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

NCT06617702 | Active Not Recruiting DMC

• 2 other identifiers: 769561R01AA030986-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Consumption

Keywords

alcohol; text message; young adults; peers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Negative Alcohol Consequences (NAC) Scale Score

  3, 6 and 12 months

Study Arms (2)

A text message alcohol intervention focused on cognitive, behavioral, and peer influences

EXPERIMENTAL

Behavioral: A text message alcohol intervention focused on cognitive, behavioral, and peer influences

A text message alcohol intervention focused on cognitive and behavioral influences

ACTIVE COMPARATOR

Behavioral: A text message alcohol intervention focused on cognitive and behavioral influences

Interventions

A text message alcohol intervention focused on cognitive and behavioral influences BEHAVIORAL

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.

A text message alcohol intervention focused on cognitive and behavioral influences

A text message alcohol intervention focused on cognitive, behavioral, and peer influences BEHAVIORAL

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).

A text message alcohol intervention focused on cognitive, behavioral, and peer influences

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• + 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94306, United States

Location

Related Publications (3)

• 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.

  PMID: 18612578 BACKGROUND

• 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.

  PMID: 8889403 BACKGROUND

• 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.

  PMID: 22846247 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Brian Suffoletto, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: September 27, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 1 year of study completion and available indefinitely.
• 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.

Locations

US (1)