Trial Outcomes & Findings for Alcohol Intervention for First Year College Students (NCT NCT03750838)

NCT ID: NCT03750838

Last Updated: 2024-01-19

Results Overview

Item assessing whether participants found the study overall favorable as measured at 6-week follow-up.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-01-19

Participant Flow

Campus including in-person recruitment (e.g., tabling, distributing flyers at dorms), online recruitment, and sending student directory email invitations. Flyers advertising recruitment for the study were distributed at the on-campus orientation events and in student dorms with general, brief information about the study, links (URL and QR codes) to the screening survey, and the study's email address, and phone number. We recruited participants from June- August 2021.

Participants who were eligible, but did not complete the baseline survey were not fully enrolled and randomized to condition.

Participant milestones

Measure	Text Messaging Intervention Group Participants in the Text Message Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Message Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control Participants in the assessment only control condition completed all assessments on the same schedule as the Text Message Intervention group, but dot receive any text messages.
Overall Study STARTED	49	50
Overall Study 6 Week Follow-up	40	43
Overall Study 3 Month Follow-up	32	40
Overall Study 6 Month Follow-up	37	44
Overall Study COMPLETED	39	44
Overall Study NOT COMPLETED	10	6

Reasons for withdrawal

Measure	Text Messaging Intervention Group Participants in the Text Message Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Message Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control Participants in the assessment only control condition completed all assessments on the same schedule as the Text Message Intervention group, but dot receive any text messages.
Overall Study Lost to Follow-up	10	6

Baseline Characteristics

Alcohol Intervention for First Year College Students

Baseline characteristics by cohort

Measure	Text Messaging Intervention Group n=49 Participants Participants in the TM Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the TM Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Active Control n=50 Participants Participants in the attention only control condition will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups. Active Control: Participants will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=93 Participants	50 Participants n=4 Participants	99 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	18.06 years STANDARD_DEVIATION 0.24 • n=93 Participants	18.12 years STANDARD_DEVIATION 0.33 • n=4 Participants	18.09 years STANDARD_DEVIATION 0.29 • n=27 Participants
Sex: Female, Male Female	36 Participants n=93 Participants	36 Participants n=4 Participants	72 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=93 Participants	19 Participants n=4 Participants	35 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=93 Participants	30 Participants n=4 Participants	63 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants	5 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) White	23 Participants n=93 Participants	35 Participants n=4 Participants	58 Participants n=27 Participants
Race (NIH/OMB) More than one race	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Region of Enrollment United States	49 participants n=93 Participants	50 participants n=4 Participants	99 participants n=27 Participants
Current Non-Drinkers	42 Participants n=93 Participants	40 Participants n=4 Participants	82 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Acceptability data only collected from intervention group

Item assessing whether participants found the study overall favorable as measured at 6-week follow-up.

Outcome measures

Measure	Text Messaging Intervention Group n=40 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
Acceptability-Number of Participants Who Found the Study Overall Favorable	38 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Only those participants assigned to intervention were shown these items.

Item assessed by asking whether participants would recommend the study to other first-year college students

Outcome measures

Measure	Text Messaging Intervention Group n=40 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
Acceptability-proportion of Participants Who Would Recommend the Study	36 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Acceptability was only measured for those in text message intervention group

Text Message Rating Scale- assessed ratings of text message intervention content areas with a minimum value of 0 and a maximum value of 4 with higher numbers being a better outcome (i.e., more acceptable)

Outcome measures

Measure	Text Messaging Intervention Group n=24 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
Acceptability and Feasibility-ratings of Text Message Content Areas Substance free activities text messages	3.27 units on a scale Standard Deviation 0.16	—
Acceptability and Feasibility-ratings of Text Message Content Areas Image text messages	3.00 units on a scale Standard Deviation 0.47	—
Acceptability and Feasibility-ratings of Text Message Content Areas Norms text messages	2.72 units on a scale Standard Deviation 0.66	—
Acceptability and Feasibility-ratings of Text Message Content Areas Goals text messages	2.88 units on a scale Standard Deviation 0.33	—
Acceptability and Feasibility-ratings of Text Message Content Areas Protective Behavioral Strategies text messages	2.48 units on a scale Standard Deviation 0.14	—

SECONDARY outcome

Timeframe: 6 weeks

Number of participants who initiated drinking since the baseline assessment

Outcome measures

Measure	Text Messaging Intervention Group n=40 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control n=43 Participants Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 months

Number of participants who initiated drinking at the 3 month assessment since the 6 week assessment

Outcome measures

Measure	Text Messaging Intervention Group n=32 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control n=40 Participants Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 months

Number of participants who initiated alcohol use at 6 month assessment since the 3 month assessment

Outcome measures

Measure	Text Messaging Intervention Group n=37 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control n=44 Participants Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 9 months

Number of participants who initiated drinking at 9 month assessment since the 6 month assessment

Outcome measures

Measure	Text Messaging Intervention Group n=39 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control n=44 Participants Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)	6 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Mean and SD of number of drinks consumed each week using the Daily Drinking Questionnaire

Number of drinks consumed each week as measured at 6 week assessment

Outcome measures

Measure	Text Messaging Intervention Group n=40 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control n=43 Participants Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
6 Week Alcohol Quantity (Number of Drinks Per Week)	1.89 drinks per week Standard Deviation 2.98	2.03 drinks per week Standard Deviation 3.34

SECONDARY outcome

Timeframe: 3 months

Population: Mean and SD of number of drinks consumed each week using the Daily Drinking Questionnaire

Number of drinks consumed each week as measured at 3 month assessment

Outcome measures

Measure	Text Messaging Intervention Group n=32 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control n=40 Participants Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
3 Month Alcohol Quantity (Number of Drinks)	1.52 drinks per week Standard Deviation 2.38	2.03 drinks per week Standard Deviation 2.78

SECONDARY outcome

Timeframe: 6 months

Population: Mean and SD of number of drinks consumed each week using the Daily Drinking Questionnaire

Number of drinks consumed each week as measured at 6 month assessment

Outcome measures

Measure	Text Messaging Intervention Group n=37 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control n=44 Participants Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)	1.48 drinks per week Standard Deviation 2.62	1.67 drinks per week Standard Deviation 3.39

SECONDARY outcome

Timeframe: 9 months

Population: Mean and SD of number of drinks consumed each week using the Daily Drinking Questionnaire

Number of drinks consumed each week as measured at 9 month assessment

Outcome measures

Measure	Text Messaging Intervention Group n=39 Participants Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful. Text Messaging Intervention: The content for the Text Messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.	Assessment Only Control n=44 Participants Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.
9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)	1.46 drinks per week Standard Deviation 2.74	1.21 drinks per week Standard Deviation 2.20

Adverse Events

Text Messaging Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Assessment Only Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dana Litt

University of North Texas Health Science Center

Phone: 817-735-5453

Email: dana.litt@unthsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place