Clinical trial NCT04247191: Parent Intervention to Reduce College Student Drinking and Consequences
Official title: Examining a Brief Parent Intervention to Reduce College Student Drinking and Consequences
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Underage Drinking
Driving Under the Influence
Drinking, Teen
Drinking, College
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-01-29
Enrollment: 2061
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group receives the PBI parent intervention; the second group receives the P-Chat intervention; the third group receive the P-Chat+ intervention; and the fourth group is an assessment-only control.
Primary purpose: PREVENTION

Brief 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).

Detailed 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 primary design is a four-arm randomized control trial with 4 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 four times: pre-intervention baseline and 3-month, 6-month, and 9-month follow-ups. To maximize the diversity of the sample, the investigators are oversampling for 30% racial/ethnic minorities, free of sample bias.

The continuation of the study is to assess the long-term effects of the parent interventions in the 4th (senior) year of college and one year later. Student participants will complete assessments twice: once during their senior year of college and once one year later after transitioning from college. Assessments will include online survey and the Alcohol Use Disorder (AUD) module of the Structured Clinical Interview for DSM-5 (SCID-5) interview at both time points.

Eligibility criteria: 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

Primary outcomes:
measure: Examine Changes in Alcohol Use
timeFrame: Baseline, 3 month, 6 month, 9 month, senior year college, 1-year post-college
measure: Examine Changes in Consequences of Alcohol Use
timeFrame: Senior year college, 1-year post-college
measure: Past year Alcohol Use Disorder (AUD)
timeFrame: Senior year college, 1-year post-college
Secondary outcomes:
measure: Examine Changes in Impaired Driving (IMPD) Behaviors
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Riding with Impaired Driver (RWID) Behaviors
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Consequences of Alcohol Use
timeFrame: Baseline, 3 month, 6 month, 9 month
Other outcomes:
measure: Examine Changes in Parental Rules about Underage Drinking (Permissiveness)
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Parental Communication
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Parental Communications
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Alcohol Use Motives
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Alcohol Use Expectancies
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month
measure: Examine Changes in Willingness to Drink Alcohol
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Peer Descriptive Norms
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in General Parental Practices
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Peer Injunctive Norms
timeFrame: Baseline, 3 month, 6 month, 9 month
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Robert Turrisi, PhD
role: PRINCIPAL_INVESTIGATOR
References: