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Mobile Support to Improve Recovery and Treatment Court Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668444
Recruitment Status : Unknown
Verified September 2018 by Live Inspired, LLC.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
The Miriam Hospital
Information provided by (Responsible Party):
Live Inspired, LLC

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.

Condition or disease Intervention/treatment Phase
Substance Use Behavioral: TXS- Supportive Text Group Behavioral: TAU- Treatment As Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial
Masking: Single (Outcomes Assessor)
Masking Description: Assessors are blinded to conditions
Primary Purpose: Supportive Care
Official Title: Mobile Support to Improve Recovery and Treatment Court Outcomes
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: TXS- Supportive Text Group
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.
Behavioral: TXS- Supportive Text Group
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.
Other Name: Intervention

Placebo Comparator: TAU- Treatment As Usual Group
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.
Behavioral: TAU- Treatment As Usual
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.
Other Name: Control




Primary Outcome Measures :
  1. Feasibility as measured by study completion [ Time Frame: 30 day ]
    Percent of participants completing all assessment.

  2. Acceptability as measured by rating of text messages [ Time Frame: 30 days ]
    Participant ratings of TXS messages for helpfulness and liking.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668444


Contacts
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Contact: Robert Foster, BS 612-402-8833 rfos02@gmail.com
Contact: Kristen Walaska, BS 401-640-2853 kwalaska@gmail.com

Sponsors and Collaborators
Live Inspired, LLC
The Miriam Hospital
Investigators
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Principal Investigator: Ernestine Jennings, PhD The Miriam Hospital
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Responsible Party: Live Inspired, LLC
ClinicalTrials.gov Identifier: NCT03668444    
Other Study ID Numbers: Grant # 1 R41 DA046268-01A1
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Live Inspired, LLC:
Text Messaging