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Completed

NCT Number: NCT06538922

Developing a Digital Intervention to Prevent Risky Health Behaviors

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.

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Key information

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Single Session Family Intervention

Behavioral

A health coach will deliver a 2-hour single-session consultation to support parent-teen dyadis in applying evidence-based family skills in daily life. Participants will then practice daily on their own for the next 7 days.

Primary outcomes

  1. Acceptability of the single session intervention

    Time frame: 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.

  2. Feasibility of the single session intervention

    Time frame: 2 hours (end of single session intervention)

    Feasibility will be assessed by examining the percent of full session completers.

  3. Parenting self-efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study title

Parents and Teens Together (PATT): A Dyadic Digital Intervention to Prevent Substance Use Disorders

Acronym: PATT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Dec 10, 2024

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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