NCT03668444

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

September 11, 2018

Last Update Submit

September 11, 2018

Conditions

Keywords

Text Messaging

Outcome Measures

Primary Outcomes (2)

  • Feasibility as measured by study completion

    Percent of participants completing all assessment.

    30 day

  • Acceptability as measured by rating of text messages

    Participant ratings of TXS messages for helpfulness and liking.

    30 days

Study Arms (2)

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.

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.

Behavioral: TAU- Treatment As Usual

Interventions

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.

Also known as: Intervention
TXS- Supportive Text 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 one motivational text message for the 30-days.

Also known as: Control
TAU- Treatment As Usual Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ernestine Jennings, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Foster, BS

CONTACT

Kristen Walaska, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors are blinded to conditions
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 12, 2018

Study Start

October 1, 2018

Primary Completion

April 30, 2019

Study Completion

September 30, 2019

Last Updated

September 13, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.