Partnering to Enhance Emerging Adults' Response to Programs

NCT06115252 | Recruiting

• 2 other identifiers: O25-013-11R01AA030678-01
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use, Unspecified

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• BOLD response synchrony association with behavior change (past month alcohol use days)

  3 Months

• BOLD response synchrony association with behavior change (past month alcohol use days)

  6 Months

Study Arms (1)

Motivational Interviewing (MI)

EXPERIMENTAL

Behavioral: Motivational Interviewing (MI)

Interventions

Motivational Interviewing (MI) BEHAVIORAL

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.

Motivational Interviewing (MI)

Eligibility Criteria

• Age: 18 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UConn Health: lead
• University of Texas: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Texas Dallas

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sarah W. Feldstein Ewing, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

• Francesca Filbey, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Hudson, MCR

CONTACT

860-679-1037; khudson@uchc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 2, 2023
• Study Start: October 10, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: See details provided by the NIAAA Data Archive.

Locations

US (1)