An interventional study of WisePath for Teens and Peer Support Services (PSS) in Substance Use, Substance Abuse and Suicide, sponsored by Evidence-Based Practice Institute, Seattle, WA. Recruiting at 2 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Evidence-Based Practice Institute, Seattle, WA · Not applicable, Interventional, and Other
The goal of this study is to test the newly expanded WisePath for Teens (WPT) for substance use app, a direct-to-consumer paired mobile phone app for iOS and Android platforms that supports parents/guardians in delivering evidence-based techniques to reduce youth substance abuse and co-occurring mental health problems. This project will expand WPT for use with a general population of teens with problematic substance use and their parents to reduce substance abuse, its harmful effects, opioid overdoses, and progression to substance use disorders, as well as other behavioral health problems that are exacerbated by substance abuse and/or interfere with substance abuse treatment.
This project will test the newly expanded WisePath for Teens (WPT), a paired mobile app to support parents delivering, and youth receiving, evidence-based practices to reduce youth's substance abuse (SA) and other significant behavioral health problems that commonly co-occur with SA, exacerbate SA, and/or interfere with youth's treatment. Through a collaborative "discussion" with a chatbot, WPT will collect information about the youth's substance use and other behavioral health problems, utilizing methods designed to enhance motivation and engagement. Using a shared decision-making process, WPT will configure to address the youth's specific SA triggers and functions and other identified top problems (e.g., depression, stress, insomnia). The platform will generate recommended parent- and family-focused strategies for the parent app and will use the parent-teen interactive card system to deliver evidence-based family therapy tasks, tailoring parent notifications to match specific teen risks.
This study includes a 12-week randomized controlled trial (RCT) with 300 youth participants aged 13-17 years and their primary caregiver (dyads). Dyads will be randomly assigned to use WisePath for Teens (WPT; n=100 dyads), WisePath for Teens plus parental support by an assigned peer support specialist (WPT+PSS; n=100 dyads), or an active control condition involving access to a webpage of resources relating to substance use and general stress reduction; presented resources are updated every 2-3 days (Control; n=100 dyads). We will also provide simple instructions on how to save the webpage to their phone's home screen (similar to an app icon) to make access easier and more like accessing an installed mobile app. Youth participants will be matched across condition on age and substance use severity. Participants will be assessed at three time points: baseline, one intermediate time point (at either 4 weeks or 8 weeks), and 12 weeks.
The study uses a Planned Missingness Design that assesses change over time for each participant across three time points spread across four assessment opportunities lasting a total of 12 weeks. Specifically, each study participant will complete measures at baseline and also at 12 weeks; each family dyad will be randomly assigned to also complete one additional assessment at either week 4 or week 8. We predict that participants in both WPT conditions will report significantly greater decreases in substance use and associated risky behaviors, greater decreases in stress, greater increases in capacity for coping with distress, and superior satisfaction ratings compared to control participants. We predict in comparison to WPT use alone, those in the enhanced condition will have superior outcomes across all measures.
Primary youth-reported outcomes include: substance use and related problems (school and crime/violence); recovery environment quality; mental health (internalizing and externalizing symptoms), and family functioning (conflict, involvement). Primary caregiver-reported outcome variables include: family functioning (conflict, involvement), parenting skills (monitoring/supervision, discipline consistency, positivity), and parenting cognitions (perceived stress and efficacy). Caregivers will also report on youth mental health symptoms. App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined as between-groups differences for WPT vs. WPT+PSS arms, as well as potential predictors of changes across time in caregiver and youth outcomes.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 600 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Evidence-Based Practice Institute, Seattle, WA is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Youth:
Caregivers:
Caregiver indicates a substance concern for the target youth, defined as either a+b OR c:
expresses that they are concerned (a score of 3 or higher) about that use on a 5-pt Likert scale (3 = concerned, 4 = very concerned, 5 = extremely concerned).
OR
EXCLUSION CRITERIA
Youth:
Caregivers:
Youth and parents allocated to the WPT condition will use WPT, a newly developed app to support parents delivering (and for youth, receiving) evidence-based practices to reduce youth's substance abuse and other significant behavioral health problems that commonly co-occur with substance abuse, exacerbate substance abuse and/or interfere with their treatment.
Other: WisePath for Teens
Youth and parents allocated to the WPT + PSS condition will use WPT paired with a family peer support specialist.
Other: WisePath for Teens · Behavioral: Peer Support Services (PSS)
Caregivers and teens allocated to the control condition will each be provided with access to the study-developed webpage that has links to freely-available, online, high-quality resources related to teen substance use and general stress reduction, with all links tailored to each webpage's intended audience (i.e., caregivers will be given links to parent-facing resources and teens will be given links to teen-facing or teen-appropriate webpages and resources). Dyads will receive simple instructions on how to save the webpage to their phone's home screen (similar to an app icon) to make access easier and more like accessing an installed mobile app.
Device: Control
WPT is a paired mobile phone app for use on both Android and iOS operating systems by youth experiencing SA and their parents/guardians.
Also known as: WPT
PSS are provided by people with lived experience with histories of adolescent substance abuse and are now in recovery who are also certified as peer support specialists. A specialist will virtually (e.g., over the phone, screensharing) meet with families regularly to provide support and ensure that families are able to use iKinnect-SA and access the app's features.
Website with icon on participant's phone with Android or iOS operating systems.
Also known as: WILLOW
Change in Timeline Followback Method Assessment (TLFB)
The TLFB assesses use of alcohol and 13 different drugs over the past 30 days. It involves asking clients to retrospectively estimate their drug, marijuana or cigarette use.
Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)
Change in Global Assessment of Individual Needs-Q3 (GAIN)
Scales from GAIN specifically identify and address substance use frequency (3 items), substance problems (5 items), crime/violence (5 items), and recovery environment risk (9 items) and are well-validated for adolescents.
Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)
Change in Achenbach (Child/Adult) Behavior Checklist
A widely used 123-item caregiver report form used to assess youth behavioral and emotional problems.
Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)
Change in Family Environment Scale (FES)
A widely-used measure of family conflict (12 items) and cohesion (15 items).
Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)
Change in Parent-Adolescent Relationship Scale (PARS)
A 15-item reliable measure of parent-teen connectedness, hostility, and involvement.
Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)
Change in Alabama Parenting Questionnaire (APQ)
A psychometrically sound measure of positive parenting (6 items), monitoring/supervision (10 items), and discipline consistency (6 items).
Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)
Change in Perceived Stress Scale (PSS)
A reliable 10-item measure to assess parents' overall stress in parenting over the past two weeks.
Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)
Change in Parent Locus of Control (PLC)
A scale to measure parents' feelings of helplessness (10 items) and efficacy in dealing with parenting challenges (10 items).
Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)
App Satisfaction Survey
An 8-item survey used in EBPI's previous research and focuses on the app's ease of use and helpfulness on a five-point rating scale. The survey also captures an overall satisfaction rating for the app used on a 100-point scale.
Time frame: 9-12 weeks (Time 4)
Demographics Questionnaire
Self-report measure to collect demographics from participants in this study. Questions include items about gender, race, and ethnicity.
Time frame: Eligibility Screening
Screening to Brief Intervention (S2BI) scale
8-item scale assessing the frequency and severity of use with 90% and 94% sensitivity to detect moderate to severe SA, respectively.
Time frame: Eligibility Screening
Plan to share: Yes — The final dataset will include self-reported demographic and behavioral data from youth and parent/guardian participants in the randomized controlled trial. The dataset will include sensitive data from youth participants aged 13-17 years regarding substance use, suicidal behavior, and other behavioral health problems. Thus, the de-identified dataset will be distributed by Drs. Dimeff and Schaeffer to those that request it and only under a data-sharing agreement that includes: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate security protections; and (3) a commitment to destroying the data after analyses are completed.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: These materials will become available upon completion of study analyses.
Access criteria: The de-identified dataset will be distributed only under a data-sharing agreement that includes: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate security protections; and (3) a commitment to destroying the data after analyses are completed.
Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.
Of 40 industry-sponsored interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's planned 3 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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Evidence-Based Practice Institute, Seattle, WA