Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538922
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Developing a Digital Intervention to Prevent Risky Health Behaviors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Parents and Teens Together PATT A Dyadic Digital Intervention to Prevent Substance Use Disorders
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATT
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None