Developing a Digital Intervention to Prevent Risky Health Behaviors

Not Applicable

Completed

• Conditions: Substance Use
• Interventions: Behavioral: Single Session Family Intervention

• Registration Number: NCT06538922
• Lead Sponsor: University of Vermont

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.

Study Timeline

• Study Start: 2024-07-29
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-06
• Status Verified: 2024-12
• Primary Completion: 2024-12-05
• Study Completion: 2024-12-05
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Session Family Intervention	Single Session Family Intervention	Participants will complete a single session consultation intervention delivered remotely to provide family with feedback on using evidence-based family practices in daily life.

Primary Outcome Measures

Name	Time	Method
Feasibility of the single session intervention	2 hours (end of single session intervention)	Feasibility will be assessed by examining the percent of full session completers.
Acceptability of the single session intervention	2 hours (end of single session intervention)	Acceptability will be assessed by examining (1) single item mean scores and overall mean scores on the Program Feedback Scale, a scale used to evaluate acceptability and perceptions of SSIs, across participants. Higher scores indicated greater acceptability, range 1-5.
Parenting self-efficacy	3 Hours (before and after the single session)	average within-parent changes in key aspects of self-efficacy for parenting related to emotion and communication and evidence-based family practice with means on 10 items from the Self-Efficacy for Parenting Adolescents Scale; range 0 to 100; higher scores greater self-efficacy.

Trial Locations

Locations (1)

University of Vermont; 🇺🇸 Burlington, Vermont, United States