A Randomized Trial of Letting Go and Staying Connected, an Interactive Parenting Intervention to Reduce Risky Behaviors Among Students
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Washington State University
- Enrollment
- 910
- Locations
- 1
- Primary Endpoint
- Change over time in 30-day alcohol use
Study Overview
Brief Summary
Alcohol abuse is the leading cause of death and serious injury among college students, and students also experience significant harms from other types of substance misuse and risk behaviors. The proposed project is a randomized controlled trials that will test the protective effects of Letting Go and Staying Connected, a handbook for parents of students who are transitioning for the first time from home to college, the time when students are at greatest risk. The handbook encourages parent skill development and good management of their student's new independence, providing a clear framework to guide them in parenting at this stage. Targeted outcomes include reduction of substance use and risk behaviors. The primary hypothesis is that students who are in one of the two handbook conditions with their parents will report lower substance use and risk behaviors in the two years after college entry.
Detailed Description
This is a randomized controlled trial (RCT) with two experimental conditions (Handbook and Handbook+) and a control. Each condition will be composed of 450 student/parent dyads, about half in Cohort 1 and half in Cohort 2. Participants will be recruited from the incoming freshman classes at Washington State University in 2017 and 2018 by the Social Development Research Group (SDRG) at University of Washington. Parents in both experimental conditions will receive a handbook in the summer before school starts. The handbook contains suggested conversation starters, checklists, and activities to be completed by the parent/student dyad. Activities are based in theory of social and emotional development and designed to address risk and protective factors for this age group as they transition to living independently from parents. Handbook plus parents will additionally receive text messages periodically throughout the fall and spring semesters, some of which are designed to let them know about major university events (e.g. home football games) which are known to be high-risk periods. Each cohort will be followed for two years. Parents complete surveys at baseline (spring before students starts) and in fall semester. Students complete surveys at baseline and each semester for their first two years at school.
Specific Aims of the project are as follows:
Aim 1: Test the efficacy of Letting Go and Staying Connected, a theoretically guided, developmentally targeted, and empirically supported handbook intervention for parents of students transitioning to college. The investigators hypothesize that students in the Handbook conditions will engage in fewer risk behaviors, including initiation, use, and abuse of substances (alcohol, marijuana, opiates, and prescription stimulants) and HIV/sex risk behaviors. As a result, Handbook students will also report fewer physical, emotional, social, and academic harms. The investigators will test a control condition vs. a "Handbook Only" and a "Handbook Plus" condition (an enhanced version of the intervention that adds strategically-timed Short Message Service and/or emails designed to increase utilization of the intervention).
Aim 2: Test theoretically specified mediational pathways between Handbook utilization and the expected intervention changes in risk behaviors/associated harms. The investigators expect that the effect of the Handbook on student outcomes will be mediated by both parent and student behaviors, as described in the following path: 1) Parent engagement in and use of the intervention 2) Parent practices in family management, autonomy support, and emotional support 3) Students' perceived rewards for healthy behaviors 4) Healthy connections with parents and peers 5) Healthy beliefs and clear standards leading to 6) Reduced substance use and sex risk behaviors; increased academic performance.
Aim 3: Identify specific attributes of parent-student communication that predict and covary with student substance use and HIV/sex risk behaviors. Early in their first semester, the investigators will survey students intensively over 2 periods of 7 days to learn about their daily communication with parents and their daily risk behaviors. Because little is known about parent-student communication at this developmental stage, the investigators will conduct descriptive and exploratory analyses on the content, emotional tone, timing, duration, mode, and frequency of parents' communication with their students and examine how those aspects of communication relate to student risk behaviors and associated harms at both a between-person and a within-person level.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 22 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Students at least 17 and under 22 years of age who are attending college for first time
Exclusion Criteria
- •Non-English speaking students/parents
- •Students whose primary residence is outside the U.S.
- •Students who will be living at home rather than at school
Arms & Interventions
Handbook condition
Parents in this condition receive a handbook designed for parents of first-year college-going students the summer before school starts
Intervention: Handbook condition (Behavioral)
Handbook plus condition
Parents in this condition receive a handbook designed for parents of first-year college-going students the summer before school starts plus a series of text messages during students' first year of college
Intervention: Handbook plus condition (Behavioral)
Control
Parents receive treatment as usual of incoming university student parents
Outcomes
Primary Outcomes
Change over time in 30-day alcohol use
Time Frame: At baseline students are asked if about 30-day alcohol use. This same question is then asked 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.
We expect to see differences between conditions in amount of 30-day (past-month) alcohol use from baseline through 104 weeks after baseline. Consistent with our analysis profile, we will examine change over time in 30-day alcohol use for each arm of the study and test for differences across conditions in the slope of change.
Secondary Outcomes
- Past 30-day frequency of illicit drug use(At baseline students are asked if they have used any illicit drugs during the 30 days preceding the survey. This same question is then asked at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Continuous matriculation at university during first two years(End of each semester during first two years of school, at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline)
- Lifetime marijuana use(At baseline students are asked if they have ever used marijuana. This same question is then asked 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Past 30-day frequency of risky sexual behavior(At baseline students are asked if they have engaged in any risky sexual behaviors during the 30 days preceding the survey. This same question is then asked at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Past 30-day frequency of marijuana use(At baseline students are asked if they have used any marijuana during the 30 days preceding the survey. This same question is then asked at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Past 30-day frequency of prescription drug misuse(At baseline students are asked if they have used any prescription drugs in a manner other than that prescribed during the 30 days preceding the survey. This same question is then asked at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Lifetime prescription drug misuse(At baseline students are asked if they have ever used prescription drugs in a manner other than that prescribed. This same question is then asked 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Cumulative grade point average(End of each semester during first two years of school, at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline)
- Lifetime alcohol use (Cohort 2 only)(At baseline students are asked if they have ever used any alcohol. This same question is then asked at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Rutgers Alcohol Problem Index (White & LaBouvie, 1989)(At baseline students are asked if about problems experienced due to alcohol over the past month; they are asked again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Sexual Consequences Index (National College Health Assessment, 2016)(Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Lifetime illicit drug use(At baseline students are asked if they have ever used illicit drugs. This same question is then asked 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Lifetime risky sexual behaviors(At baseline students are asked if they have ever engaged in risky sexual behaviors. This same question is then asked 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Past two-week heavy episodic drinking episodes(At baseline students are asked if they have had more than 4 (for women) or 5 (for me) drinks of alcohol in one sitting during the past two weeks. This same question is then asked 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
- Marijuana Consequences Index (Lee, 2016)(At baseline students are asked if about problems experienced due to marijuana over the past month; they are asked again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.)
Investigators
Laura Griner Hill
Professor
Washington State University