FostrSpace App for Addiction

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand how an online digital health application (app) called FostrSpace can reduce substance use among youth (ages 13-20 years old) in foster care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the FostrSpace treatment for addiction?

Research shows that using mobile phone applications alongside standard addiction treatments can help reduce substance use. Many studies found that people who used these apps had better outcomes, such as reduced cravings and consumption, compared to those who did not use them. ^{1 2 3 4 5}

Is the FostrSpace App safe for use in humans?

The safety of digital therapeutics, like the FostrSpace App, has been evaluated in clinical trials for opioid use disorder, showing it can be safely used alongside other treatments. However, more research is needed to confirm its safety across different conditions and longer-term use. ^{2 6 7 8 9}

How is the FostrSpace treatment for addiction different from other treatments?

FostrSpace is unique because it likely involves a mobile app-based approach, similar to other treatments that use smartphone applications to provide cognitive training and support for addiction. These apps can offer engaging, gamified elements that help with decision-making and managing cravings, making them more accessible and potentially more effective when combined with standard treatments. ^{1 2 8 10 11}

Research Team

Marina Tolou-Shams, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for young individuals aged 13-20 who are in foster care and struggling with substance use, specifically addiction or prescription drug abuse. The study aims to help them through the use of a digital health application.

Inclusion Criteria

I am a CASA worker over 18, assigned to a youth aged 13-20.

Exclusion Criteria

I am a non-English speaker working with a youth nearing the end of CASA services.

Youth: Non-English speaking, within 3 months of ending with CASA services, cognitive impairment that precludes ability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

CASA volunteers attend ECHO trainings to facilitate FostrSpace app referrals

12 weeks

6 biweekly sessions (in-person or virtual)

App Utilization

Participants use the FostrSpace app to reduce substance use

8 weeks

Ongoing app usage

Follow-up

Participants are monitored for safety and effectiveness after app usage

8 weeks

2 visits (virtual)

Treatment Details

Interventions

• FostrSpace

Trial Overview The intervention being tested is an online app called FostrSpace, designed to support youth in foster care with substance use issues. Participants will attend informational sessions as part of the study.

Participant Groups

Group I: InfoOnly Experimental Treatment 1 Intervention

CASA volunteers will attend a one-time 30-60 minute co-occurring SU and trauma ECHO training.

Group II: InfoECHO Experimental Treatment 1 Intervention

CASA volunteers will attend a six 90-minute/biweekly co-occurring SU and trauma ECHO trainings.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Mobile phone applications, when used alongside standard addiction treatments, can enhance the effectiveness of these treatments by providing tools for information, monitoring, motivation, and relapse prevention.

Most studies reviewed indicated that patients using these applications experienced a greater reduction in substance consumption compared to those receiving standard treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile phone applications for addiction treatment]. Penzenstadler, L., Thorens, G., Bachmann, S.[2022]

A systematic review of 22 controlled trials found that mobile health applications targeting substance use disorders can effectively reduce substance use, with eight applications showing significant reductions in usage among participants.

Most applications focused on educating users about the risks of substance use and managing cravings, suggesting that addressing cravings is crucial for preventing relapse, although the studies were limited by short durations and variability in their designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inventory and Analysis of Controlled Trials of Mobile Phone Applications Targeting Substance Use Disorders: A Systematic Review. Bahadoor, R., Alexandre, JM., Fournet, L., et al.[2021]

The 'Quest' app, designed for relapse prevention in patients with alcohol dependence syndrome, received high usability (5.8 out of 7) and acceptability (65%) ratings from users, indicating it is user-friendly and well-received.

While both groups (those using the Quest app and those receiving standard treatment) showed a significant reduction in drinking days over three months, there was no notable difference in relapse rates or heavy drinking days between the two groups, suggesting the app's effectiveness needs further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. Sharma, AK., Shadakshari, D., Chand, P., et al.[2023]

Out of 1973 participants offered the Connections app for substance use disorder, 40% downloaded it, and those who used the app showed improvements in their addiction-related behaviors over time, as measured by the Brief Addiction Monitor (BAM).

Participants referred by justice-related agencies preferred telehealth support from social workers, while self-referred individuals benefited equally from using the app alone or with recovery support services, indicating that self-motivated users may gain more from digital therapeutic tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adoption and sustainability of digital therapeutics in justice systems: A pilot feasibility study. Wilde, JA., Zawislak, K., Sawyer-Morris, G., et al.[2023]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

The SIDEAL mobile app was well-accepted by 24 adult patients with alcohol dependence, showing high usage rates (80% of study days) and high satisfaction levels, particularly with its self-register and feedback features.

Participants experienced significant reductions in alcohol consumption over 6 weeks, with binge drinking days decreasing from an average of 25 to 5.8 and mean daily consumption dropping from 6.5 to 1.9 standard units, indicating the app's potential efficacy in managing alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. Barrio, P., Ortega, L., López, H., et al.[2018]

A quality assessment of 25 self-tracking smartphone applications for alcohol use revealed that 17 apps scored positively on usability and design, with most performing better than typical health apps, indicating a promising potential for user engagement.

Despite the overall positive design ratings, significant shortcomings were found in interactivity and content quality, highlighting the need for improvements in consumer information, app availability, and evidence-based content to enhance user experience and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Content Quality of Alcohol-Related German, French and Italian Self-Tracking Applications. Klingemann, H., Flückiger, M., Bongard, T., et al.[2021]

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

This pilot study aims to evaluate the effectiveness of smartphone-based, multi-domain cognitive training with gamified elements for patients with alcohol use disorder (AUD), involving 60 participants in a randomized controlled trial.

The study will also assess the acceptability and feasibility of this mHealth intervention, gathering patient feedback to improve the tool, which could enhance conventional AUD treatments by addressing cognitive deficits that contribute to relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain+ AlcoRecover: A Randomized Controlled Pilot-Study and Feasibility Study of Multiple-Domain Cognitive Training Using a Serious Gaming App for Treating Alcohol Use Disorders. Mistarz, N., Nielsen, AS., Andersen, K., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Mobile phone applications for addiction treatment]. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Inventory and Analysis of Controlled Trials of Mobile Phone Applications Targeting Substance Use Disorders: A Systematic Review. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The adoption and sustainability of digital therapeutics in justice systems: A pilot feasibility study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Design and Content Quality of Alcohol-Related German, French and Italian Self-Tracking Applications. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The training game SALIENCE for the therapy of alcohol use disorder. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Brain+ AlcoRecover: A Randomized Controlled Pilot-Study and Feasibility Study of Multiple-Domain Cognitive Training Using a Serious Gaming App for Treating Alcohol Use Disorders. [2021]