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

Primary Purpose

Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery support as usual
Smartphone assisted relapse prevention
Sponsored by
Chestnut Health Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use Disorders focused on measuring Young Adults, Relapse Prevention, Smartphone, Recovery Support

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Chestnut Health SystemsRecruiting
  • Chestnut Health SystemsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Recovery Support as Usual Control

Smartphone Addiction Recovery Coach (SARC) - Assisted Relapse Prevention

Arm Description

Participants in the control and experimental condition will have access to post treatment recovery support services as usual.

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.

Outcomes

Primary Outcome Measures

Change in GAIN's Substance Frequency Scale from baseline to 6 months (effect of providing the intervention)
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.

Secondary Outcome Measures

Change in GAIN's Substance Frequency Scale from 6 to 9 months (effect of withdrawing the intervention)
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.
Change in GAIN Substance Disorder Screener (SDScr) from baseline to 6 months
Count of 5 past 90 day substance use disorder symptoms (alpha=.90) from the GAIN-Q3
Change in GAIN Risk Behavior Screener (RBScr) from baseline to 6 months
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
Change in European Quality of Life 5 dimensions (EQ5D) from baseline to 6 months
Count of 6 quality of life items (alpha=.83) from the EQ5D
Change in Mental Health Continuum Short Form (MHC-SF) from baseline to 6 months
Count of 14 items related to mental wellness (alpha=.94) from the MHC-SF
Change in the days of school from baseline to 6 months
The days of being in school during the past quarter (test-retest rho=.88) from the GAIN-Q3
Duration of abstinence after a given EMA
The duration of abstinence is the time from each completed EMA to the next indication of use - measured in days.

Full Information

First Posted
September 27, 2017
Last Updated
August 3, 2023
Sponsor
Chestnut Health Systems
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1. Study Identification

Unique Protocol Identification Number
NCT03301012
Brief Title
Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment
Acronym
SARC-YA
Official Title
Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chestnut Health Systems

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
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Young Adults, Relapse Prevention, Smartphone, Recovery Support

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants in the control and experimental condition will have access to post treatment recovery support services as usual. Participants in the experimental condition will receive a smartphone, a calling/texting/data plan, and the SARC-A 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recovery Support as Usual Control
Arm Type
Active Comparator
Arm Description
Participants in the control and experimental condition will have access to post treatment recovery support services as usual.
Arm Title
Smartphone Addiction Recovery Coach (SARC) - Assisted Relapse Prevention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Recovery support as usual
Intervention Description
same as arm
Intervention Type
Other
Intervention Name(s)
Smartphone assisted relapse prevention
Other Intervention Name(s)
Relapse Prevention
Intervention Description
same as arm
Primary Outcome Measure Information:
Title
Change in GAIN's Substance Frequency Scale from baseline to 6 months (effect of providing the intervention)
Description
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.
Time Frame
6 month SFS minus baseline SFS
Secondary Outcome Measure Information:
Title
Change in GAIN's Substance Frequency Scale from 6 to 9 months (effect of withdrawing the intervention)
Description
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.
Time Frame
9 months SFS minus 6 month SFS
Title
Change in GAIN Substance Disorder Screener (SDScr) from baseline to 6 months
Description
Count of 5 past 90 day substance use disorder symptoms (alpha=.90) from the GAIN-Q3
Time Frame
6 month minus baseline
Title
Change in GAIN Risk Behavior Screener (RBScr) from baseline to 6 months
Description
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
Time Frame
6 month minus baseline
Title
Change in European Quality of Life 5 dimensions (EQ5D) from baseline to 6 months
Description
Count of 6 quality of life items (alpha=.83) from the EQ5D
Time Frame
6 month minus baseline
Title
Change in Mental Health Continuum Short Form (MHC-SF) from baseline to 6 months
Description
Count of 14 items related to mental wellness (alpha=.94) from the MHC-SF
Time Frame
6 month minus baseline
Title
Change in the days of school from baseline to 6 months
Description
The days of being in school during the past quarter (test-retest rho=.88) from the GAIN-Q3
Time Frame
6 month minus baseline
Title
Duration of abstinence after a given EMA
Description
The duration of abstinence is the time from each completed EMA to the next indication of use - measured in days.
Time Frame
Measured at 5 random times per day over 6 months in the experimental condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: discharge from an adolescent outpatient SUD treatment program to the community; substance use during the 90 days prior to treatment; aged 18 to 26 at the time of discharge; Exclusion Criteria: inability to read and communicate in English; does NOT reside or plan to stay in Chicago during the next 9 months;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael L Dennis
Phone
309-451-7801
Email
mdennis@chestnut.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christy K Scott
Phone
312-664-4324
Email
cscott@chestnut.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Dennis, Ph.D.
Organizational Affiliation
Chestnut Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chestnut Health Systems
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael L Dennis, Ph.D.
Phone
309-451-7801
Email
mdennis@chestnut.org
First Name & Middle Initial & Last Name & Degree
Kelli Wright
Phone
309-451-7855
Email
kwright@chestnut.org
First Name & Middle Initial & Last Name & Degree
Michael L Dennis, Ph.D.
Facility Name
Chestnut Health Systems
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christy K Scott, Ph.D.
Phone
312-664-4321
Email
cscott@chestnut.org
First Name & Middle Initial & Last Name & Degree
Belinda Willis, MA
Phone
3126644321
Email
bwillis@chestnut.org
First Name & Middle Initial & Last Name & Degree
Christy K Scott, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

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

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