Substance Use DisordersSARC-YANCT03301012
Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment
A study testing Recovery support as usual and Smartphone assisted relapse prevention in people with Substance Use Disorders, run by Chestnut Health Systems at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Recovery support as usual and Smartphone assisted relapse prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- inability to read and communicate in English;
- does NOT reside or plan to stay in Chicago during the next 9 months;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chestnut Health Systems
Bloomington, Illinois, 61701
Chestnut Health Systems
Chicago, Illinois, 60610
About this study
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).
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Recovery support as usual, Smartphone assisted relapse prevention
- Keywords
- Young Adults, Relapse Prevention, Smartphone, Recovery Support
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery support as usualOther
same as arm
Smartphone assisted relapse preventionOther
Also called Relapse Prevention
same as arm
| Study group | Role | What they receive |
|---|---|---|
| Recovery Support as Usual Control | Active comparator | Participants in the control and experimental condition will have access to post treatment recovery support services as usual. Receives: Other: Recovery support as usual; Other: Smartphone assisted relapse prevention |
| Smartphone Addiction Recovery Coach (SARC) - Assisted Relapse Prevention | Experimental | 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. Receives: Other: Smartphone assisted relapse prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month SFS minus baseline SFS
Secondary outcomes (7)
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.
Measured: 9 months SFS minus 6 month SFS
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
Measured: 6 month minus baseline
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
Measured: 6 month minus baseline
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
Measured: 6 month minus baseline
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
Measured: 6 month minus baseline
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
Measured: 6 month minus baseline
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.
Measured: Measured at 5 random times per day over 6 months in the experimental condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start30 Oct 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael L. Dennis, Ph.D., Chestnut Health Systems
- Investigators
- Michael L Dennis, Ph.D., Principal investigator, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301012
- Sponsor's protocol ID
- DA011323-15
- Acronym
- SARC-YA
- Status last verified
- Aug 2024
- First submitted
- 27 Sep 2017
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment
- ClinicalTrials.gov ID
- NCT03301012
- Acronym / sponsor ID
- SARC-YA / DA011323-15
- Conditions
- Substance Use Disorders
- Keywords
- Young Adults, Relapse Prevention, Smartphone, Recovery Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Recovery Support as Usual Control | Active comparator | Other: Recovery support as usual, Other: Smartphone assisted relapse preventionParticipants in the control and experimental condition will have access to post treatment recovery support services as usual. |
| Smartphone Addiction Recovery Coach (SARC) - Assisted Relapse Prevention | Experimental | Other: Smartphone assisted relapse preventionParticipants 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (2 listed)
- inability to read and communicate in English;
- does NOT reside or plan to stay in Chicago during the next 9 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery support as usualsame as arm | Other | Recovery Support as Usual Control |
| Smartphone assisted relapse preventionAlso: Relapse Preventionsame as arm | Other | Recovery Support as Usual Control, Smartphone Addiction Recovery Coach (SARC) - Assisted Relapse Prevention |
Primary outcome
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.
7 secondary outcomes
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
Change in GAIN Substance Disorder Screener (SDScr) from baseline to 6 months
Time frame: 6 month minus baseline
Change in GAIN Risk Behavior Screener (RBScr) from baseline to 6 months
Time frame: 6 month minus baseline
Change in European Quality of Life 5 dimensions (EQ5D) from baseline to 6 months
Time frame: 6 month minus baseline
Change in Mental Health Continuum Short Form (MHC-SF) from baseline to 6 months
Time frame: 6 month minus baseline
Change in the days of school from baseline to 6 months
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Dennis, Ph.D. principal investigator
Chestnut Health Systems
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery support as usual and Smartphone assisted relapse prevention in people with Substance Use Disorders, run by Chestnut Health Systems at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.