Norms Re-education to Promote Engagement in Parent-based Interventions

Официальное название

Norms Re-education to Promote Engagement in Parent-based Interventions: A Type 1 Implementation-effectiveness Trial

Обзор

A randomized controlled trial (RCT) will be conducted to evaluate both the short-term and long-term efficacy of innovative, incentive-free parent-based interventions (PBIs) designed to reduce underage drinking on college campuses. Although the current NIAAA-recommended Parent Handbook has shown modest effects, our preliminary work suggests that combining personalized normative feedback (PNF) delivered through a social media-inspired app with psychoeducational content can effectively decrease alcohol-related risk. In this large, multi-site trial with 2,040 first-year students, we will examine the short- and long-term effects of the experimental app-based PNF program (PNF+ PBI) compared to an email-based social norms marketing campaign (SNMC+ PBI), the Parent Handbook (PH+ PBI), and an assessment-only control on alcohol use and consequences (primary outcomes). Parent alcohol approval and communication will also be assessed as potential mediators of intervention effects (secondary outcomes). The researchers hypothesize that students whose parents receive PNF+ and SNMC+ PBIs will report lower levels of alcohol use and fewer alcohol-related consequences compared to those whose parents receive PH+ PBI or no intervention. It is also expected that parental approval will be lower and alcohol-related communication will be higher in these two experimental conditions, relative to PH+ PBI and no intervention.

Подробное описание

A randomized controlled trial (RCT) will be conducted to evaluate the feasibility and efficacy of innovative, incentive-free parent-based interventions (PBIs) designed to reduce underage drinking on college campuses. Incoming first-year students will be invited to complete an online baseline survey during the summer prior to matriculation to assess alcohol use and related behaviors. An automated randomizer embedded in the survey will assign students (and thus their parents) to one of four conditions: an experimental app-based personalized normative feedback program (PNF+ PBI), an email-based social norms marketing campaign (SNMC+ PBI), the NIAAA-recommended Parent Handbook (PH+ PBI), or an assessment-only control group. Parents in the PBI conditions will receive access to their assigned program in July or August (immediately following their students completion of the baseline survey). Students will complete a total of four surveys: the baseline assessment and three follow-up surveys at one month, six months, and twelve months post-matriculation. The researchers hypothesize that students whose parents are assigned to the experimental app-based PNF and email-based SNMC conditions will report lower alcohol use and fewer alcohol-related consequences compared to those whose parents receive the Parent Handbook or no intervention. In addition, it is expected that these experimental conditions will yield lower parental alcohol approval and higher levels of alcohol-related communication, which will serve as potential mediators of the intervention effects.

Вмешательства

• Поведенческое PNF+ PBI
  Parents of participating students assigned to the PNF+ PBI condition will receive an email invitation to sign up for a Parent-Based Intervention app. This app features six personalized normative feedback (PNF) quizzes and provides tailored videos and readings based on responses to these quizzes. Parents will create an account and complete the first PNF quiz, after which they will immediately receive their initial set of tailored content. They can then explore additional app content at their conv
• Поведенческое SNMC+ PBI
  Parents of participating students randomized to this condition will receive a series of 6 emails (delivered weekly) in August and September. Each email will include risk-reducing normative facts and a relevant tip for communicating with students about alcohol-related risks.
• Поведенческое PH+ PBI
  Parents of participating students randomized to this condition will receive an email introducing the PBI including a link to access the Handbook online. Parents can explore the Handbook at their own pace.

Первичные конечные точки

• Change in Baseline Daily Drinking from Baseline to 1 Month Post Intervention [Срок оценки: baseline, 3 months]
• Change in Baseline Daily Drinking from Baseline to 7 Months Post Intervention [Срок оценки: baseline, 7 months]
• Change in Baseline Daily Drinking from Baseline to 12 Months Post Intervention [Срок оценки: baseline, 12 months]
• Change in Peak Drinking from Baseline to 1 Month Post Intervention [Срок оценки: baseline, 1 month]
• Change in Peak Drinking from Baseline to 7 Months Post Intervention [Срок оценки: baseline, 7 months]
• Change in Peak Drinking from Baseline to 12 Months Post Intervention [Срок оценки: baseline, 12 months]
• Change in Heavy Episodic Drinking from Baseline to 1 Month Post Intervention [Срок оценки: baseline, 1 month]
• Change in Heavy Episodic Drinking from Baseline to 7 Months Post Intervention [Срок оценки: baseline, 7 months]
• Change in Heavy Episodic Drinking from Baseline to 12 Months Post Intervention [Срок оценки: baseline, 12 months]
• Change in High Intensity Drinking from Baseline to 1 Month Post Intervention [Срок оценки: baseline, 1 month]

Вторичные конечные точки (6)

• Change in Perceived Parental Approval of Underage Drinking from Baseline to 1 Month Post Intervention [Срок оценки: baseline, 1 month]
• Change in Perceived Parental Approval of Underage Drinking from Baseline to 7 Months Post Intervention [Срок оценки: baseline, 7 months]
• Change in Perceived Parental Approval of Underage Drinking from Baseline to 12 Months Post Intervention [Срок оценки: baseline, 12 months]
• Change in Perceived Frequency of Parent Communication from Baseline to 1 Month Post Intervention [Срок оценки: baseline, 1 month]
• Change in Perceived Frequency of Parent Communication from Baseline to 7 Months Post Intervention [Срок оценки: baseline, 7 months]
• Change in Perceived Frequency of Parent Communication from Baseline to 12 Months Post Intervention [Срок оценки: baseline, 12 months]

Критерии участия

Критерии включения

• LMU/Lehigh incoming first-year college student who is17-20 years of age
• Parent/legal guardian with an email address on file with the university
• A United States resident
• Provide informed consent/assent

Критерии исключения

• Younger than 17 or older than 20 years of age
• Not an incoming first-year college students at LMU/Lehigh
• Parent or legal guardian does not have an email address on file with the university
• Not residents of the United States
• Did not provide informed consent/assent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Loyola Marymount — Los Angeles

Идентификаторы

NCT: NCT06871982 · 1R01AA030904-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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