Web-Based Interventions for Adolescent Substance Use and Behavioral Health

(ASPIRE Trial)

Overseen By Timothy J Ozechowski, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Research Institute

Disqualifiers: Psychotic state, Organic state, others

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

Compensation: Varies

Number of Visits: 3

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are: * Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC) * Are outcomes for ePACE are superior to those for eFACE * Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on web-based interventions for substance use and behavioral health, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment eFACE and ePACE for adolescent substance use and behavioral health?

Research shows that internet-based treatments can improve addiction care by making it easier to deliver information and track progress, which can help prevent relapse and support recovery. Personalized eHealth approaches have been effective in other areas, like weight management, suggesting that tailoring interventions to individual needs can enhance treatment outcomes. ^{1 2 3 4 5}

Is the web-based intervention for adolescent substance use and behavioral health safe?

The research suggests that digital therapeutics, including web-based interventions, are generally safe for use in behavioral health, as they provide a secure way to deliver treatment and collect data. However, specific safety data for the interventions named (eFACE, ePACE) is not detailed in the available studies. ^{1 5 6 7 8}

How is the eFACE and ePACE treatment different from other treatments for adolescent substance use?

The eFACE and ePACE treatments are unique because they are web-based interventions that use interactive technology to engage adolescents in behavior change, offering personalized feedback and ongoing support, which can be more accessible and engaging compared to traditional in-person therapy. ^{1 4 9 10 11}

Eligibility Criteria

This trial is for adolescents with mild to moderate substance use and related behavioral health issues. They should be willing to engage in web-based interventions and complete assessments over a 6-month period. Specific eligibility details are not provided, but typically participants must meet certain age and health criteria.

Inclusion Criteria

Sufficient English language skills for assessments and intervention

I am between 12 and 17 years old.

Reporting mild/moderate substance use

Exclusion Criteria

A sibling has already participated in the study

Evidence of psychotic or organic state

High problem severity indicating possible need for higher level of care

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in either the ePACE or eFACE intervention, which includes behavior change modules focused on substance use and co-occurring problems.

3 months

Baseline assessment, followed by intervention activities

Follow-up

Participants are monitored for changes in substance use and co-occurring problems, with assessments at 3 and 6 months.

6 months

Assessments at 3 months and 6 months

Waiting List Comparison

Participants in the waitlist group do not receive the intervention until after the 6-month assessment.

6 months

Treatment Details

Interventions

• eFACE
• ePACE

Trial Overview The study compares two web-based interventions: ePACE, which is personalized, allowing youth choice in content and engagement level; versus eFACE, a fixed intervention without personalization. Both aim to address drug abuse, interpersonal relations, negative emotions, and stress.

Participant Groups

Group I: ePACE Experimental Condition Experimental Treatment 1 Intervention

The experimental intervention to be administered, ePACE, is a web-based brief intervention that includes personalization and youth-centered features. Feedback is provided based on youth's responses to activities, exercises, and quizzes to guide each individual's behavior change efforts.

Group II: eFACE Active Comparator Condition Active Control 1 Intervention

The eFACE active comparator arm involves the eFACE intervention and includes content that is similar to the ePACE experimental intervention, but modules are offered in a fixed order with no tailoring features. No personalized feedback based on youth responses are provided to inform individual youth's behavior change efforts.

Group III: Waiting List Comparison Group Active Control 1 Intervention

Youth in the waitlist comparison (WC) condition will not have access to the ePACE or eFACE modules until the final (6-month) assessment has been completed. Thus, the WC group will serve as a "no intervention" comparison group.

Who Is Running the Clinical Trial?

Oregon Research Institute

Lead Sponsor

Trials

87

Recruited

62,600+

Findings from Research

The Internet can significantly enhance addiction treatment by enabling efficient delivery of educational content and secure collection of self-reported data on substance use, making treatment more accessible and effective.

Internet applications support various aspects of addiction treatment, including assessment, monitoring patient outcomes, ongoing recovery support, and training for treatment providers, ultimately improving the quality of care and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Internet technology can improve the quality of care for substance use disorders. Cucciare, MA., Weingardt, KR., Humphreys, K.[2019]

Personalized eHealth interventions significantly reduce body weight, with an average loss of 2.77 kg compared to control groups, based on a meta-analysis of 15 randomized controlled trials involving various durations, some with follow-ups up to 12 months.

Key features for effective personalized eHealth interventions include tailored content, customized feedback, human interaction, and strategies like goal setting and self-monitoring, suggesting that these elements should be prioritized in future designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised eHealth interventions in adults with overweight and obesity: A systematic review and meta-analysis of randomised controlled trials. Lau, Y., Chee, DGH., Chow, XP., et al.[2021]

Therapeutic Persuasiveness, which includes persuasive design and behavior change techniques, is the strongest predictor of user adherence to behavioral eHealth interventions, explaining 42% of the variance in adherence rates.

In a study analyzing 30 web-based interventions, those with higher Therapeutic Persuasiveness saw up to six times more users engaging with the interventions for longer periods, highlighting the critical role of effective design in promoting sustained use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting user adherence to behavioral eHealth interventions in the real world: examining which aspects of intervention design matter most. Baumel, A., Yom-Tov, E.[2019]

The e-therapeutic platform (Next.Step) was positively received by adolescents, showing satisfaction and effectiveness in promoting health behavior changes, despite only 54.17% of participants accessing it during the 24-week study.

Participants who engaged more with the platform showed significant improvements in health metrics, such as reduced body mass index and waist circumference, indicating that even limited use can lead to positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of an internet-based platform (Next.Step) for adolescent weight management. Sousa, P., Fonseca, H., Gaspar, P., et al.[2020]

The StayFine app-based intervention for young people in remission from anxiety or depression uses a personalized approach by integrating data from diagnostic interviews, self-report questionnaires, and individual symptom tracking, allowing participants to choose modules that best fit their needs.

Preliminary results indicate that the data-driven sources provide complementary advice for module selection, with a preference for positive-focused modules during shared decision-making, suggesting that personalization may enhance engagement and adherence in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Congruency of multimodal data-driven personalization with shared decision-making for StayFine: individualized app-based relapse prevention for anxiety and depression in young people. Kooiman, BEAM., Robberegt, SJ., Albers, CJ., et al.[2023]

The ORION tool, an innovative e-health psychoeducational software, was developed to inform opioid-dependent individuals about overdose risks and identified seven key risk factors related to their behaviors.

While the ORION tool did not significantly change self-efficacy scores in participants, it effectively identified those at higher risk, suggesting that it could be a valuable component of a broader intervention strategy when combined with other support methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study. Carrà, G., Crocamo, C., Humphris, G., et al.[2022]

Digital therapeutics provide accessible treatment options for substance use and mental health conditions through platforms like apps and video conferencing, breaking down barriers related to time and location.

Despite strong evidence supporting their effectiveness, the field of implementation science for scaling digital therapeutics in behavioral health is still developing, highlighting the need for further research and collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Workshop on Implementation Science and Digital Therapeutics for Behavioral Health. Lord, SE., Campbell, ANC., Brunette, MF., et al.[2023]

A study involving 166 adults with alcohol use disorder found that a therapist-guided high-intensity internet intervention did not significantly outperform an unguided low-intensity intervention in reducing alcohol consumption at the 6-month follow-up.

Both interventions had low rates of negative effects (8-14%) and deterioration (3-5%), indicating that they were relatively safe options for participants seeking help with alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial. Sundström, C., Eék, N., Kraepelien, M., et al.[2021]

The article discusses interactive, computer-based programs designed for substance abuse prevention and treatment among adolescents, highlighting their effectiveness in promoting health behavior changes.

These programs are based on scientific principles and utilize evidence-based technologies, making them engaging and suitable for widespread use, which can enhance their accessibility and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of interactive, computer technology to adolescent substance abuse prevention and treatment. Marsch, LA., Bickel, WK., Grabinski, MJ.[2008]

Experts identified key strategies for web-based computer-tailored interventions to reduce binge drinking among adolescents, including encouraging parental involvement and teaching refusal skills to teens.

To minimize drop-out rates from these interventions, experts suggested improving content relevance, using appropriate language, and implementing reminders and incentives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based interventions to decrease alcohol use in adolescents: a Delphi study about increasing effectiveness and reducing drop-out. Jander, A., Crutzen, R., Mercken, L., et al.[2018]

The online-based Brief Empowerment Program for Alcohol-Use Monitor (on-BEAM) significantly reduced alcohol consumption among participants, with a reported reduction in standard drinks consumed during the past week (RR = 0.13; p = 0.012) compared to the control group.

Participants in the on-BEAM intervention also showed a decrease in binge drinking rates (RR = 0.69; p < 0.001) and lower AUDIT-C scores (RR = 0.59; p = 0.009), indicating its efficacy in promoting healthier drinking behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Web-Based Screening and Brief Intervention to Prevent Problematic Alcohol Use in Korea: Results of a Randomized Controlled Trial. Jo, SJ., Lee, HK., Kang, K., et al.[2022]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

How Internet technology can improve the quality of care for substance use disorders. [2019]

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

Personalised eHealth interventions in adults with overweight and obesity: A systematic review and meta-analysis of randomised controlled trials. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Predicting user adherence to behavioral eHealth interventions in the real world: examining which aspects of intervention design matter most. [2019]

4. Brazil pubmed.ncbi.nlm.nih.gov

Usability of an internet-based platform (Next.Step) for adolescent weight management. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Congruency of multimodal data-driven personalization with shared decision-making for StayFine: individualized app-based relapse prevention for anxiety and depression in young people. [2023]

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

Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Workshop on Implementation Science and Digital Therapeutics for Behavioral Health. [2023]

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

High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial. [2021]

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

Application of interactive, computer technology to adolescent substance abuse prevention and treatment. [2008]

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

Web-based interventions to decrease alcohol use in adolescents: a Delphi study about increasing effectiveness and reducing drop-out. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Efficacy of a Web-Based Screening and Brief Intervention to Prevent Problematic Alcohol Use in Korea: Results of a Randomized Controlled Trial. [2022]