ClinicalTrials.gg
RecruitingNCT06115252PEERUpdated Aug 25, 2026

Partnering to Enhance Emerging Adults' Response to Programs

An interventional study of Motivational Interviewing (MI) in Alcohol Use, Unspecified, sponsored by UConn Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by UConn Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Not applicable
Ages
18 Years to 24 Years
Sex
All
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Study 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.

02

Conditions studied

  • Alcohol Use, Unspecified

Browse trials for

03

In context

Alcohol Drinking

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's planned enrollment of 248 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 (e.g., unremovable metal on/in body, pregnant)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
248 participants (estimated)

Study arms

  • Experimental
    Motivational Interviewing (MI)

    Behavioral: Motivational Interviewing (MI)

Interventions

  • BehavioralMotivational 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 12 Months

Secondary outcomes

  1. 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.

    Time frame: 3 Months

  2. 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.

    Time frame: 6 Months

07

Study locations

1 of 1 sites recruiting
  • University of Texas Dallas
    Dallas, Texas 75235, United States
    Recruiting
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References and documents

Publications

  • Feldstein Ewing SW, Dash GF, Hudson KA, Hyun B, Yang M, Stahl L, Thomsen KR, Filbey FM. The Protocol for: Do peers enhance behavior change in group motivational interviewing? A translational clinical trial investigating brain synchrony in underage emerging adults during an fMRI hyperscanning task and association with alcohol use reductions. PLoS One. 2026 Jun 11;21(6):e0349575. doi: 10.1371/journal.pone.0349575. eCollection 2026. PubMed 42275392 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: 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.

Data sharing details ↗ · nda.nih.gov

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Mar 2028, 29 months after the start.

Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 29 months is above that.

Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2023
First posted
Nov 2, 2023
StartActual
Oct 10, 2025
Primary completionEst.
Mar 31, 2028
CompletionEst.
Mar 31, 2028
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06115252
Lead sponsor
UConn Health
Responsible party
Sarah Feldstein Ewing (Professor, UConn Health) — Principal investigator
First posted
Nov 2, 2023
Start date
Oct 10, 2025
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Aug 25, 2026

Study contacts

Karen Hudson, MCR
Contact
khudson@uchc.edu
860-679-1037
Sarah W. Feldstein Ewing, PhD
principal investigator · UConn Health
Francesca Filbey, PhD
principal investigator · University of Texas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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