Contemporary clinical trials · 2026
Remotely delivered parents helping parents for youth nicotine vaping cessation recruited via electronic health records: Protocol for a feasibility randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Michaud Tzeyu L, Reyes Sara, Guenzel Nicholas, Guastello Paula, Kerns Ellen, Berkman Meredith, Fuhrman Dorian, Skrobola Lori, Joyce Caroline, Nabi Emara, Winickoff Jonathan P, Dai Hongying Daisy
Аннотация
BACKGROUND: Quitting vaping continues to be challenging for adolescents, with most reporting unsuccessful attempts to quit. The existing evidence base lacks interventions that combine parental support, peer-to-peer coaching for parents, and developmentally appropriate components for adolescents.
PURPOSE: This study aims to outline the study design and protocol of a pilot trial examining the feasibility and preliminary effectiveness of a multicomponent vaping cessation intervention, focusing on parent-to-parent coaching support, designed for adolescents aged 15-18 years.
METHODS: This study applies a two-arm, parallel-group pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary effectiveness of the Parents Helping Parents for Youth Vaping Cessation (PhP-VX) intervention over a 6-month study duration. A total of 100 parent-adolescent dyads will be randomized in a 1:1 ratio to either the PhP-VX intervention arm or the waitlist control arm. The 12-week PhP-VX intervention includes one-on-one coaching sessions for parents delivered by trained parent coaches and supplementary vaping cessation e-learning modules. Primary outcomes include predefined benchmarks for acceptability, defined as a mean satisfaction score of ≥3.5 on a 5-point scale and ≥ 75% of parent participants reporting that they would recommend the program. Feasibility outcomes include reach, recruitment, engagement, and retention. Preliminary effectiveness outcome includes self-reported 7-day point prevalence abstinence at Months 1, 3, and 6. Recruitment for the study commenced in March 2026 and is anticipated to conclude in June 2027.
CONCLUSION: Findings from this pilot trial will inform the development of future family-based youth vaping cessation interventions and guide refinement of the current protocol for a large-scale trial.
TRIAL REGISTRATION: ClinicalTrials.gov NCT07207850.
PURPOSE: This study aims to outline the study design and protocol of a pilot trial examining the feasibility and preliminary effectiveness of a multicomponent vaping cessation intervention, focusing on parent-to-parent coaching support, designed for adolescents aged 15-18 years.
METHODS: This study applies a two-arm, parallel-group pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary effectiveness of the Parents Helping Parents for Youth Vaping Cessation (PhP-VX) intervention over a 6-month study duration. A total of 100 parent-adolescent dyads will be randomized in a 1:1 ratio to either the PhP-VX intervention arm or the waitlist control arm. The 12-week PhP-VX intervention includes one-on-one coaching sessions for parents delivered by trained parent coaches and supplementary vaping cessation e-learning modules. Primary outcomes include predefined benchmarks for acceptability, defined as a mean satisfaction score of ≥3.5 on a 5-point scale and ≥ 75% of parent participants reporting that they would recommend the program. Feasibility outcomes include reach, recruitment, engagement, and retention. Preliminary effectiveness outcome includes self-reported 7-day point prevalence abstinence at Months 1, 3, and 6. Recruitment for the study commenced in March 2026 and is anticipated to conclude in June 2027.
CONCLUSION: Findings from this pilot trial will inform the development of future family-based youth vaping cessation interventions and guide refinement of the current protocol for a large-scale trial.
TRIAL REGISTRATION: ClinicalTrials.gov NCT07207850.