Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04105725 |
| Other study ID # |
4324 |
| Secondary ID |
1F31AA026486-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2018 |
| Est. completion date |
July 31, 2020 |
Study information
| Verified date |
May 2022 |
| Source |
University of Memphis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to evaluate a text-message delivered approach for improving
college adjustment and experience and reducing risky alcohol use in young adult college
students. The study compares a text-message delivered brief motivational intervention for
reducing alcohol use and increasing engagement in alcohol-free activities, to text-message
delivered alcohol and nutrition education sessions. The investigators predict that
individuals who receive the brief motivational intervention will report less alcohol use and
fewer related problems 3 months following the intervention compared to those who receive the
education sessions. The investigators also expect that these individuals will report greater
engagement in alcohol-free activities compared to those who receive the education sessions.
Description:
The proposed project will develop and empirically evaluate a mobile-based alcohol brief
intervention and substance-free activity session. To do this, study personnel will develop
and systematically evaluate an intervention that includes efficacious elements of brief
alcohol interventions along with personalized feedback. Intervention elements will be
delivered remotely via personalized web-based feedback and text-messages. The proposed
project will evaluate the efficacy of the mobile-based brief alcohol intervention compared to
mobile-based alcohol and nutrition education in the context of a randomized pilot trial.
This research will be divided into two stages: Stage 1, the screening stage, and Stage 2, the
randomized pilot trial stage. During the screening stage, participants will be recruited and
screened for eligibility to participate in Stage 2. The randomized controlled trial stage
(stage 2) will test the feasibility and efficacy of a mobile-based BMI + SFAS in the context
of a two-group experimental design. All students (N = 100) will complete a baseline
assessment and will then be randomly assigned to either receive a mobile-based BMI + SFAS, or
mobile-based alcohol and nutrition education. Each group will receive 4 weeks of booster
contact (1 booster session per week) on material from their respective study condition.
Outcomes will be assessed after the fourth booster session and at a 3-month follow-up.
Participants will complete a brief screening survey via the SONA system or through a secure
web-link sent via email or posted in flyers to identify those students who might be eligible
to participate in the study. In order to be contacted about the clinical trial, respondents
will be asked to provide contact information. Ads and flyers will also include study contact
information for interested respondents/participants to contact study staff directly and
screen for eligibility.
If the participant meets eligibility criteria, the researcher will speak with the participant
via phone call to explain the project procedures and confidentiality in more detail, and
allow the participant the opportunity to ask any questions they may have about the study.
Text messaging and email may also be used as methods to communicate with participants who
meet the eligibility criteria and will be used as the primary method of communication if the
student prefers. Participants will be informed that the study is designed to learn more about
college students' lifestyle and health behaviors and that the study will involve random
assignment to one of two treatment conditions, along with 4 booster sessions by text-message,
a post-intervention survey immediately following the 4th booster session, and a survey
follow-up three months after their last booster session. If the participant expresses
interest in the study, the study administrator will invite them to participate in further
phases of the study. If students do not meet the eligibility criteria at the time of
screening, but indicate drinking in the past 6-months, they may be contacted later and
re-screened via phone, text message or email and then enrolled if interested in the study.
Eligible and interested individuals will remotely read and e-sign the consent form, provide
contact information, and complete the initial baseline assessment via a secure web-link.
All self-report measures will be completed by the participant via a secure, web-based survey.
Prior to completing baseline measures, participants will be provided with a consent form and
will be informed of the study's purpose, risks, benefits, compensation, and all other
pertinent study details. Participants will be provided with a phone number and email address
should they have questions and will also be informed in the consent that they can discontinue
the study at any time. If participants choose not to e-sign the consent form or decide not to
participate in the study at any time, they will be provided with information about college
student alcohol misuse on websites, hotlines, and local resources to learn more about their
drinking if they are interested. The remote web-based assessment will last approximately 30
minutes. After completing the assessment, participants will be randomized to either a) the
mobile-based BMI+SFAS (mBMI+SFAS); or b) mobile-based alcohol and nutrition education (mA+NE)
(both described below). Immediately following the baseline assessment and random assignment,
participants will take part in a 60-minute session of either the mobile BMI or mobile Alcohol
Education. Later the same week, participants will take part in either one 60-minute session
of the mobile SFAS or mobile Nutrition Education. The interventionist conducting the mobile
BMI or Alcohol Education earlier in the week will also conduct the mobile SFAS or Nutrition
Education, respectively, as well as all booster contact. A brief 3-item survey will be
administered immediately following the mobile SFAS or Nutrition Education session that will
solicit initial impressions and feedback on these respective sessions.
Booster contact will take place once a week for four weeks for approximately 20 minutes.
Booster contact for the mBMI+SFAS group will also collect information on past week time
allocation, level of discounting of future monetary rewards (delay discounting), and the
subjective reward value of alcohol, which are associated with problematic alcohol use. Upon
completion of the booster contact, participants will complete a 5-week assessment survey via
secure web link. The post-intervention survey will collect information on the participants'
experiences with the mobile-based interventions and will solicit feedback about the
interventions. They will then be thanked for their participation and reminded of their
3-month follow-up appointment.
All participants will be asked to download on to their smartphone or personal computer a
secure messaging web app called Babelnet (https://www.babelnet.com/en/). Babelnet is free to
download and use, and study personnel will assist participants in the download and use of the
app. Participants will be assigned a username that will be similar to their study
identification number and a password that will be saved in a secure, password protected file
only accessible to study personnel. In the event a participant has forgotten or lost their
Babelnet login information, they may contact study personnel to retrieve it and log in
securely. Messages sent through Babelnet are heavily encrypted by the app. However, study
personnel will record (via screenshot or copy-and-paste) the text conversations to facilitate
later communication and for intervention supervisory, as well as fidelity, purposes. These
recordings will be saved on a secure server in a password protected shared drive that is
accessible only to study personnel.
Three months post-booster completion, participants will be asked to remotely complete a
web-based follow-up self-report assessment battery. The follow-up will assess the impact of
the interventions on attitudes and behaviors toward alcohol use, as well as patterns of
alcohol-related problems and drinking levels, and will last approximately 30 minutes.
After the 3-month assessment, participants will be given the option to complete any of the
intervention sessions that they did not complete as a part of the study or to complete a
session for a second time.
