Using Technology to Reduce Youth Substance Use (TEXT2)
Primary Purpose
Drug Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMS Text Messaging
Standard of Care Engagement Practices
Sponsored by
About this trial
This is an interventional treatment trial for Drug Use focused on measuring Adolescent, Juvenile justice, text messaging, Substance use, mHealth
Eligibility Criteria
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:
-
Sites / Locations
- UCSF Zuckerberg San Francisco General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SMS Text Messaging
Standard of Care Engagement Practices
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Treatment session attendance
Proportion of treatment sessions attended
Treatment session attendance
Proportion of treatment sessions attended
Treatment session attendance
Proportion of treatment sessions attended
Treatment session attendance
Proportion of treatment sessions attended
Treatment session attendance
Proportion of treatment sessions attended
Secondary Outcome Measures
First treatment session initiation
Proportion who attended first treatment session, as scheduled
First treatment session initiation
Proportion who attended first treatment session, as scheduled
Full Information
NCT ID
NCT04446910
First Posted
May 7, 2020
Last Updated
August 15, 2022
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04446910
Brief Title
Using Technology to Reduce Youth Substance Use
Acronym
TEXT2
Official Title
Using Technology to Reduce Youth Substance Use
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use
Keywords
Adolescent, Juvenile justice, text messaging, Substance use, mHealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a hybrid 1 effectiveness-implementation design in which the investigators will test a theory-driven digital health (i.e., SMS text-messaging) treatment engagement intervention while also collecting data on the text messaging platform's potential implementation and adoption within juvenile justice and behavioral health settings.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMS Text Messaging
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care Engagement Practices
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMS Text Messaging
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Engagement Practices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment session attendance
Description
Proportion of treatment sessions attended
Time Frame
30 days post baseline
Title
Treatment session attendance
Description
Proportion of treatment sessions attended
Time Frame
60 days post baseline
Title
Treatment session attendance
Description
Proportion of treatment sessions attended
Time Frame
90 days post baseline
Title
Treatment session attendance
Description
Proportion of treatment sessions attended
Time Frame
120 days post baseline
Title
Treatment session attendance
Description
Proportion of treatment sessions attended
Time Frame
180 days post baseline
Secondary Outcome Measure Information:
Title
First treatment session initiation
Description
Proportion who attended first treatment session, as scheduled
Time Frame
120 days post baseline
Title
First treatment session initiation
Description
Proportion who attended first treatment session, as scheduled
Time Frame
180 days post baseline
Other Pre-specified Outcome Measures:
Title
Alcohol use
Description
The Adolescent Risk Behavior Assessment (ARBA) is used to assess quantity and frequency of previous (lifetime and past 90 days) alcohol use.
Time Frame
90 days post baseline
Title
Alcohol use
Description
The Adolescent Risk Behavior Assessment (ARBA) is used to assess quantity and frequency of previous (lifetime and past 90 days) alcohol use.
Time Frame
180 days post baseline
Title
Drug use
Description
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.
Time Frame
90 days post baseline
Title
Drug use
Description
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.
Time Frame
180 days post baseline
Title
Drug Use
Description
The Texas Christian University (TCU) Drug Screen with Opioid Supplement is used to gather detailed information about drug and opioid use.
Time Frame
90 days post baseline
Title
Drug Use
Description
The Texas Christian University (TCU) Drug Screen with Opioid Supplement is used to gather detailed information about drug and opioid use.
Time Frame
180 days post baseline
Title
Response rate to SMS messages
Description
Digital (mobile) health metrics
Time Frame
30 days post baseline
Title
Response rate to SMS messages
Description
Digital (mobile) health metrics
Time Frame
60 days post baseline
Title
Response rate to SMS messages
Description
Digital (mobile) health metrics
Time Frame
90 days post baseline
Title
Psychiatric symptoms
Description
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.
Time Frame
90 days post baseline
Title
Psychiatric symptoms
Description
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.
Time Frame
180 days post baseline
Title
Therapeutic Alliance
Description
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.
Time Frame
30 days post baseline
Title
Therapeutic Alliance
Description
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.
Time Frame
60 days post baseline
Title
Therapeutic Alliance
Description
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.
Time Frame
90 days post baseline
Title
Therapeutic Alliance
Description
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.
Time Frame
120 days post baseline
Title
Therapeutic Alliance
Description
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.
Time Frame
180 days post baseline
Title
Treatment Motivation
Description
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
Time Frame
30 days post baseline
Title
Treatment Motivation
Description
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
Time Frame
60 days post baseline
Title
Treatment Motivation
Description
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
Time Frame
90 days post baseline
Title
Treatment Motivation
Description
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
Time Frame
120 days post baseline
Title
Treatment Motivation
Description
The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation.
Time Frame
180 days post baseline
Title
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Description
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
Time Frame
30 days post baseline
Title
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Description
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
Time Frame
60 days post baseline
Title
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Description
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
Time Frame
90 days post baseline
Title
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Description
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
Time Frame
120 days post baseline
Title
Characteristics of Communication and Interaction with Probation Officers and Treatment Providers
Description
Questions on communication characteristics will identify the preferred modes and patterns of communication between caregivers/youth and probation officers/treatment providers.
Time Frame
180 days post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Tolou-Shams, PhD
Phone
628-206-2212
Email
marina.tolou-shams@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Evan Holloway, PhD
Phone
415-613-8490
Email
Evan.Holloway@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Tolou-Shams, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Tolou-Shams, PhD
Phone
628-206-2212
Email
marina.tolou-shams@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using Technology to Reduce Youth Substance Use
We'll reach out to this number within 24 hrs