- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446910
Using Technology to Reduce Youth Substance Use (TEXT2)
December 21, 2023 updated by: University of California, San Francisco
The research project will focus on conducting a trial of whether a tailored SMS text-messaging intervention is efficacious in improving justice-involved youths' substance use or dual diagnosis treatment attendance and engagement.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study will demonstrate how delivery of motivational/coaching messages to justice-involved youth and their caregivers will lead to greater youth substance use treatment attendance and engagement.
The study will start with identifying the feasibility and acceptability of the SMS text-messaging intervention with community-supervised justice-involved youth.
Then, the study will determine whether the tailored dyadic (youth and caregiver) SMS text-messaging intervention improves justice-involved youth substance use or dual diagnosis treatment attendance and engagement relative to standard of care (not receiving motivational/coaching messages).
Finally, the study will characterize patterns of key justice and behavioral health system-level factors that promote or hinder eventual adoption and sustainability of mHealth technology as a tool to improve treatment attendance for justice-involved youth.
Study Type
Interventional
Enrollment (Estimated)
162
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.
Study Contact
- Name: Evan Holloway, PhD
- Phone Number: 415-613-8490
- Email: Evan.Holloway@ucsf.edu
Study Contact Backup
- Name: Marina Tolou-Shams, PhD
- Phone Number: 628-206-2212
- Email: marina.tolou-shams@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94131
- Recruiting
- UCSF Zuckerberg San Francisco General Hospital
-
Contact:
- Marina Tolou-Shams, PhD
- Phone Number: 628-206-2212
- Email: marina.tolou-shams@ucsf.edu
-
-
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
11 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- English-speaking youth with willing adult caregiver
- Ages 13-18
- Justice-involved while living in the community
- Own a mobile phone or tablet
- Are willing to send and receive text messages
- Are referred to community-based substance use and/or mental health treatment
Exclusion Criteria:
-
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: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMS Text Messaging
SMS text messaging intervention for a period of 90 days to encourage attendance at community-based substance use or dual diagnosis treatment appointments through motivational messages.
|
SMS text messaging intervention for a period of 90 days to promote attendance at community-based substance use or dual diagnosis treatment appointments through motivational messages.
|
Active Comparator: Standard of Care Engagement Practices
Standard of care engagement practices, such as communicating with youth and caregivers, as needed, through texting but frequency of contact and content of messaging varies according to individual needs.
|
Standard of care engagement practices, such as communicating with youth and caregivers, as needed, through texting but frequency of contact and content of messaging varies according to individual needs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment session attendance
Time Frame: 30 days post baseline
|
Proportion of treatment sessions attended
|
30 days post baseline
|
Treatment session attendance
Time Frame: 60 days post baseline
|
Proportion of treatment sessions attended
|
60 days post baseline
|
Treatment session attendance
Time Frame: 90 days post baseline
|
Proportion of treatment sessions attended
|
90 days post baseline
|
Treatment session attendance
Time Frame: 120 days post baseline
|
Proportion of treatment sessions attended
|
120 days post baseline
|
Treatment session attendance
Time Frame: 180 days post baseline
|
Proportion of treatment sessions attended
|
180 days post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
First treatment session initiation
Time Frame: 120 days post baseline
|
Proportion who attended first treatment session, as scheduled
|
120 days post baseline
|
First treatment session initiation
Time Frame: 180 days post baseline
|
Proportion who attended first treatment session, as scheduled
|
180 days post baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol use
Time Frame: 90 days post baseline
|
The Adolescent Risk Behavior Assessment (ARBA) is used to assess quantity and frequency of previous (lifetime and past 90 days) alcohol use.
|
90 days post baseline
|
Alcohol use
Time Frame: 180 days post baseline
|
The Adolescent Risk Behavior Assessment (ARBA) is used to assess quantity and frequency of previous (lifetime and past 90 days) alcohol use.
|
180 days post baseline
|
Drug use
Time Frame: 90 days post baseline
|
The Adolescent Risk Behavior Assessment (ARBA) is used to assess quantity and frequency of previous (lifetime and past 90 days) cannabis and other drug use.
|
90 days post baseline
|
Drug use
Time Frame: 180 days post baseline
|
The Adolescent Risk Behavior Assessment (ARBA) is used to assess quantity and frequency of previous (lifetime and past 90 days) cannabis and other drug use.
|
180 days post baseline
|
Drug Use
Time Frame: 90 days post baseline
|
The Texas Christian University (TCU) Drug Screen with Opioid Supplement is used to gather detailed information about drug and opioid use.
|
90 days post baseline
|
Drug Use
Time Frame: 180 days post baseline
|
The Texas Christian University (TCU) Drug Screen with Opioid Supplement is used to gather detailed information about drug and opioid use.
|
180 days post baseline
|
Response rate to SMS messages
Time Frame: 30 days post baseline
|
Digital (mobile) health metrics
|
30 days post baseline
|
Response rate to SMS messages
Time Frame: 60 days post baseline
|
Digital (mobile) health metrics
|
60 days post baseline
|
Response rate to SMS messages
Time Frame: 90 days post baseline
|
Digital (mobile) health metrics
|
90 days post baseline
|
Psychiatric symptoms
Time Frame: 90 days post baseline
|
Global Appraisal of Individual Needs-Short Screener (GAIN-SS) is used to identify people with recent and lifetime internalizing and externalizing mental health disorders, substance use disorders and crime/violence problems.
GAIN-SS responses are given in terms of the recency of the problem described in the questions: 3 = past month; 2 = 2 to 12 months ago; 1 = 1+ years ago; 0 = never.
The number of past-month symptoms (number of 3s) is used as a measure of change; the number of past-year symptoms (number of 3s or 2s) is used to identify who is likely to have a current diagnosis; and the number of lifetime symptoms (number of 3s, 2s, or 1s) is used as a covariate measure of lifetime severity.
|
90 days post baseline
|
Psychiatric symptoms
Time Frame: 180 days post baseline
|
Global Appraisal of Individual Needs-Short Screener (GAIN-SS) is used to identify people with recent and lifetime internalizing and externalizing mental health disorders, substance use disorders and crime/violence problems.
GAIN-SS responses are given in terms of the recency of the problem described in the questions: 3 = past month; 2 = 2 to 12 months ago; 1 = 1+ years ago; 0 = never.
The number of past-month symptoms (number of 3s) is used as a measure of change; the number of past-year symptoms (number of 3s or 2s) is used to identify who is likely to have a current diagnosis; and the number of lifetime symptoms (number of 3s, 2s, or 1s) is used as a covariate measure of lifetime severity.
|
180 days post baseline
|
Therapeutic Alliance
Time Frame: 30 days post baseline
|
The Working Alliance Inventory (WAI) is used to assess youth's perception of therapeutic alliance (with treatment provider) over time.
Scores range from 12 to 84 with higher scores indicating greater perceived therapeutic alliance.
|
30 days post baseline
|
Therapeutic Alliance
Time Frame: 60 days post baseline
|
The Working Alliance Inventory (WAI) is used to assess youth's perception of therapeutic alliance (with treatment provider) over time.
Scores range from 12 to 84 with higher scores indicating greater perceived therapeutic alliance.
|
60 days post baseline
|
Therapeutic Alliance
Time Frame: 90 days post baseline
|
The Working Alliance Inventory (WAI) is used to assess youth's perception of therapeutic alliance (with treatment provider) over time.
Scores range from 12 to 84 with higher scores indicating greater perceived therapeutic alliance.
|
90 days post baseline
|
Therapeutic Alliance
Time Frame: 120 days post baseline
|
The Working Alliance Inventory (WAI) is used to assess youth's perception of therapeutic alliance (with treatment provider) over time.
Scores range from 12 to 84 with higher scores indicating greater perceived therapeutic alliance.
|
120 days post baseline
|
Therapeutic Alliance
Time Frame: 180 days post baseline
|
The Working Alliance Inventory (WAI) is used to assess youth's perception of therapeutic alliance (with treatment provider) over time.
Scores range from 12 to 84 with higher scores indicating greater perceived therapeutic alliance.
|
180 days post baseline
|
Treatment Motivation
Time Frame: 30 days post baseline
|
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
|
30 days post baseline
|
Treatment Motivation
Time Frame: 60 days post baseline
|
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
|
60 days post baseline
|
Treatment Motivation
Time Frame: 90 days post baseline
|
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
|
90 days post baseline
|
Treatment Motivation
Time Frame: 120 days post baseline
|
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
|
120 days post baseline
|
Treatment Motivation
Time Frame: 180 days post baseline
|
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
|
180 days post baseline
|
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Time Frame: 30 days post baseline
|
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
|
30 days post baseline
|
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Time Frame: 60 days post baseline
|
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
|
60 days post baseline
|
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Time Frame: 90 days post baseline
|
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
|
90 days post baseline
|
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Time Frame: 120 days post baseline
|
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
|
120 days post baseline
|
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Time Frame: 180 days post baseline
|
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
|
180 days post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marina Tolou-Shams, PhD, University of California, San Francisco
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 (Actual)
May 1, 2020
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
May 7, 2020
First Submitted That Met QC Criteria
June 22, 2020
First Posted (Actual)
June 25, 2020
Study Record Updates
Last Update Posted (Actual)
December 26, 2023
Last Update Submitted That Met QC Criteria
December 21, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1K24DA046569-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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