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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06115252
Other study ID # R01AA030678
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date February 28, 2028

Study information

Verified date May 2024
Source University of Rhode Island
Contact Karen Hudson, MCR
Phone 401-874-4239
Email hudsonk@uri.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 248
Est. completion date February 28, 2028
Est. primary completion date February 28, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Rhode Island University of Texas

Outcome

Type Measure Description Time frame Safety issue
Primary Blood oxygen level dependent (BOLD) response to self-talk Examine changes in brain activation (BOLD response) as a result of participant's own in-session language Baseline
Primary Blood oxygen level dependent (BOLD) response to dyadic exchange Examine changes in brain activation (BOLD response) as a result of participants' dyadic in-session language Baseline
Primary Pearson correlation of self-talk BOLD response percent signal change with youth health behavior assessed with the Timeline Followback Association of brain response from Outcome 1 with Timeline Followback change over time 3-, 6-, and 12-months
Primary Pearson correlation of dyadic exchange BOLD response percent signal change with youth health behavior assessed with the Timeline Followback Association of brain response from Outcome 2 with Timeline Followback change over time 3-, 6-, and 12-months
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