NCT06861660

Brief Summary

This pilot randomized controlled trial (RCT) will evaluate both the feasibility and efficacy of Digitally Prompted Parenting (DPP), a text-message based parent intervention (tm-PBI) designed to prevent and reduce alcohol use among first-year college students. In this study, parents of incoming first-year students will receive risk-reducing text messages during the first 10 weeks of the Fall semester, which they can forward to their students. The trial uses a longitudinal design to compare drinking outcomes between students whose parents receive the DPP messages and those whose parents receive an established alcohol PBI (the active control condition). The investigators hypothesize that students in the DPP group will report lower levels of alcohol use and fewer alcohol-related consequences after the intervention compared to those in the active control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 27, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

March 1, 2025

Last Update Submit

April 15, 2026

Conditions

Outcome Measures

Primary Outcomes (10)

  • Change in Daily Drinking between Baseline and 3 Months

    Self-reported number of drinks consumed during an average week in the past 30 days.

    baseline, 3 months

  • Change in Daily Drinking between Baseline and 6 Months

    Self-reported number of drinks consumed during an average week in the past 30 days.

    baseline, 6 months

  • Change in Peak Drinking Occasion between Baseline and 3 Months

    Self-reported max number of drinks consumed on a single occasion in the past 30 days.

    baseline, 3 months

  • Change in Peak Drinking Occasion between Baseline and 6 Months

    Self-reported max number of drinks consumed on a single occasion in the past 30 days.

    baseline, 6 months

  • Change in Heavy Episodic Drinking Occasion between Baseline and 3 Months

    Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days.

    baseline, 3 months

  • Change in Heavy Episodic Drinking Occasion between Baseline and 6 Months

    Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days.

    baseline, 6 months

  • Change in Frequency of Intoxication Events between Baseline and 3 Months

    Self-reported number of times individuals reported drinking to intoxication in the past 30 days.

    baseline, 3 months

  • Change in Frequency of Intoxication Events between Baseline and 6 Months

    Self-reported number of times individuals reported drinking to intoxication in the past 30 days.

    baseline, 6 months

  • Change in Number of Alcohol-Related Consequences between Baseline and 3 Month

    Self-reported number of alcohol-related consequences in the past 30 days.

    baseline, 3 months

  • Change in Number of Alcohol-Related Consequences between Baseline and 6 Month

    Self-reported number of alcohol-related consequences in the past 30 days.

    baseline, 6 months

Study Arms (2)

Digitally Prompted Parenting

EXPERIMENTAL

Parents of participating first-year college students in this intervention arm will receive a series of prewritten text messages during the first 10 weeks of college. Parents can personalize these messages before sending them directly to their student, who is the study participant, with the goal of reducing alcohol-related risks.

Behavioral: Digitally Prompted Parenting

Active Control

ACTIVE COMPARATOR

Parents of participating first-year college students in this arm of the study will receive access to the Parent Handbook during the summer before matriculation and three booster emails that summarize its key points after matriculation.

Behavioral: Active Control

Interventions

Parents will receive an email invitation to sign up for Digitally Prompted Parenting, a text message-delivered PBI. Parents set up an account and input information about themselves and their student, which will customize the text messages they receive. Parents will receive at least two text prompts per week for the first 10 weeks of their student's first semester in college. These texts will (1) prompt parents to call their student to discuss the past week and week ahead, and (2) prompt parents to send an alcohol-specific risk reducing text to their student.

Digitally Prompted Parenting
Active ControlBEHAVIORAL

Parents will receive an email that explains the Parent Handbook intervention and includes a link to a website where the Handbook is embedded. They will also receive three booster emails summarizing the key points of the intervention. Parents can review both the Parent Handbook and the booster emails at their own pace.

Active Control

Eligibility Criteria

Age17 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Student is 17-20 years of age
  • Student is an LMU incoming first-year college student
  • Student has access to a cellular device capable of receiving text messages
  • Student's parent or legal guardian has an email address on file at LMU
  • Student's parent or legal guardian has a cellular device capable of receiving text messages
  • Student's parent or legal guardian received an invitation from the research team to participate
  • Student's parent or legal guardian signed up to access the assigned intervention
  • Student's parent or legal guardian is a resident of the United States
  • Informed consent (or assent, as applicable) is provided

You may not qualify if:

  • Student is not 17-20 years of age
  • Student is not an LMU incoming first-year college student
  • Student does not have access to a cellular device capable of receiving text messages
  • Student's parent or legal guardian does not have an email address on file at LMU
  • Student's parent or legal guardian does not have a cellular device capable of receiving text messages
  • Student's parent or legal guardian did not receive an invitation from the research team to participate
  • Student's parent or legal guardian did not sign up to access the assigned intervention
  • Student's parent or legal guardian is not a resident of the United States
  • Informed consent (or assent, as applicable) is not provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola Marymount

Los Angeles, California, 90045, United States

Location

MeSH Terms

Conditions

Underage Drinking

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study conditions are randomly assigned and the intervention delivery is automated. Senior members of the research team will have a record of the participants randomized to each condition, but the delivery of intervention content is automated. Junior members of the research team responsible for sending follow-up survey reminders will not be aware of participant condition assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2025

First Posted

March 6, 2025

Study Start

June 27, 2025

Primary Completion

March 16, 2026

Study Completion

March 16, 2026

Last Updated

April 16, 2026

Record last verified: 2025-07

Locations