Developing a Digital Intervention to Prevent Risky Health Behaviors (NCT06538922) | Clinical Trial Compass
CompletedNot Applicable
Developing a Digital Intervention to Prevent Risky Health Behaviors
United States9 participantsStarted 2024-07-29
Plain-language summary
The project will launch the development of Parents and Teens Together (PATT), a dyadic digital parent-teen prevention intervention, for families of young teens experimenting or at high risk for experimenting with substance use (SU) that can provide personalized support for learning and practicing evidence-based family skills. This scalable intervention will combine a blended, virtual and health coach-led, single-session intervention (SSI) for evidence-based family skills with an mHealth app delivering a just-in-time adaptive intervention (JITAI) to support the use of family skills in daily life. As a first step in the iterative design of PATT, this project will test the acceptability, feasibility and costs of the SSI and engage in a participatory design process to finalize the plan for an initial JITAI prototype. For young teens experimenting or at risk for experimenting with SU and their parents, ready access to a scalable prevention program that closely mirrors and extends the in-time support provided in behavioral family therapy is essential for SUD prevention.
Who can participate
Age range
12 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Teen participant is aged 12-14 years old
* At least one risk/behavior: Teen reports experimenting with substance (alcohol, tobacco, or marijuana) use once or twice, in the past year; a history of substance use disorder in teen's immediate family; Teen's close family, whom they have regular contact with, such as siblings or other caregivers, currently use (in past 12 months) substances; teen reports close friends experimented with tobacco, alcohol, or marijuana?
* Teen and parent participant are able to complete study activities in English
* Teen and parent participant have access to broadband or cellular internet for study activities
Exclusion Criteria:
* Teen participant is a ward of the state
* Teen diagnosis of a substance use disorder
* Parent or teen active psychosis, or severe medical or psychiatric illness that would limit ability to participate in study activities
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability of the single session intervention
Timeframe: 2 hours (end of single session intervention)
2
Feasibility of the single session intervention
Timeframe: 2 hours (end of single session intervention)
3
Parenting self-efficacy
Timeframe: 3 Hours (before and after the single session)