- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03668444
Mobile Support to Improve Recovery and Treatment Court Outcomes
September 11, 2018 updated by: Live Inspired, LLC
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility as measured by study completion
Time Frame: 30 day
|
Percent of participants completing all assessment.
|
30 day
|
|
Acceptability as measured by rating of text messages
Time Frame: 30 days
|
Participant ratings of TXS messages for helpfulness and liking.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ernestine Jennings, PhD, The Miriam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2018
Primary Completion (ANTICIPATED)
April 30, 2019
Study Completion (ANTICIPATED)
September 30, 2019
Study Registration Dates
First Submitted
September 11, 2018
First Submitted That Met QC Criteria
September 11, 2018
First Posted (ACTUAL)
September 12, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 13, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Grant # 1 R41 DA046268-01A1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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