- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03301012
Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment (SARC-YA)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael L Dennis
- Phone Number: 309-451-7801
- Email: mdennis@chestnut.org
Study Contact Backup
- Name: Christy K Scott
- Phone Number: 312-664-4324
- Email: cscott@chestnut.org
Study Locations
-
-
Illinois
-
Bloomington, Illinois, United States, 61701
- Recruiting
- Chestnut Health Systems
-
Contact:
- Michael L Dennis, Ph.D.
- Phone Number: 309-451-7801
- Email: mdennis@chestnut.org
-
Contact:
- Kelli Wright
- Phone Number: 309-451-7855
- Email: kwright@chestnut.org
-
Principal Investigator:
- Michael L Dennis, Ph.D.
-
Chicago, Illinois, United States, 60610
- Recruiting
- Chestnut Health Systems
-
Contact:
- Christy K Scott, Ph.D.
- Phone Number: 312-664-4321
- Email: cscott@chestnut.org
-
Contact:
- Belinda Willis, MA
- Phone Number: 3126644321
- Email: bwillis@chestnut.org
-
Principal Investigator:
- Christy K Scott, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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;
Study Plan
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:
|
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:
|
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
Sponsor
Investigators
- Principal Investigator: Michael L Dennis, Ph.D., Chestnut Health Systems
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA011323-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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