Clinical trial NCT06538922: Developing a Digital Intervention to Prevent Risky Health Behaviors
Official title: Parents and Teens Together (PATT): A Dyadic Digital Intervention to Prevent Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: adolescents
evidence-based family skills training
just-in-time adaptive intervention
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fifteen adolescents (aged 12-14) who are at high risk for or experimenting with substance use and their primary caregivers will complete a single appointment involving a baseline assessment, 2-hour single session evidence-based family skills training intervention, and follow-up assessment, followed by a weeklong daily diary, and semi-structured interview to guide the development of an mHealth app delivering a just-in-time adaptive intervention (JITAI).
Primary purpose: PREVENTION

Brief 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.

Detailed description: Young teens that experiment with alcohol, cannabis, or tobacco use before age 15 are 4x to 6x more likely to experience a substance use disorder (SUD). Early substance use (SU) is a detectable early danger sign for SUDs and is ideally responded to via indicated prevention intervention, which provides individualized support for youth with signs foreshadowing a SUD. The best practice indicated prevention for SUD in young teens that experiment with SU is behavioral family therapy. Behavioral family therapy shapes the development of family management skills including parental monitoring and family communication for problem-solving, relationship building, and talking about SU, via extensive supported practice. Unfortunately, families of young teens that experiment with or at high risk for experimenting with SU are unable to readily access behavioral family therapy for indicated prevention. In this project, we are launching the development of Parents and Teens Together (PATT), a dyadic digital parent-teen intervention to bridge this accessibility gap. PATT will leverage a blended, virtual and health coach-led, single session intervention (SSI) and just-in-time adaptive intervention (JITAI) technology to scale-up access to personalized instruction and support for young teens at high risk for or experimenting with SU and their parents.

This project will follow an open trial and mixed methods design. Participants will be 15 young teens, 12 to 14 years of age, who meet a high risk factor for or are experimenting with SU and their primary caregivers. The study has two primary aims. First, the investigators will assess the acceptability, feasibility, and costs of an SSI for evidence-based family skills training. Parent-teen dyads will complete a 2-hour SSI delivered virtually by a health coach that provides consultation on using evidence-based family skills. The investigators will examine participant engagement, program feedback, and costs of training and supervision for each parent-teen dyad.

Second, using a participatory design process, the investigators will conduct needs assessments to guide JITAI app design and develop a JITAI prototype. At the end of the SSI, the dyads will be asked to practice evidence-based family skills for one week. Dyads will report via a weeklong daily diary on the frequency and quality of their interactions when engaging in those skills. Then, dyads will complete a semi-structured interview. The investigators will assess daily diaries and semi-structured interviews to identify support needs and desired functions for the JITAI.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the single session intervention
timeFrame: 2 hours (end of single session intervention)
measure: Feasibility of the single session intervention
timeFrame: 2 hours (end of single session intervention)
measure: Parenting self-efficacy
timeFrame: 3 Hours (before and after the single session)
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Amy Hughes Lansing, PhD
role: PRINCIPAL_INVESTIGATOR
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