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NCT Number: NCT05897164

Mobile Technology to Reduce Teen Substance Misuse

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.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland, Baltimore, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Youth:

  • Resides in United States
  • 13-17 years of age
  • Fluent in English
  • Possesses and is the primary user of an Android or iPhone-based smartphone with a data plan that they use on a daily basis
  • Currently residing in the same household with the linked caregiver/legal guardian participant at least five days a week
  • Meets criteria for mild-moderate or severe SA (for any drug or alcohol) on the Screening to Brief Intervention (S2BI), indicated by answering that they have used any substance at least once per month within the past 90 days.
  • Possesses and is the primary user of an Android or iPhone-based smartphone with a data plan

Caregivers:

  • Resides in United States
  • 18 years or older
  • Fluent in English
  • Owns and is the primary user of an Android or iPhone-based smartphone with a data plan that they use on a daily basis
  • Able and willing to receive and send several (1-3 times/week) text messages from study staff during study participation
  • Is the primary caregiver of a youth aged 13-17 years who lives in the caregiver's home at least five days a week
  • Caregiver indicates a substance concern for the target youth, defined as either a+b OR c:
  • uses alcohol, marijuana, and/or another substance, AND
  • 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

  • The target youth participated in counseling or another form of treatment (e.g., medication assisted treatment) because of a concern about alcohol, marijuana, or other substance use.

Exclusion criteria

Youth:

  • Participated in previous iKinnect or WisePath for Teens research in the past 2 years

Caregivers:

  • Participated in previous iKinnect or WisePath for Teens research in the past 2 years
  • Currently involved with the child protective service system due to a concern about child maltreatment (i.e., abuse or neglect).

Treatment and study plan

WisePath for Teens

Other

WPT is a paired mobile phone app for use on both Android and iOS operating systems by youth experiencing SA and their parents/guardians.

Other names: WPT

Peer Support Services (PSS)

Behavioral

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.

Control

Device

Website with icon on participant's phone with Android or iOS operating systems.

Other names: WILLOW

Primary outcomes

  1. Change in Timeline Followback Method Assessment (TLFB)

    Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)

    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.

  2. Change in Global Assessment of Individual Needs-Q3 (GAIN)

    Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)

    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.

  3. Change in Achenbach (Child/Adult) Behavior Checklist

    Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)

    A widely used 123-item caregiver report form used to assess youth behavioral and emotional problems.

  4. Change in Family Environment Scale (FES)

    Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)

    A widely-used measure of family conflict (12 items) and cohesion (15 items).

  5. Change in Parent-Adolescent Relationship Scale (PARS)

    Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)

    A 15-item reliable measure of parent-teen connectedness, hostility, and involvement.

  6. Change in Alabama Parenting Questionnaire (APQ)

    Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)

    A psychometrically sound measure of positive parenting (6 items), monitoring/supervision (10 items), and discipline consistency (6 items).

  7. Change in Perceived Stress Scale (PSS)

    Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)

    A reliable 10-item measure to assess parents' overall stress in parenting over the past two weeks.

  8. Change in Parent Locus of Control (PLC)

    Time frame: Baseline (Time 1), 1-4 weeks (Time 2), 5-8 weeks (Time 3), and 9-12 weeks (Time 4)

    A scale to measure parents' feelings of helplessness (10 items) and efficacy in dealing with parenting challenges (10 items).

  9. App Satisfaction Survey

    Time frame: 9-12 weeks (Time 4)

    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.

Other outcomes

  1. Demographics Questionnaire

    Time frame: Eligibility Screening

    Self-report measure to collect demographics from participants in this study. Questions include items about gender, race, and ethnicity.

  2. Screening to Brief Intervention (S2BI) scale

    Time frame: Eligibility Screening

    8-item scale assessing the frequency and severity of use with 90% and 94% sensitivity to detect moderate to severe SA, respectively.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Kelley Brimer, MS

CONTACT

[email protected]

206-455-7934

Samantha Daniels

CONTACT

[email protected]

206-455-7934

Sponsors and collaborators

Lead sponsor

Evidence-Based Practice Institute, Seattle, WA

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Maryland, Baltimore

Registry information

Official study title

iKinnect Mobile Technology to Reduce Teen Substance Misuse and Health Disparities

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 9, 2023
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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