Accountability Support Through Peer-Inspired Relationships and Engagement (ASPIRE) Trial (ASPIRE)

ASPIRE to Change: Leveraging Text Messaging Peer Support Coaching to Mitigate Hazardous Alcohol Consumption in Non-Collegiate Young Adults

This project aims to test the efficacy of a text message intervention, ASPIRE, designed to address cognitive and behavioral elements and modify exposure to peers that influence drinking behaviors. Young adults who are contemplating reducing their drinking will be recruited from a national sample and randomized to ASPIRE versus a text message intervention focused solely on cognitive and behavioral elements. We will measure effectiveness at 3, 6, and 12 months, study mechanisms driving behavior change, and identify which subgroups stand to benefit most.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Consumption
• Intervention / Treatment: Behavioral: A text message alcohol intervention focused on cognitive, behavioral, and peer influences; Behavioral: A text message alcohol intervention focused on cognitive and behavioral influences

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Suffoletto, MD, MS; Phone Number: 4129016892; Email: suffbp@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94306
      • Recruiting
      • Stanford University
      • Contact: Brian Suffoletto Associate Professor, MD, MS; Phone Number: (650)-723-5244; Email: aspirestudy@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-25 years (verified using date of birth)
• Lives in the U.S. (based on zip code)
• English reader (verified based on completing screen)
• 2+ days with ≧4 standard alcohol drinks for women or ≧5 standard alcohol drinks for men in past month
• Owns a mobile phone with SMS (verified by texting enrollment procedure)

Exclusion Criteria:

• Currently enrolled or past enrollment in a 4-year college
• Active military
• Pregnant or pregnancy plans in the next 12-months
• Prisoner status
• Current or planned treatment for alcohol or substance use disorder in next 12-months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A text message alcohol intervention focused on cognitive, behavioral, and peer influences	Behavioral: A text message alcohol intervention focused on cognitive, behavioral, and peer influences; Each Thursday and Sunday ASPIRE will conduct brief text message communication aimed at modifying cognitive (e.g.desire to get drunk), behavioral (e.g.alcohol consumption), and peer influences (e.g.peer pressure and support).
Active Comparator: A text message alcohol intervention focused on cognitive and behavioral influences	Behavioral: A text message alcohol intervention focused on cognitive and behavioral influences; Each Thursday and Sunday ASPIRE will conduct brief text message communication aimed at modifying cognitive (e.g. desire to get drunk) and behavioral (e.g. alcohol consumption) influences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Binge Drinking Days (BDD)	We define BDD as a day when a woman reports 4 or more standard drinks or a man reports 5 or more standard drinks, as this equates to the alcohol consumption that raises blood alcohol concentration to 0.08 g/dl or above.	3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Alcohol Consequences (NAC) Scale Score	We calculate the number of NAC using the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ). The B-YAACQ is a 24-item measure of alcohol-related problems that utilizes a dichotomous (present or absent) scoring format. Higher scores indicate both wider variety and more severe pattern of alcohol-related problems.	3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Brian Suffoletto, MD, Stanford University

Publications and helpful links

General Publications

• Kahler CW, Hustad J, Barnett NP, Strong DR, Borsari B. Validation of the 30-day version of the Brief Young Adult Alcohol Consequences Questionnaire for use in longitudinal studies. J Stud Alcohol Drugs. 2008 Jul;69(4):611-5. doi: 10.15288/jsad.2008.69.611.
• Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996 Sep;42(1):49-54. doi: 10.1016/0376-8716(96)01263-x.
• Rueger SY, Trela CJ, Palmeri M, King AC. Self-administered web-based timeline followback procedure for drinking and smoking behaviors in young adults. J Stud Alcohol Drugs. 2012 Sep;73(5):829-33. doi: 10.15288/jsad.2012.73.829.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: alcohol; young adults; text message; peers
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Anti-Infective Agents; Physiological Effects of Drugs; Central Nervous System Depressants; Anti-Infective Agents, Local; Ethanol
• Other Study ID Numbers: 76956; 1R01AA030986-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All test message and web-based data from baseline through 12-month followups will be uploaded to the data repository (the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA).
• IPD Sharing Time Frame: Data will be available within 1 year of study completion and available indefinitely.
• IPD Sharing Access Criteria: Individuals can request access to study data through the NIAAADA. If there are data from the trial not submitted to the NIAAADA , investigators can submit an abstract of their research question to the PI and study investigators for review. The written data request abstract will include the researcher's resume and qualifications (including a statement of any conflicts of interest), an outline of the analysis aims, analysis methods, variables requested, data to be analyzed, proposed product of the request (e.g., conference presentation, manuscript) and timeline for completion. The PIs and study investigators will review the data request abstract, and approve or decline the data request. Individuals whose data request is approved are asked to sign a confidentiality and data sharing agreement prior to receipt of any study data. The investigator making the request must obtain approval from their institution's IRB to conduct the proposed analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No