Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment (SARC-YA)

February 6, 2024 updated by: Michael L. Dennis, Ph.D., Chestnut Health Systems

At discharge from outpatient treatment, researchers will recruit 300 young adults and randomly assign them to recovery support as usual control condition or the Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) experimental condition. Participants in the experimental conditions will receive a smartphone, a calling/texting/data plan, and the SARC-YA mobile applications for the first 6 months post treatment discharge. Experimental participants will 1) complete a 2-3 minute recovery-focused ecological momentary assessment (EMA) at 5 random times a day, receive feedback on their current answers, and provided access to behavioral charting of their past answers over time; and 2) receive continuous access to a suite of self-initiated ecological momentary interventions (EMI) to support their recovery via tool box of coping tools, apps related to getting support, and apps related to maintaining a healthy lifestyle. Data include standardized assessments, urine tests, mobile phone metadata, EMA responses, and EMI utilization. The study's primary aim and hypothesis are:

Aim 1: Test the effects of experimental assignment on the frequency of substance use.

H1 Relative to the control group, participants in the experimental group will have lower scores on the quarterly Substance Frequency Scale (3, 6, 9 months post- discharge).

Study Overview

Detailed Description

At discharge from outpatient treatment, researchers will recruit 300 young adults and randomly assign them to recovery support as usual control condition or the Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) experimental condition. Participants in the experimental conditions will receive a smartphone, a calling/texting/data plan, and the SARC-YA mobile applications for the first 6 months post treatment discharge. Experimental participants will 1) complete a 2-3 minute recovery-focused ecological momentary assessment (EMA) at 5 random times a day, receive feedback on their current answers, and provided access to behavioral charting of their past answers over time; and 2) receive continuous access to a suite of self-initiated ecological momentary interventions (EMI) to support their recovery via tool box of coping tools, apps related to getting support, and apps related to maintaining a healthy lifestyle. Data include standardized assessments, urine tests, mobile phone metadata, EMA responses, and EMI utilization. The study's aims and their associated hypotheses are:

Aim 1: Test the effects of experimental assignment on the frequency of substance use.

H1 Relative to the control group, participants in the experimental group will have lower scores on the quarterly Substance Frequency Scale (3, 6, 9 months post- discharge). Aim 2: Evaluate the extent to which the experimental effects are moderated by baseline substance use frequency. H2 The Substance Frequency Scale Scores at intake will moderate the effects of experimental on the quarterly subsequent Substance Frequency Scale scores. Aim 3: Test the extent to which the frequency of substance use mediates the effects of experimental assignment on other aspects of recovery including SUD symptoms, HIV risk behavior, quality of life, mental wellness, and days of school. H3a Relative to the control group, participants in the experimental group will have better scores on other aspects of recovery (reverse of number of SUD symptoms, reverse of HIV risk behaviors, quality of life, mental wellness, days of school) in the quarterly interviews. H3b Higher Substance Frequency Scale scores (regardless of assignment) in a given quarter will be associated with worse scores on other aspects of recovery in the next quarter. H3c Substance Frequency Scale scores in a given quarter will mediate the impact of the experimental assignment on other aspects of recovery in the next quarter. Aim 4: Within the experimental condition, determine the degree to which EMA responses (e.g., use, withdrawal, craving, negative and positive affect) and EMI utilization predict the duration of abstinence (to be done within experimental condition.) H4a The duration of abstinence will be negatively related to EMA measures of the recency of use, withdrawal, craving, low self-efficacy to resist relapse, increased negative affect, and decreased positive affect. H4b The duration of abstinence will be positively related to immediate and cumulative EMI utilization.

Study Type

Interventional

Enrollment (Estimated)

300

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

Study Contact Backup

Study Locations

    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Recruiting
        • Chestnut Health Systems
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael L Dennis, Ph.D.
      • Chicago, Illinois, United States, 60610
        • Recruiting
        • Chestnut Health Systems
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christy K Scott, Ph.D.

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

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. discharge from an adolescent outpatient SUD treatment program to the community;
  2. substance use during the 90 days prior to treatment;
  3. aged 18 to 26 at the time of discharge;

    Exclusion Criteria:

  4. inability to read and communicate in English;
  5. does NOT reside or plan to stay in Chicago during the next 9 months;

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Recovery Support as Usual Control
Participants in the control and experimental condition will have access to post treatment recovery support services as usual.
same as arm
same as arm
Other Names:
  • Relapse Prevention
Experimental: Smartphone Addiction Recovery Coach (SARC) - Assisted Relapse Prevention
Participants in the experimental condition will receive a smartphone, a calling/texting/data plan, and the SARC-YA mobile applications for the first 6 months post treatment discharge. Experimental participants will 1) complete a 2-3 minute recovery-focused ecological momentary assessment (EMA) at 5 random times a day, receive feedback on their current answers, and provided access to behavioral charting of their past answers over time; and 2) receive continuous access to a suite of self-initiated ecological momentary interventions (EMI) to support their recovery via tool box of coping tools, apps related to getting support, and apps related to maintaining a healthy lifestyle.
same as arm
Other Names:
  • Relapse Prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GAIN's Substance Frequency Scale from baseline to 6 months (effect of providing the intervention)
Time Frame: 6 month SFS minus baseline SFS
The GAIN's Substance Frequency Scale (SFS; alpha=.85; test-retest rho=.94) ranges from 0 to 100% and is calculated as the average percent of days in the past 90 that adolescents reported alcohol, cannabis, stimulates, opioids, and other substance use, days of heavy substance use, and days of problems from substance use. Thus it incorporates the frequency of use, range of substances used, amount used, and degree to which use is causing problems.
6 month SFS minus baseline SFS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GAIN's Substance Frequency Scale from 6 to 9 months (effect of withdrawing the intervention)
Time Frame: 9 months SFS minus 6 month SFS
The GAIN's Substance Frequency Scale (SFS; alpha=.85; test-retest rho=.94) ranges from 0 to 100% and is calculated as the average percent of days in the past 90 that adolescents reported alcohol, cannabis, stimulates, opioids, and other substance use, days of heavy substance use, and days of problems from substance use. Thus it incorporates the frequency of use, range of substances used, amount used, and degree to which use is causing problems.
9 months SFS minus 6 month SFS
Change in GAIN Substance Disorder Screener (SDScr) from baseline to 6 months
Time Frame: 6 month minus baseline
Count of 5 past 90 day substance use disorder symptoms (alpha=.90) from the GAIN-Q3
6 month minus baseline
Change in GAIN Risk Behavior Screener (RBScr) from baseline to 6 months
Time Frame: 6 month minus baseline
Count of 6 past 90 day of HIV risk behaviors (test-retest rho=.80) including needle use, needle sharing, unprotected sex, multiple sexual partners, trading sex, and victimization from the GAIN-Q3
6 month minus baseline
Change in European Quality of Life 5 dimensions (EQ5D) from baseline to 6 months
Time Frame: 6 month minus baseline
Count of 6 quality of life items (alpha=.83) from the EQ5D
6 month minus baseline
Change in Mental Health Continuum Short Form (MHC-SF) from baseline to 6 months
Time Frame: 6 month minus baseline
Count of 14 items related to mental wellness (alpha=.94) from the MHC-SF
6 month minus baseline
Change in the days of school from baseline to 6 months
Time Frame: 6 month minus baseline
The days of being in school during the past quarter (test-retest rho=.88) from the GAIN-Q3
6 month minus baseline
Duration of abstinence after a given EMA
Time Frame: Measured at 5 random times per day over 6 months in the experimental condition
The duration of abstinence is the time from each completed EMA to the next indication of use - measured in days.
Measured at 5 random times per day over 6 months in the experimental condition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael L Dennis, Ph.D., Chestnut Health Systems

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)

October 30, 2020

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We use standardized measures and have a history of established relationships with several investigators who have had their own funds to conduct secondary analyses or need very limited support and are open to others. For EMA/EMI data from the pilot (and for this study, if funded) we are explicitly collaborating with Dr. Susan Murphy at the University of Michigan in her efforts to develop and evaluate Machine Learning algorithms on how to increase EMI utilization and prevent relapse even more effectively. Our data sharing practices have and will continue to include a mixture of publishing traditional peer-reviewed publications; making forms, reports, and normative tables available via the internet (or by request); providing analytic runs upon request; collaborating with other researchers; and providing copies of the de-identified data sets to eligible researchers. The later require data sharing agreements and commitments not to attempt re-identification.

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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