Mobile Technology to Reduce Teen Substance Misuse
iKinnect Mobile Technology to Reduce Teen Substance Misuse and Health Disparities
1 other identifier
interventional
600
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedStudy Start
First participant enrolled
August 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
August 20, 2026
August 1, 2026
3 months
May 22, 2023
August 18, 2026
Conditions
Outcome Measures
Primary Outcomes (9)
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.
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.
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.
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).
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.
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).
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.
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).
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.
9-12 weeks (Time 4)
Other Outcomes (2)
Demographics Questionnaire
Eligibility Screening
Screening to Brief Intervention (S2BI) scale
Eligibility Screening
Study Arms (3)
WPT
EXPERIMENTALYouth 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.
WPT + PSS
EXPERIMENTALYouth and parents allocated to the WPT + PSS condition will use WPT paired with a family peer support specialist.
WILLOW
ACTIVE COMPARATORCaregivers 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.
Interventions
WPT is a paired mobile phone app for use on both Android and iOS operating systems by youth experiencing SA and their parents/guardians.
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.
Eligibility Criteria
You may qualify if:
- Youth:
- Resides in United States
- 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
- 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
- +4 more criteria
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Evidence-Based Practice Institute
Seattle, Washington, 98126, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Dimeff, PhD
Chief Scientific Officer, Evidence-Based Practice Institute
- PRINCIPAL INVESTIGATOR
Cindy Schaeffer, PhD
Associate Professor, University of Maryland-Baltimore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants will be blind to condition other than the one to which they are assigned; Investigators will be blind to condition until data analysis is complete.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 9, 2023
Study Start
August 18, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
August 20, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.