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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04446910
Other study ID # 1K24DA046569-01A1
Secondary ID 1K24DA046569-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date April 1, 2024

Study information

Verified date December 2023
Source University of California, San Francisco
Contact Marina Tolou-Shams, PhD
Phone 628-206-2212
Email marina.tolou-shams@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 162
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SMS Text Messaging
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.
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.

Locations

Country Name City State
United States UCSF Zuckerberg San Francisco General Hospital San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Alcohol use 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
Other Alcohol use 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
Other Drug use 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
Other Drug use 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
Other Drug Use 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
Other Drug Use 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
Other Response rate to SMS messages Digital (mobile) health metrics 30 days post baseline
Other Response rate to SMS messages Digital (mobile) health metrics 60 days post baseline
Other Response rate to SMS messages Digital (mobile) health metrics 90 days post baseline
Other Psychiatric symptoms 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
Other Psychiatric symptoms 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
Other Therapeutic Alliance 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
Other Therapeutic Alliance 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
Other Therapeutic Alliance 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
Other Therapeutic Alliance 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
Other Therapeutic Alliance 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
Other Treatment Motivation The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation. 30 days post baseline
Other Treatment Motivation The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation. 60 days post baseline
Other Treatment Motivation The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation. 90 days post baseline
Other Treatment Motivation The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation. 120 days post baseline
Other Treatment Motivation The Motivation for Youth's Treatment Scale (MYTS) is used to measure intrinsic treatment motivation. 180 days post baseline
Other Characteristics of Communication and Interaction with Probation Officers and Treatment Providers 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
Other Characteristics of Communication and Interaction with Probation Officers and Treatment Providers 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
Other Characteristics of Communication and Interaction with Probation Officers and Treatment Providers 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
Other Characteristics of Communication and Interaction with Probation Officers and Treatment Providers 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
Other Characteristics of Communication and Interaction with Probation Officers and Treatment Providers 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
Primary Treatment session attendance Proportion of treatment sessions attended 30 days post baseline
Primary Treatment session attendance Proportion of treatment sessions attended 60 days post baseline
Primary Treatment session attendance Proportion of treatment sessions attended 90 days post baseline
Primary Treatment session attendance Proportion of treatment sessions attended 120 days post baseline
Primary Treatment session attendance Proportion of treatment sessions attended 180 days post baseline
Secondary First treatment session initiation Proportion who attended first treatment session, as scheduled 120 days post baseline
Secondary First treatment session initiation Proportion who attended first treatment session, as scheduled 180 days post baseline
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