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First Years Away From Home: Letting Go and Staying Connected (FYAH:LGSC)

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ClinicalTrials.gov Identifier: NCT03227809
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Griner Hill, Washington State University

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Risk Reduction RIsky Sexual Behavior Behavioral: Handbook condition Behavioral: Handbook plus condition Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two experimental groups (one group receives a handbook, one group receives a handbook plus text messages) and one control group (no intervention)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Letting Go and Staying Connected, an Interactive Parenting Intervention to Reduce Risky Behaviors Among Students
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : September 14, 2021

Arm Intervention/treatment
Experimental: Handbook condition
Parents in this condition receive a handbook designed for parents of first-year college-going students the summer before school starts
Behavioral: 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.
Other Name: First Years Away from Home

Experimental: 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
Behavioral: Handbook plus 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.
Other Name: First Years Away from Home

No Intervention: Control
Parents receive treatment as usual of incoming university student parents



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cumulative grade point average [ Time Frame: End of each semester during first two years of school, at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline ]
    University administrative data will be examined to examine students' cumulative Grade Point Average

  2. Continuous matriculation at university during first two years [ Time Frame: End of each semester during first two years of school, at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline ]
    University administrative data will be examined to determine whether students have withdrawn from university at any time during the first two academic years

  3. Past 30-day frequency of risky sexual behavior [ Time Frame: 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. ]
    Changes from baseline in frequency of risky sexual behavior

  4. Lifetime alcohol use (Cohort 2 only) [ Time Frame: 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. ]
    Changes from baseline in lifetime alcohol use

  5. Past 30-day frequency of marijuana use [ Time Frame: 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. ]
    Number of occasions marijuana used in past 30 days

  6. Past 30-day frequency of prescription drug misuse [ Time Frame: 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. ]
    Number of occasions prescription drugs misused in past 30 days

  7. Past 30-day frequency of illicit drug use [ Time Frame: 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. ]
    Number of occasions illicit drugs used in past 30 days

  8. Lifetime marijuana use [ Time Frame: 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. ]
    Changes from baseline in lifetime marijuana use

  9. Lifetime prescription drug misuse [ Time Frame: 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. ]
    Changes from baseline in prescription drug misuse

  10. Lifetime illicit drug use [ Time Frame: 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. ]
    Changes from baseline in lifetime illicit drug use

  11. Lifetime risky sexual behaviors [ Time Frame: 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. ]
    Changes from baseline in lifetime risky sexual behaviors

  12. Past two-week heavy episodic drinking episodes [ Time Frame: 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. ]
    How frequently in the past two weeks student has had more than 4 (female) or 5 (male) drinks in one setting

  13. Rutgers Alcohol Problem Index (White & LaBouvie, 1989) [ Time Frame: 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. ]
    How frequently students have experienced any of a list of specific consequences related to alcohol use over past month

  14. Marijuana Consequences Index (Lee, 2016) [ Time Frame: 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. ]
    How frequently students have experienced any of a list of specific consequences related to marijuana use over past month

  15. Sexual Consequences Index (National College Health Assessment, 2016) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    How frequently students have experienced any of a list of specific consequences related to sexual activities over past month


Other Outcome Measures:
  1. Reinforcement of positive behaviors by parents (Aldeis & Afifi, 2013) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    The degree to which parents recognize and reward students' positive behaviors

  2. Peer rewards for antisocial behaviors (Arthur, Hawkins et al., 2002) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    The degree to which peers approve of students' risk behaviors

  3. Parental attitudes favorable to drug use (Arthur, Hawkins et al., 2002) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    The degree to which parents approve of students' drug use

  4. Student attitudes favorable to drug use (Arthur, Hawkins et al., 2002) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    The degree to which students approve of drug use

  5. Sense of belonging (Paunesku et al., 2015) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    The degree to which students feel they belong at college

  6. Parent-Student Communication about Alcohol Scale (Abar, Fernandez & Wood, 2011) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    Measure of the degree to which parents communicate expectations about alcohol use to their young adult children

  7. Parental Monitoring and Consequences (Arria et al., 2008) [ Time Frame: Baseline only ]
    Measure of the degree to which parents monitor and supervise young adult childrens' social activities

  8. Perception of Parents Scale (Johnson, 2004) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    Measure of the degree to which parents support development of young adult children's autonomy

  9. Emotional closeness between parent and student (Aldeis & Afifi, 2013) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    Measure of the degree to which students feel close to parents

  10. Frequency of parent-student communication (Developed for study) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    How often students and parents have communicated in past two weeks

  11. Modality of parent-student communication (Developed for study) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    How students and parents have communicated in past two weeks (e.g. phone, text, email)

  12. Content of parent-student communication (Developed for study) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    Main topics students and parents have communicated about in past two weeks

  13. Emotional tone of parent-student communication (Developed for study) [ Time Frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline. ]
    How students perceive emotional tone of communication with parents in past two weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227809


Contacts
Contact: Laura G Hill, PhD 509-335-8478 laurahill@wsu.edu
Contact: Danielle Woodward, PhD 206-685-1632 dgangnes@uw.edu

Locations
United States, Washington
Washington State University Recruiting
Pullman, Washington, United States, 99164
Contact: Laura G Hill, PhD    509-335-8478    laurahill@wsu.edu   
Contact: Matthew Bumpus, PhD    509-335-3816    mbumpus@wsu.edu   
Principal Investigator: Laura G Hill, PhD         
Sub-Investigator: Matthew Bumpus, PhD         
Sub-Investigator: Brittany R Cooper, PhD         
Sponsors and Collaborators
Washington State University
Investigators
Principal Investigator: Laura G Hill, PhD Washington State University
  Study Documents (Full-Text)

Documents provided by Laura Griner Hill, Washington State University:

Responsible Party: Laura Griner Hill, Professor, Washington State University
ClinicalTrials.gov Identifier: NCT03227809     History of Changes
Other Study ID Numbers: 123980-002
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are willing to share de-identified data upon request three years after study completion

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laura Griner Hill, Washington State University:
College student risk behavior prevention
Substance use
Alcohol
Marijuana
Illicit drugs
Prescription drug misuse
Risky sexual behaviors

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders