LaunchPad: Supporting Healthy Decisions and Preventing Drug Use After High School

Официальное название

Preventing Drug Use Onset and Progression Toward Addiction During a Critical Transition Period: Optimizing an Online Intervention for High School Seniors

Обзор

LaunchPad is an online substance use prevention program for high school seniors. The program is designed to help seniors develop skills and make informed decisions as they transition from high school to young adulthood. The purpose of this clinical trial is to learn whether individual LaunchPad lessons improve the specific attitudes, intentions, and skills they are designed to address. For example, researchers will examine whether the stress management lesson increases students' intentions to use healthy ways of managing stress. The main question this study aims to answer is: Does each individual LaunchPad lesson improve the specific outcomes it was designed to address? Researchers will compare students who receive a particular lesson with students who do not receive that lesson to determine whether the lesson changes the intended outcome. Participants will: * Complete a brief baseline survey * Complete two introductory online lessons * Complete one or more randomly assigned LaunchPad lessons * Complete a brief follow-up survey All surveys and lessons will be completed online.

Подробное описание

LaunchPad is an online substance use prevention program designed for high school seniors as they prepare for the transition to young adulthood. The program is being developed and optimized using the Multiphase Optimization Strategy (MOST), an engineering-inspired framework for building effective and efficient behavioral interventions. Rather than evaluating the program as a single intervention "package", researchers evaluate individual lessons and determine which lessons contribute meaningfully to desired outcomes before assembling an effective and efficient (i.e., "optimized") intervention package.

The current study, Trial I, is the first of two planned trials in the Optimization Phase of MOST. Trial I is designed to evaluate whether five theory-informed LaunchPad lessons produce their intended short-term effects on risk and protective factors associated with substance use during the transition out of high school. All participating students will receive two introductory lessons. Students will then receive different combinations of five additional lessons that target factors such as perceptions of substance use among young adults, stress management skills, making friends without using alcohol or other drugs, and other skills and beliefs associated lower risk of substance use among young adults.

The study will recruit approximately 48 high schools across the United States. To make it easier for schools and because students within a school may discuss intervention content, schools will be assigned to study conditions rather than individual students. Participating schools will be randomly assigned to one of 16 experimental conditions using a cluster-randomized fractional factorial design. This design allows researchers to efficiently estimate the effect of each lesson on its targeted outcomes.

Parents or guardians of seniors at each participating high school will be notified about the study and provided an opportunity to opt their child out of participation. Students whose parents do not opt them out and who provide assent (\<18 years old) or consent (18 or older), will be eligible to participate. When required by participating schools, active (opt in) consent procedures will be used for parents or guardians. Schools will be able to implement the program between September 1 and April 2, depending on when it works for them. Participating schools will complete: a brief baseline survey, the LaunchPad lessons assigned to their school, and an immediate post-intervention survey.

Students will access LaunchPad through a learning management system using a computer, tablet, or smartphone. Survey responses will be linked across assessment periods using unique study identifiers generated within the course management system.

The primary purpose of Trial I is to determine whether each lesson changes the factors it was designed to influence. Primary outcomes include changes in the targeted attitudes, beliefs, perceptions, and skills assessed immediately following intervention completion. Information from participant surveys, behavioral engagement data, and participant feedback will also be used to assess the acceptability and usability of the lessons and to identify opportunities for improvement.

Findings from Trial I will be used to identify which lessons do not yet achieve the desired effects on their targeted outcomes. Findings will be combined with feedback from participating students, young adults, school staff, and expert consultants to inform revisions to lesson content and delivery. The revised lessons will be tested in a subsequent optimization trial.

Вмешательства

• Поведенческое Introduction
  Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans.
• Поведенческое Norms re: Protective Behavior Strategies (PBS)
  Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use.
• Поведенческое Life Skills
  Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety.
• Поведенческое Norms re: Bystander Intervention Strategies
  Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers.
• Поведенческое Making Friends
  Teaches strategies to make friends without SU.
• Поведенческое Norms about Substance Use
  Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU.

Первичные конечные точки

• Substance Use Injunctive Norms [Срок оценки: This measure will be completed at the pretest and immediate posttest]
• Substance Use Descriptive Norms [Срок оценки: This measure will be completed at the pretest and immediate posttest.]
• Social self-efficacy [Срок оценки: This measure will be completed at the pretest and immediate posttest.]
• Beliefs about social belonging without substance use [Срок оценки: This measure will be completed at the pretest and immediate posttest.]
• Substance use refusal self efficacy [Срок оценки: This measure will be completed at the pretest and immediate posttest.]
• Injunctive norms about Protective Behavioral Strategies [Срок оценки: This measure will be completed at the pretest and immediate posttest.]
• Injunctive norms about consequences of substance use [Срок оценки: This measure will be completed at the pretest and immediate posttest.]
• Attitudes about using Protective Behavioral Strategies [Срок оценки: This measure will be completed at the pretest and immediate posttest.]
• Intentions to use stress management skills [Срок оценки: This measure will be completed at the pretest and immediate posttest.]
• Self efficacy to use different stress management skills [Срок оценки: This measure will be completed at the pretest and immediate posttest.]

Критерии участия

Schools:

• Public or private school in the U.S. enrolling 12th grade students
• Agree to (1) provide us contact information for students and parents (or to send study information to students and parents themselves), (2) identify a school contact person (typically a school counselor) who will work with us to carry out the study (recruitment, pretest survey, intervention deployment, posttest survey), and (3) either provide school time to complete the intervention or integrate the intervention into a class (e.g., as an out-of-class assignment)

Students:

• Enrolled as a 12th grade student at one of the participating schools
• Have not completed a previous version of the intervention before
• Between the ages of 15 and 21 years of age

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07655609 · LaunchPad · 5R01DA058697-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗