Clinical trial NCT03301012: Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment
Official title: Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Young Adults
Relapse Prevention
Smartphone
Recovery Support
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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 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;

Primary outcomes:
measure: Change in GAIN's Substance Frequency Scale from baseline to 6 months (effect of providing the intervention)
timeFrame: 6 month SFS minus baseline SFS
Secondary outcomes:
measure: Change in GAIN's Substance Frequency Scale from 6 to 9 months (effect of withdrawing the intervention)
timeFrame: 9 months SFS minus 6 month SFS
measure: Change in GAIN Substance Disorder Screener (SDScr) from baseline to 6 months
timeFrame: 6 month minus baseline
measure: Change in GAIN Risk Behavior Screener (RBScr) from baseline to 6 months
timeFrame: 6 month minus baseline
measure: Change in European Quality of Life 5 dimensions (EQ5D) from baseline to 6 months
timeFrame: 6 month minus baseline
measure: Change in Mental Health Continuum Short Form (MHC-SF) from baseline to 6 months
timeFrame: 6 month minus baseline
measure: Change in the days of school from baseline to 6 months
timeFrame: 6 month minus baseline
measure: Duration of abstinence after a given EMA
timeFrame: Measured at 5 random times per day over 6 months in the experimental condition
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Chestnut Health Systems
state: Illinois
city: Chicago
country: United States
facility: Chestnut Health Systems
state: Illinois
Study officials:
affiliation: Chestnut Health Systems
name: Michael L Dennis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: