NCT03301012

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
3.1 years until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

3.6 years

First QC Date

September 27, 2017

Last Update Submit

August 29, 2024

Conditions

Keywords

Young AdultsRelapse PreventionSmartphoneRecovery Support

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in GAIN's Substance Frequency Scale from 6 to 9 months (effect of withdrawing the intervention)

    9 months SFS minus 6 month SFS

  • Change in GAIN Substance Disorder Screener (SDScr) from baseline to 6 months

    6 month minus baseline

  • Change in GAIN Risk Behavior Screener (RBScr) from baseline to 6 months

    6 month minus baseline

  • Change in European Quality of Life 5 dimensions (EQ5D) from baseline to 6 months

    6 month minus baseline

  • Change in Mental Health Continuum Short Form (MHC-SF) from baseline to 6 months

    6 month minus baseline

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: Recovery support as usualOther: 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.

Other: Smartphone assisted relapse prevention

Interventions

same as arm

Recovery Support as Usual Control

same as arm

Also known as: Relapse Prevention
Recovery Support as Usual ControlSmartphone Addiction Recovery Coach (SARC) - Assisted Relapse Prevention

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • inability to read and communicate in English;
  • does NOT reside or plan to stay in Chicago during the next 9 months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chestnut Health Systems

Bloomington, Illinois, 61701, United States

Location

Chestnut Health Systems

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Michael L Dennis, Ph.D.

    Chestnut Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Psychologist and GAIN Coordinating Center Director

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 4, 2017

Study Start

October 30, 2020

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Locations