Supportive Text Group
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm (TXS) of the study will receive care as usual within the Drug Treatment Court (DTC) system plus supportive daily text messages which will be delivered at specific times each day for 30 days and will be signed by the judge for their specific DTC. (TXS) Group receives text messages for drug treatment compliance.
    Arm Title
    TAU- Treatment As Usual Group
    Arm Type
    Placebo Comparator
    Arm Description
    Participants randomized to the (TAU) arm of the study will continue to participate in court-ordered treatments as usual with no additional intervention. Participants will receive motivational text messages for 30-days.
    Intervention Type
    Behavioral
    Intervention Name(s)
    TXS- Supportive Text Group
    Other Intervention Name(s)
    Intervention
    Intervention Description
    TXS participants will receive one treatment supportive text message each day for 30 days.These messages will address three domains 1) Recovery oriented messages, 2) Avoiding relapse and sanctions,and 3) Commitment to family, community and the Drug Treatment Court program. After receiving each text message, participants will receive a second message asking them to reply with a rating of how helpful the original message was. Ratings will use a 5-point Likert scale,ranging from 1-not at all helpful to 5-extremely helpful. Participants will also be asked to describe, via text message, what they liked or did not like about the original message, and suggest a better message for those they did not like.
    Intervention Type
    Behavioral
    Intervention Name(s)
    TAU- Treatment As Usual
    Other Intervention Name(s)
    Control
    Intervention Description
    Participants randomized to the TAU arm of the study will continue to participate in court-ordered treatments as usual with no additional intervention. Participants will receive one motivational text message for the 30-days.
    Primary Outcome Measure Information:
    Title
    Feasibility as measured by study completion
    Description
    Percent of participants completing all assessment.
    Time Frame
    30 day
    Title
    Acceptability as measured by rating of text messages
    Description
    Participant ratings of TXS messages for helpfulness and liking.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: To be eligible, participants must be Age >18; Newly enrolled in the drug court program [within 1 month]; Own a mobile phone and use text messaging; have a phone plan that allows unlimited texting; Agree to participate in the study protocol and be available for all assessments through the final 30-day assessment; and Speak and read English. Exclusion criteria: We will exclude anyone who is not able to participate in the intervention or assessments (e.g., deaf, blind, or otherwise impaired and unable to participate in computerized assessment).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Foster, BS
    Phone
    612-402-8833
    Email
    rfos02@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristen Walaska, BS
    Phone
    401-640-2853
    Email
    kwalaska@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ernestine Jennings, PhD
    Organizational Affiliation
    The Miriam Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is not a plan to make IPD available.

    Learn more about this trial

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