NCT03227809

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
910

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

3.1 years

First QC Date

July 3, 2017

Last Update Submit

May 18, 2020

Conditions

Keywords

College student risk behavior preventionSubstance useAlcoholMarijuanaIllicit drugsPrescription drug misuseRisky sexual behaviors

Outcome Measures

Primary Outcomes (1)

  • Change over time in 30-day alcohol use

    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.

    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.

Secondary Outcomes (15)

  • 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

  • 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

  • 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.

  • 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.

  • 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.

  • +10 more secondary outcomes

Other Outcomes (13)

  • Reinforcement of positive behaviors by parents (Aldeis & Afifi, 2013)

    Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.

  • Peer rewards for antisocial behaviors (Arthur, Hawkins et al., 2002)

    Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.

  • Parental attitudes favorable to drug use (Arthur, Hawkins et al., 2002)

    Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.

  • +10 more other outcomes

Study Arms (3)

Handbook condition

EXPERIMENTAL

Parents in this condition receive a handbook designed for parents of first-year college-going students the summer before school starts

Behavioral: Handbook condition

Handbook plus condition

EXPERIMENTAL

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

Behavioral: Handbook plus condition

Control

NO INTERVENTION

Parents receive treatment as usual of incoming university student parents

Interventions

Parents of first-year university students receive parent handbook summer before start of university. Handbook contains suggestions for activities and conversations parents can conduct with students.

Also known as: First Years Away from Home
Handbook condition

Parents of first-year university students receive parent handbook summer before start of university. Handbook contains suggestions for activities and conversations parents can conduct with students. Parent also receive text messages throughout the year.

Also known as: First Years Away from Home
Handbook plus condition

Eligibility Criteria

Age17 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Students at least 17 and under 22 years of age who are attending college for first time

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Pullman, Washington, 99164, United States

Location

Related Publications (2)

  • Bruzios KE, Cooper BR, Duckworth J, Hill CM, Hill L. Classes of Caregiver-Student Responsiveness to a Self-Directed Handbook Preventive Intervention and Their Associated Impact on First-Year Student Substance Use. Prev Sci. 2025 Aug;26(6):956-967. doi: 10.1007/s11121-025-01832-9. Epub 2025 Jul 31.

  • Hill LG, Bumpus M, Haggerty KP, Catalano RF, Cooper BR, Skinner ML. "Letting Go and Staying Connected": Substance Use Outcomes from a Developmentally Targeted Intervention for Parents of College Students. Prev Sci. 2023 Aug;24(6):1174-1186. doi: 10.1007/s11121-023-01520-6. Epub 2023 Mar 18.

MeSH Terms

Conditions

Substance-Related DisordersRisk Reduction BehaviorMarijuana AbusePrescription Drug Misuse

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehaviorDrug Misuse

Study Officials

  • Laura G Hill, PhD

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two experimental groups (one group receives a handbook, one group receives a handbook plus text messages) and one control group (no intervention)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 24, 2017

Study Start

April 1, 2017

Primary Completion

May 11, 2020

Study Completion

September 14, 2021

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations