Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05509218 |
| Other study ID # |
2022003299 |
| Secondary ID |
1R34AA029733-01A |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Brown University |
| Contact |
Jennifer E Merrill, PhD |
| Phone |
401-863-5165 |
| Email |
jennifer_merrill[@]brown.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators propose to examine mornings after drinking as an optimal time to provide
repeated, personalized feedback, with the goal of reducing hazardous drinking. Specifically,
the investigators will further develop and pilot test a novel theory-based personalized
feedback intervention (PFI) for heavy drinking young adults. Intervention strategies include
personalized feedback (e.g., feedback on prior night blood alcohol concentration,
consequences) contrasted with both drinking goals set at baseline and corrective normative
feedback (e.g., how last night's drinking compares to peers). Up to 170 participants (50%
non-college) will be randomized to one of three groups: PFI with monetary incentives for
daily surveys, PFI without monetary incentives, or survey assessment only. The investigators
will examine recruitment rates, retention rates, confirmation of intervention content
delivery/intake, response rates to daily surveys, data quality, and ratings of intervention
value. Investigators will test whether these indicators of engagement differ between those
who do and do not receive monetary incentives for daily surveys. Further, baseline,
post-test, and 3-month follow-up assessments will allow us to examine differences in drinking
behavior between PFI and control. The results of the proposed research will result in a novel
and scalable intervention for alcohol misuse among young adults, with potential to have an
important impact on the public health problem of high-risk drinking.
Description:
The investigators will recruit up to 170 participants for a small randomized controlled
trial. Participants will be randomized to four weeks of intervention with or without daily
incentives for completing surveys, or assessment-only control, to test feasibility,
acceptability, and initial evidence of efficacy.
1. Baseline assessment and orientation. An orientation meeting will be used to describe all
study procedures and obtain informed consent. If informed consent is obtained,
participants will then be given one week to complete a baseline survey (~30 minutes) on
their own time, using their own computers. Data needed to personalize the intervention
content will be collected during the baseline survey. Participants will be asked to
choose from a range of possible goal types (e.g., max drinks per drinking event, drinks
per week, weekly frequency of drinking, "skip goals", "delay goals", slow goals", "stop
goals"). These goals an be integrated/contrasted with subsequent self-reported behavior
on morning reports during the intervention period. After the baseline survey, a research
assistant (RA) will review study procedures.
2. Randomization. Randomization will occur following consent. The pilot randomized
controlled trial (RCT) will include three conditions (mobile PFI with daily incentive
for surveys, mobile PFI without daily incentives, assessment-only). PFI participants
(both groups) will also complete (1) orientation and participant training (as described
above), (2) four weeks of daily assessment and (3) intervention (as described below),
and (4) follow-up surveys.
3. Daily assessment. Daily assessment + feedback will begin on a Monday for all
participants. A link to a web-based morning survey will be sent at 7am, and it will
remain available until 2pm. When prior night alcohol use is endorsed, details will be
assessed via single item measures about the drinking event.
4. Personalized Feedback Reports. Following each daily survey on which a participant (in
PFI groups) indicates prior day drinking, personalized feedback will be provided on how
their most recent behavior (e.g., drinks last night, drinking days so far this week)
compare/contrast with personal goals. Participants will then choose whether to receive
additional feedback in any of 7 areas: blood alcohol concentration, high risk behaviors,
consequences of drinking, caloric intake, spending, how drinking compares to peers, and
safe drinking strategies. In addition to day-level feedback, an aggregate feedback
report on drinking patterns and related behaviors will be delivered twice, once at the
end of each 2-week period. At the end of the 2-week feedback report, participants in the
intervention groups will have the opportunity to update/add goals for the next 2 weeks,
given what they learned thus far about their personalized behavior-outcome links.
5. Follow-up surveys. At the end of four weeks, participants in all three groups will
complete a 30-minute online survey (post-intervention). The final 30-minute follow-up
will take place three months after the end of intervention (four months after baseline)
and will assess primary outcomes and mechanisms.
