Parent Intervention to Reduce College Student Drinking and Consequences

Driving Under the Influence Clinical Trial

Official title:

Examining a Brief Parent Intervention to Reduce College Student Drinking and Consequences

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04247191
• Other study ID #: 2R01AA012529-14
• Secondary ID: R01AA012529
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

College students' alcohol use continues to be a major public health problem. Among the many consequences of this risky behavior are impaired driving and impaired passenger fatalities. Both college health administrators and parents have requested parent-based interventions (PBIs), and parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the PBI that includes additional content for parents to establish clear lines of communication around the important topic of permissiveness (referred to as P-Chat).

Description:

High-risk drinking and the associated consequences continue to be significant problems among college students. Among the many consequences of this risky behavior are impaired driving and impaired passenger fatalities. These concerns are further magnified by reports showing: 1) younger drivers are overrepresented in fatal crashes involving impaired drivers; 2)~1 in 6 fatalities are passengers (riders with the impaired drivers; RWID); and 3) although over 1.3 million drivers in the U.S. are arrested for impaired driving annually, they only represent 1% of the estimated 121 million self-reported episodes of impaired driving each year. Despite the benefits noted for the PBI, the investigators' recent NIAAA funded research examining parenting throughout college identified associations between specific parenting behaviors and risky drinking and consequences among students that are not adequately addressed. This research revealed several important trends: 1) many parents allow their teens to drink alcohol in an attempt to take the mystery away and provide opportunities to teach them safer drinking practices; 2) this "parental permissiveness" toward underage drinking, even though it was intended to be protective by parents, had the opposite effect and was significantly associated with increased risky drinking and consequences throughout college even when taking into account other critical factors (e.g., peer norms); 3) even small increases in parental permissiveness translated into students experiencing 4-5 more consequences per year; and 4) the effects of this parental permissiveness was not attenuated by other positive parenting behaviors (e.g., communication, monitoring, modeling). In response to these findings and the initial pilot study showing parents were initially reluctant to change their permissiveness when simply provided with the information about how it was associated with risky student drinking, the investigators embarked on a new endeavor in college student parent intervention research. The investigators developed a brief 15-20 minute intervention (P-Chat) that uses principles of Motivational Interviewing (MI) to reduce defensiveness and modify parents' motives (and behaviors) to change parental permissiveness, and in turn, reduce students' risky drinking and consequences. The investigators have also conducted a pilot randomized controlled trial (RCT) study to demonstrate ability to implement the P-Chat with fidelity; modify parents' willingness to change; and change parents' permissive behaviors. The pilot data provides evidence that the P-Chat intervention has the potential to substantially improve the public health impact of PBIs. The proposed research will examine the P-Chat as a stand-alone intervention and also as an add-on in combination with the original PBI to evaluate the best practice for implementation in a RCT using a rigorous study design. The design is a four-arm randomized control trial with 5 waves of data collection (P-Chat, P-Chat+, PBI Only, and assessment only control). The study will enroll an ethnically diverse sample of 900 parent-student dyads. Students will complete assessments of all the primary, secondary, and tertiary outcomes at five times: pre-intervention baseline and 3-month, 6-month, 9-month, and 12-month follow-ups. To maximize the diversity of the sample, the investigators are oversampling for 30% racial/ethnic minorities, free of sample bias.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2025
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 19 Years

Eligibility

Inclusion Criteria:

• Parent and teen both consent and complete baseline (forming a dyad testing unit);

Exclusion Criteria:

• Outside of the teen age range; both parent and teen do not consent and complete baseline

Related Conditions & MeSH terms

• Alcohol Drinking in College
• Drinking, College
• Drinking, Teen
• Driving Under the Influence
• Underage Drinking

Intervention

Behavioral:
• P-Chat
The P-Chat is a brief individually delivered intervention based on the principles of Motivational Interviewing (MI) and focuses on increasing parents' motivation to reduce permissiveness toward underage alcohol use while reducing defensiveness and barriers to implementing these rules with their teen.
• PBI
The PBI is currently a model prevention resource at NIAAA's College Alcohol Intervention Matrix and the research was discussed in the most recent Surgeon General's Report as one of the two prevention approaches that met the rigorous criteria to be considered "efficacious". The first section of the PBI provides an introduction to the problem of substance use. The second section focuses on specific skill building strategies that parents can use to improve communication channels with their teen. Third, is a section that addresses peer influence and provides strategies for developing assertiveness. The fourth section is an in-depth discussion of underage drinking, physiological and psychological effects, mixing alcohol with other drugs, motives for why students drink and don't drink, warning signs, risky binge-type drinking, impaired driving, riding with impaired drivers, alcohol and sexual assault, and how to communicate about parents' experiences when they were young.
• P-Chat+
The P-Chat+ is a combination of the P-Chat and PBI described above. Parents in this arm of the study will receive both interventions.

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Penn State University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Examine Changes in Parental Rules about Underage Drinking (Permissiveness)	Adapted from measures by Van Der Vorst et al. (2006), parental permissiveness of underage drinking will be assessed using six items (e.g., I am allowed to drink alcohol on special occasions), based on level of agreement on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree.	Baseline, 3 month, 6 month, 9 month, 12 month
Other	Examine Changes in Parental Communication	Parental communication about alcohol use, IMPD, and RWID will be assessed separately for mothers and fathers. Participants will be asked whether their parent discussed these topics (yes/no) with them within the past three months. Items include topics such as "the importance of not being pressured to drink to fit it" and "the health reasons why you should not be allowed to get drunk once in a while".	Baseline, 3 month, 6 month, 9 month, 12 month
Other	Examine Changes in Parental Communications	General Communication (e.g., my mother/father is there for me when I want to talk) will be assessed separately for mothers and fathers based on level of agreement on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree.	Baseline, 3 month, 6 month, 9 month, 12 month
Other	Examine Changes in Alcohol Use Motives	Motives will be assessed for using alcohol (e.g., to be sociable; Cooper, 1994). Responses will be recorded using 5-point scale ranging from (1) almost never/never to (5) almost always/always.	Baseline, 3 month, 6 month, 9 month, 12 month
Other	Examine Changes in Alcohol Use Expectancies	Expectancies for using alcohol (e.g., I will feel badly about myself because of my drinking) will be measured. Responses will be recorded using 7-point scale ranging from (1) strongly disagree to (7) strongly agree.	Baseline, 3 month, 6 month, 9 month, 12 month
Other	Examine Changes in Willingness to Drink Alcohol	Response options for willingness items will be on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree. Willingness to drink will be measured with three items assessing participants' willingness to 1) drink 1-2 drinks in 2 hours; 2) drink 3-4 drinks in 2 hours; 3) drink 5+ drinks in 2 hours.	Baseline, 3 month, 6 month, 9 month, 12 month
Other	Examine Changes in Peer Descriptive Norms	Perceived peer descriptive norms of drinking will be measured using the Daily Drinking Questionnaire (DDQ; Collins, Parks, & Marlatt, 1985) by assessing how much alcohol, on average, participants' closest friends drink each day of the week.	Baseline, 3 month, 6 month, 9 month, 12 month
Other	Examine Changes in General Parental Practices	General Parenting Practices (e.g., if I had a personal problem I could ask my mother/father for help) will be assessed separately for mothers and fathers based on level of agreement on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree.	Baseline, 3 month, 6 month, 9 month, 12 month
Other	Examine Changes in Peer Injunctive Norms	Perceived peer injunctive norms will be measured by indicating the level of approval participants' closest friends would have from a list of items (e.g., drinking alcohol every weekend) on a 7-point scale ranging from (1) strongly disapprove to (7) strongly approve.	Baseline, 3 month, 6 month, 9 month, 12 month
Primary	Examine Changes in Alcohol Use	A standard drink definition will be provided, indicating that a standard drink consists of 12 oz. of beer or wine cooler, 8.5 oz. of malt liquor, 4 oz. of wine, or 1.5 oz. of hard liquor. Using the Timeline Followback (TLFB; Sobell & Sobell, 1996) participants will indicate how many drinks they consumed on each day of the past three months. For days alcohol was consumed, participants will also note the number of hours spent drinking.	Baseline, 3 month, 6 month, 9 month, 12 month
Secondary	Examine Changes in Impaired Driving (IMPD) Behaviors	Using the TLFB calendar, participants will indicate whether they drove a vehicle after using alcohol(Yes/No).	Baseline, 3 month, 6 month, 9 month, 12 month
Secondary	Examine Changes in Riding with Impaired Driver (RWID) Behaviors	Using the TLFB calendar, participants will indicate whether they rode in a vehicle with a driver that had been drinking (Yes/No).	Baseline, 3 month, 6 month, 9 month, 12 month
Secondary	Examine Changes in Consequences of Alcohol Use	Alcohol-related consequences (e.g., said or done embarrassing things, blackout) from the past three months will be measured using the established Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Read, Kahler, Strong, & Colder, 2006). Response options will be measured on a 7-point scale ranging from (0) no, not in the past year to (6) 11 or more times in the past year.	Baseline, 3 month, 6 month, 9 month, 12 month