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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if web-based programs can assist teens with mild to moderate substance use and related behavioral issues. It compares two online approaches: ePACE, which is personalized, and eFACE, which is more structured and fixed. Researchers seek to assess whether these programs improve substance use and behavioral health more effectively than no treatment and if ePACE outperforms eFACE. Teens experiencing mild or moderate substance use issues and mental health challenges, who live at home with a parent or guardian, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative online treatments that could significantly enhance teen behavioral health.

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 prior data suggests that these web-based interventions are safe for adolescents?

Research has shown that online programs like eFACE and ePACE are generally safe for teenagers. Studies have found these digital tools to be secure and well-liked by users.

ePACE and eFACE use an online platform to assist teens with activities that promote positive behavior changes, focusing on issues like drug use and emotional stress. Being online, they are less likely to cause physical side effects than traditional treatments.

Both programs assess multiple issues to customize the experience for each person. This personalization can enhance engagement without adding significant risks. Importantly, research on similar digital programs suggests they effectively and safely address behavioral health issues.

Overall, ePACE and eFACE offer promising options for teenagers needing early help with substance use and related problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ePACE and eFACE because they offer innovative, web-based interventions for adolescent substance use and behavioral health. Unlike traditional therapies, which often involve in-person counseling sessions, ePACE is personalized and interactive, giving individualized feedback based on the user's responses to various activities and quizzes. This tailored approach aims to actively engage youth in their behavior change efforts. In contrast, eFACE provides structured modules without personalization, offering a consistent learning experience. Both interventions provide accessible, technology-driven alternatives to the usual face-to-face therapy sessions, potentially reaching more adolescents in need of support.

What evidence suggests that this trial's web-based interventions could be effective for adolescent substance use and behavioral health?

This trial will compare two web-based interventions for adolescent substance use and behavioral health: ePACE and eFACE. Research has shown that digital programs like ePACE, which participants in this trial may receive, can help prevent and reduce substance use among teenagers. Past studies have demonstrated that these personalized online methods effectively engage young people and address various issues, such as drug use and stress. ePACE is unique because it provides feedback based on each person's answers, guiding them to change their behavior more effectively.

Meanwhile, eFACE, another treatment option in this trial, has been associated with improvements in mental health and reductions in unhealthy behaviors through structured digital tools. eFACE follows a fixed approach, delivering the same content in a set order to all participants. Although it isn't personalized, this systematic method has still been linked to positive results in reducing substance use.

Both ePACE and eFACE have shown potential in improving the lives of teenagers dealing with substance use and related challenges. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-substance-related-disorders-11-2023-9753d

Web-Based Interventions for Adolescent Substance Use ... 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 ...

2. ctv.veeva.com ctv.veeva.com/study/adolescent-screening-and-personalized-intervention-resource-for-enhancement-of-behavioral-health-and

Adolescent Screening and Personalized Intervention ... Youth assigned to ePACE and eFACE are expected to exhibit greater improvements compared to those assigned to WC, with the effects of ePACE ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11544686/

Effective elements of eHealth interventions for mental ... The aim of this pre-registered systematic review is to identify elements of eHealth interventions that improve mental health and well-being in children and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589750019300883

Effectiveness of school-based eHealth interventions to ... Primary outcomes of interest were the prevention or reduction of unhealthy behaviours, or improvement in healthy behaviours of the six behaviours. Outcomes were ...

5. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2022.931276/full

Effectiveness of a hybrid digital substance abuse ... Results: There were significant reductions in substance use for the hybrid digital condition compared to the control condition as well as significant increases ...

6. reporter.nih.gov reporter.nih.gov/search/I_bJWIRR_0Kb3TKRVha0zw/project-details/11077888

Project Details - NIH RePORTER This proposed fast-track seeks to adapt iKinnect to reduce substance use disorders while also preventing NSSI, suicidal behaviors (ideation, planning, attempts) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9381808/

Effectiveness of a hybrid digital substance abuse ... A hybrid digital approach to substance abuse prevention is effective and offers potential for overcoming common barriers to widespread adoption and high- ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076241294105

Effective elements of eHealth interventions for mental ... In adolescents, CBT is commonly used to treat depressive symptoms and disorders and has been found to be effective in reducing mental health ...