Clinical trial NCT06871982: Norms Re-education to Promote Engagement in Parent-based Interventions
Official title: Norms Re-education to Promote Engagement in Parent-based Interventions: A Type 1 Implementation-effectiveness Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Underage Drinking
Lead sponsor: Loyola Marymount University
Sponsor class: OTHER
Collaborators: name: Lehigh University
First posted: 2025-03-12
Enrollment: 2040
Sex: ALL
Minimum age (years): 17
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Baseline Daily Drinking from Baseline to 1 Month Post Intervention
timeFrame: baseline, 3 months
measure: Change in Baseline Daily Drinking from Baseline to 7 Months Post Intervention
timeFrame: baseline, 7 months
measure: Change in Baseline Daily Drinking from Baseline to 12 Months Post Intervention
timeFrame: baseline, 12 months
measure: Change in Peak Drinking from Baseline to 1 Month Post Intervention
timeFrame: baseline, 1 month
measure: Change in Peak Drinking from Baseline to 7 Months Post Intervention
timeFrame: baseline, 7 months
measure: Change in Peak Drinking from Baseline to 12 Months Post Intervention
timeFrame: baseline, 12 months
measure: Change in Heavy Episodic Drinking from Baseline to 1 Month Post Intervention
timeFrame: baseline, 1 month
measure: Change in Heavy Episodic Drinking from Baseline to 7 Months Post Intervention
timeFrame: baseline, 7 months
measure: Change in Heavy Episodic Drinking from Baseline to 12 Months Post Intervention
timeFrame: baseline, 12 months
measure: Change in High Intensity Drinking from Baseline to 1 Month Post Intervention
timeFrame: baseline, 1 month
measure: Change in High Intensity Drinking from Baseline to 7 Months Post Intervention
timeFrame: baseline, 7 months
measure: Change in High Intensity Drinking from Baseline to 12 Months Post Intervention
timeFrame: baseline, 12 months
measure: Change in Alcohol-Related Consequences from Baseline to 1 Month Post Intervention
timeFrame: baseline, 1 month
measure: Change in Alcohol-Related Consequences from Baseline to 7 Months Post Intervention
timeFrame: baseline, 7 months
measure: Change in Alcohol-Related Consequences from Baseline to 12 Months Post Intervention
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Change in Perceived Parental Approval of Underage Drinking from Baseline to 1 Month Post Intervention
timeFrame: baseline, 1 month
measure: Change in Perceived Parental Approval of Underage Drinking from Baseline to 7 Months Post Intervention
timeFrame: baseline, 7 months
measure: Change in Perceived Parental Approval of Underage Drinking from Baseline to 12 Months Post Intervention
timeFrame: baseline, 12 months
measure: Change in Perceived Frequency of Parent Communication from Baseline to 1 Month Post Intervention
timeFrame: baseline, 1 month
measure: Change in Perceived Frequency of Parent Communication from Baseline to 7 Months Post Intervention
timeFrame: baseline, 7 months
measure: Change in Perceived Frequency of Parent Communication from Baseline to 12 Months Post Intervention
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Loyola Marymount
state: California
Study officials:
References: