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

Substance Use Disorders Clinical Trial

— SARC-YA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03301012
• Other study ID #: DA011323-15
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Chestnut Health Systems
• Contact: Michael L Dennis
• Phone: 309-451-7801
• Email: mdennis[@]chestnut.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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;

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Recovery support as usual
same as arm
• Smartphone assisted relapse prevention
same as arm

Locations

Country	Name	City	State
United States	Chestnut Health Systems	Bloomington	Illinois
United States	Chestnut Health Systems	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Chestnut Health Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month SFS minus baseline SFS
Secondary	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.	9 months SFS minus 6 month SFS
Secondary	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	6 month minus baseline
Secondary	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	6 month minus baseline
Secondary	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	6 month minus baseline
Secondary	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	6 month minus baseline
Secondary	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	6 month minus baseline
Secondary	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 at 5 random times per day over 6 months in the experimental condition