Substance UseNCT03668444
Mobile Support to Improve Recovery and Treatment Court Outcomes
A study testing TXS- Supportive Text Group and TAU- Treatment As Usual in people with Substance Use, run by Live Inspired, LLC.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- TXS- Supportive Text Group and TAU- Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 30 Sep 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- TXS- Supportive Text Group, TAU- Treatment As Usual
- Keywords
- Text Messaging
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXS- Supportive Text GroupBehavioural
Also called Intervention
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.
TAU- Treatment As UsualBehavioural
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| TXS- Supportive Text Group | Experimental | 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. Receives: Behavioral: TXS- Supportive Text Group |
| TAU- Treatment As Usual Group | Placebo comparator | 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. Receives: Behavioral: TAU- Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by study completion
Percent of participants completing all assessment.
Measured: 30 day
Acceptability as measured by rating of text messages
Participant ratings of TXS messages for helpfulness and liking.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Live Inspired, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Miriam Hospital
- Responsible party
- Sponsor
- Investigators
- Ernestine Jennings, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668444
- Sponsor's protocol ID
- Grant # 1 R41 DA046268-01A1
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Support to Improve Recovery and Treatment Court Outcomes
- ClinicalTrials.gov ID
- NCT03668444
- Acronym / sponsor ID
- Grant # 1 R41 DA046268-01A1
- Conditions
- Substance Use
- Keywords
- Text Messaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Live Inspired, LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Miriam Hospital
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 12 Sep 2018 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| TXS- Supportive Text Group | Experimental | Behavioral: TXS- Supportive Text GroupParticipants 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. |
| TAU- Treatment As Usual Group | Placebo comparator | Behavioral: TAU- Treatment As UsualParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| TXS- Supportive Text GroupAlso: InterventionTXS 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. | Behavioural | TXS- Supportive Text Group |
| TAU- Treatment As UsualAlso: ControlParticipants 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. | Behavioural | TAU- Treatment As Usual Group |
Primary outcome
Feasibility as measured by study completion
Time frame: 30 day
Percent of participants completing all assessment.
Acceptability as measured by rating of text messages
Time frame: 30 days
Participant ratings of TXS messages for helpfulness and liking.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Ernestine Jennings, PhD principal investigator
The Miriam Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TXS- Supportive Text Group and TAU- Treatment As Usual in people with Substance Use, run by Live Inspired, LLC.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Foster, BS (612-402-8833, rfos02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by study completion (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2018.