Partnering to Enhance Emerging Adults' Response to Programs (PEER)

Partnering to Enhance Emerging Adults' Response to Programs (PEER)

The goal of this clinical trial (CT) is to learn more about emerging adults' and their peers. Here, we will see how co-participating with a peer in health program might impact brain and behavior change over time.

Eligible youth will be invited to come in for a "Participation Day," during which they and a peer will independently complete questionnaires. With a peer, they will then complete a short health program, and undergo a brain scan (fMRI) while completing activities. Our study team will reach out to each participant individually again 3, 6, and 12 months later to learn about health behaviors over time.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use, Unspecified
• Intervention / Treatment: Behavioral: Motivational Interviewing (MI)

• Study Type: Interventional
• Enrollment (Estimated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Hudson, MCR; Phone Number: 860-679-1037; Email: khudson@uchc.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • University of Texas Dallas
      • Contact: Cameron Sullins, BS; Phone Number: 972-883-3726; Email: Cameron.Sullins@UTDallas.edu
      • Principal Investigator: Francesca Filbey, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• within the specified age range
• agree to be contacted for the 3, 6, and 12 month follow ups
• provide fully informed consent

Exclusion Criteria:

• left-handed
• evidence of brain injury/illness and/or neurological, neurodevelopmental disorder including psychosis and related medications (e.g., antipsychotics; neuroleptics)
• loss of consciousness ≥ 2 minutes
• other fMRI contraindications (e.g., unremovable metal on/in body, pregnant)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Motivational Interviewing (MI)

Behavioral: Motivational Interviewing (MI); Motivational interviewing with peer dyads starts with an open-ended exploration of the dyad's hazardous drinking behavior via personal stories about alcohol use. It includes a values clarification task and age-matched norms along with personalized feedback regarding the dyad's alcohol use. The goal of the session is to engage the dyad in a thoughtful conversation about drinking and the implications it may have on their lives, with an eye to bolstering and supporting inherent drive for behavior change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood oxygen level dependent (BOLD) response synchrony	Mean BOLD time series will be obtained for each region of interest (ROI) during peer-directed change talk trials and temporally aligned across dyad participants. Inter-brain synchrony will be quantified using z-transformed GLM β-weights within ROIs between the BOLD time series of dyad members.	Baseline
BOLD response synchrony association with behavior change (past month alcohol use days)	Pearson correlation coefficients (r) of Primary Outcome #1 (ROI z-scores representing BOLD response synchrony) with individual Timeline Followback (TLFB) past month drinking days at 12 month follow up.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD response synchrony association with behavior change (past month alcohol use days)	Pearson correlation coefficients (r) of Primary Outcome #1 (ROI z-scores representing BOLD response synchrony) with individual Timeline Followback (TLFB) past month drinking days at 3 month follow up.	3 Months
BOLD response synchrony association with behavior change (past month alcohol use days)	Pearson correlation coefficients (r) of Primary Outcome #1 (ROI z-scores representing BOLD response synchrony) with individual Timeline Followback (TLFB) past month drinking days at 6 month follow up.	6 Months

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Texas
• Investigators: Principal Investigator: Sarah W. Feldstein Ewing, PhD, UConn Health; Principal Investigator: Francesca Filbey, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Alcohol Drinking; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: O25-013-1; 1R01AA030678-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will submit and share data with the NIAAA Data Archive, a data repository housed within the NIMH Data Archive, and will follow the guidelines described in NOT-AA-23-002.
• IPD Sharing Time Frame: Data will be submitted on or before the NDA submission due dates and maintained for the duration required by NIAAA Data Archive Data Sharing Plan.
• IPD Sharing Access Criteria: See details provided by the NIAAA Data Archive.
• 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