Alcohol Use, UnspecifiedPEERNCT06115252
Partnering to Enhance Emerging Adults' Response to Programs
A study testing Motivational Interviewing (MI) in people with Alcohol Use, Unspecified, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Unspecified
- What is being tested?
- Motivational Interviewing (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- within the specified age range
- agree to be contacted for the 3, 6, and 12 month follow ups
- provide fully informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Dallas
Dallas, Texas, 75235
Cameron Sullins, BS, 972-883-3726, Cameron.Sullins@UTDallas.edu
Francesca Filbey, PhD
About this study
Official title: 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.
- Conditions
- Alcohol Use, Unspecified
- Being tested
- Motivational Interviewing (MI)
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Not described Receives: Behavioral: Motivational Interviewing (MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Months
Secondary outcomes (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 3 month follow up.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start10 Oct 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sarah Feldstein Ewing, UConn Health
- Investigators
- Sarah W. Feldstein Ewing, PhD, Principal investigator, UConn HealthFrancesca Filbey, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115252
- Sponsor's protocol ID
- O25-013-1
- Other IDs
- 1R01AA030678-01
- Acronym
- PEER
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnering to Enhance Emerging Adults' Response to Programs (PEER)
- ClinicalTrials.gov ID
- NCT06115252
- Acronym / sponsor ID
- PEER / O25-013-1
- Conditions
- Alcohol Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- University of Texas, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Behavioral: Motivational Interviewing (MI) |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- within the specified age range
- agree to be contacted for the 3, 6, and 12 month follow ups
- provide fully informed consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Motivational Interviewing (MI) |
Primary outcome
Blood oxygen level dependent (BOLD) response synchrony
Time frame: Baseline
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.
BOLD response synchrony association with behavior change (past month alcohol use days)
Time frame: 12 Months
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.
2 secondary outcomes
BOLD response synchrony association with behavior change (past month alcohol use days)
Time frame: 3 Months
BOLD response synchrony association with behavior change (past month alcohol use days)
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 42275392Feldstein 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah W. Feldstein Ewing, PhD principal investigator
UConn Health
Francesca Filbey, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (MI) in people with Alcohol Use, Unspecified, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Hudson, MCR (860-679-1037, khudson@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygen level dependent (BOLD) response synchrony (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.