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Smartphone Addiction Recovery Coach for Adolescents (SARC-A) Experiment

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ClinicalTrials.gov Identifier: NCT03301012
Recruitment Status : Not yet recruiting
First Posted : October 4, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Dennis, Chestnut Health Systems

Brief Summary:

At discharge from outpatient treatment, researchers will recruit 300 adolescents and randomly assign them to recovery support as usual control condition or the Smartphone Addiction Recovery Coach for Adolescents (SARC-A) experimental condition. Participants in the experimental conditions 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. 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).


Condition or disease Intervention/treatment Phase
Substance Use Disorders Other: Recovery support as usual Other: Smartphone assisted relapse prevention Not Applicable

Detailed Description:

At discharge from outpatient treatment, researchers will recruit 300 adolescents and randomly assign them to recovery support as usual control condition or the Smartphone Addiction Recovery Coach for Adolescents (SARC-A) experimental condition. Participants in the experimental conditions 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. 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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Smartphone Addiction Recovery Coach for Adolescents (SARC-A) Experiment
Estimated Study Start Date : May 5, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 31, 2022

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.
Other: Recovery support as usual
same as arm

Other: Smartphone assisted relapse prevention
same as arm
Other Name: Relapse Prevention

Experimental: Smartphone Assisted Relapse Prevention
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.
Other: Smartphone assisted relapse prevention
same as arm
Other Name: Relapse Prevention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 15 to 18 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; and
  6. unable to provide parental/guardian consent if under age 18.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301012


Contacts
Contact: Michael L Dennis 309-451-7801 mdennis@chestnut.org
Contact: Christy K Scott 312-664-4324 cscott@chestnut.org

Locations
United States, Illinois
Chestnut Health Systems Not yet recruiting
Bloomington, Illinois, United States, 61701
Contact: Michael L Dennis, Ph.D.    309-451-7801    mdennis@chestnut.org   
Contact: Kelli Wright    309-451-7855    kwright@chestnut.org   
Principal Investigator: Michael L Dennis, Ph.D.         
Chestnut Health Systems Not yet recruiting
Chicago, Illinois, United States, 60610
Contact: Christy K Scott, Ph.D.    312-664-4321    cscott@chestnut.org   
Contact: Belinda Willis, MA    3126644321    bwillis@chestnut.org   
Principal Investigator: Christy K Scott, Ph.D.         
Sponsors and Collaborators
Chestnut Health Systems
Investigators
Principal Investigator: Michael L Dennis, Ph.D. Chestnut Health Systems

Responsible Party: Michael Dennis, Senior Research Psychologist and GAIN Coordinating Center Director, Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT03301012     History of Changes
Other Study ID Numbers: DA011323-15
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Dennis, Chestnut Health Systems:
Adolescent
Relapse Prevention
Smartphone
Recovery Support

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders