<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227809</url>
  </required_header>
  <id_info>
    <org_study_id>123980-002</org_study_id>
    <nct_id>NCT03227809</nct_id>
  </id_info>
  <brief_title>First Years Away From Home: Letting Go and Staying Connected</brief_title>
  <acronym>FYAH:LGSC</acronym>
  <official_title>A Randomized Trial of Letting Go and Staying Connected, an Interactive Parenting Intervention to Reduce Risky Behaviors Among Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alcohol abuse is the leading cause of death and serious injury among college students, and&#xD;
      students also experience significant harms from other types of substance misuse and risk&#xD;
      behaviors. The proposed project is a randomized controlled trials that will test the&#xD;
      protective effects of Letting Go and Staying Connected, a handbook for parents of students&#xD;
      who are transitioning for the first time from home to college, the time when students are at&#xD;
      greatest risk. The handbook encourages parent skill development and good management of their&#xD;
      student's new independence, providing a clear framework to guide them in parenting at this&#xD;
      stage. Targeted outcomes include reduction of substance use and risk behaviors. The primary&#xD;
      hypothesis is that students who are in one of the two handbook conditions with their parents&#xD;
      will report lower substance use and risk behaviors in the two years after college entry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial (RCT) with two experimental conditions (Handbook and&#xD;
      Handbook+) and a control. Each condition will be composed of 450 student/parent dyads, about&#xD;
      half in Cohort 1 and half in Cohort 2. Participants will be recruited from the incoming&#xD;
      freshman classes at Washington State University in 2017 and 2018 by the Social Development&#xD;
      Research Group (SDRG) at University of Washington. Parents in both experimental conditions&#xD;
      will receive a handbook in the summer before school starts. The handbook contains suggested&#xD;
      conversation starters, checklists, and activities to be completed by the parent/student dyad.&#xD;
      Activities are based in theory of social and emotional development and designed to address&#xD;
      risk and protective factors for this age group as they transition to living independently&#xD;
      from parents. Handbook plus parents will additionally receive text messages periodically&#xD;
      throughout the fall and spring semesters, some of which are designed to let them know about&#xD;
      major university events (e.g. home football games) which are known to be high-risk periods.&#xD;
      Each cohort will be followed for two years. Parents complete surveys at baseline (spring&#xD;
      before students starts) and in fall semester. Students complete surveys at baseline and each&#xD;
      semester for their first two years at school.&#xD;
&#xD;
      Specific Aims of the project are as follows:&#xD;
&#xD;
      Aim 1: Test the efficacy of Letting Go and Staying Connected, a theoretically guided,&#xD;
      developmentally targeted, and empirically supported handbook intervention for parents of&#xD;
      students transitioning to college. The investigators hypothesize that students in the&#xD;
      Handbook conditions will engage in fewer risk behaviors, including initiation, use, and abuse&#xD;
      of substances (alcohol, marijuana, opiates, and prescription stimulants) and HIV/sex risk&#xD;
      behaviors. As a result, Handbook students will also report fewer physical, emotional, social,&#xD;
      and academic harms. The investigators will test a control condition vs. a &quot;Handbook Only&quot; and&#xD;
      a &quot;Handbook Plus&quot; condition (an enhanced version of the intervention that adds&#xD;
      strategically-timed Short Message Service and/or emails designed to increase utilization of&#xD;
      the intervention).&#xD;
&#xD;
      Aim 2: Test theoretically specified mediational pathways between Handbook utilization and the&#xD;
      expected intervention changes in risk behaviors/associated harms. The investigators expect&#xD;
      that the effect of the Handbook on student outcomes will be mediated by both parent and&#xD;
      student behaviors, as described in the following path: 1) Parent engagement in and use of the&#xD;
      intervention 2) Parent practices in family management, autonomy support, and emotional&#xD;
      support 3) Students' perceived rewards for healthy behaviors 4) Healthy connections with&#xD;
      parents and peers 5) Healthy beliefs and clear standards leading to 6) Reduced substance use&#xD;
      and sex risk behaviors; increased academic performance.&#xD;
&#xD;
      Aim 3: Identify specific attributes of parent-student communication that predict and covary&#xD;
      with student substance use and HIV/sex risk behaviors. Early in their first semester, the&#xD;
      investigators will survey students intensively over 2 periods of 7 days to learn about their&#xD;
      daily communication with parents and their daily risk behaviors. Because little is known&#xD;
      about parent-student communication at this developmental stage, the investigators will&#xD;
      conduct descriptive and exploratory analyses on the content, emotional tone, timing,&#xD;
      duration, mode, and frequency of parents' communication with their students and examine how&#xD;
      those aspects of communication relate to student risk behaviors and associated harms at both&#xD;
      a between-person and a within-person level.&#xD;
&#xD;
      The SDRG has extensive experience in recruitment, data collection, data management, and data&#xD;
      security. The investigators' detailed Data Safety Monitoring Plan contains information about&#xD;
      specific procedures used to safeguard participant information. The investigators will recruit&#xD;
      underrepresented students in proportion to Washington State University (WSU) student&#xD;
      percentages. SDRG also has extensive experience in retaining study participants, in some&#xD;
      studies for more than 20 years.&#xD;
&#xD;
      Data cleaning. The investigators will conduct tests for out-of-range values, consistency&#xD;
      across measurement points, normality, and influential outliers. The investigators will&#xD;
      address any issues of bias related to outliers using accepted techniques (e.g. analyses&#xD;
      robust to violation of assumptions). Counts of dichotomous substance use variables are&#xD;
      frequently skewed; the investigators will use log transformations of variables and&#xD;
      appropriate analyses (e.g. survival analysis or Poisson regressions) as needed.&#xD;
&#xD;
      Selection and Attrition. Randomized selection of students for invitation into the study&#xD;
      should ensure a representative sample of the student population, and numerous studies have&#xD;
      demonstrated the ability of the Survey Research Division at the SDRG to retain over 90% of&#xD;
      respondents over more than 10 years. However, the investigators will test for differential&#xD;
      participation and attrition and for the likelihood of biased outcome estimates; if necessary,&#xD;
      the investigators will model those effects and employ correction techniques.&#xD;
&#xD;
      Variability in Implementation and Dosage. Particularly in the case of a self-administered&#xD;
      intervention, implementation and dosage are not distributed randomly -- for example, parents&#xD;
      in the intervention condition who are particularly motivated or compliant may do all&#xD;
      activities, whereas others may pick and choose. The non-random distribution of intervention&#xD;
      components across intervention participants confounds the ability to draw causal inferences&#xD;
      about program effects and obscures the mechanisms of program effects by treating&#xD;
      implementation as a binary event. In addition to intent-to-treat analyses the investigators&#xD;
      will employ recent methodological advances that allow for estimation, modeling, and control&#xD;
      of selection effects in implementation through use of propensity scoring and inverse&#xD;
      probability weighting.&#xD;
&#xD;
      Missing Data. When respondents skip items or miss one or more data collection points, missing&#xD;
      data may introduce bias and increase the likelihood of Type I errors. The investigators'&#xD;
      primary analytic approaches use Full Information Maximum Likelihood (FIML)(38) to manage&#xD;
      missing data. In case of excessive missingness, the investigators will use multiple&#xD;
      imputation .&#xD;
&#xD;
      Family-wise Error. The investigators will use summary variables of risk behaviors/harms, but&#xD;
      the investigators will also conduct separate analyses for each risk outcome to provide a&#xD;
      finer-grained look at individual substances, increasing the likelihood of a Type 1 error.&#xD;
      Responses to substance use items are also likely to be highly correlated; in such cases&#xD;
      standard Bonferroni corrections tend to be overly conservative with a higher likelihood of&#xD;
      Type 2 error. Resampling procedures (e.g. Statistical Analysis Software (SAS) Procedure&#xD;
      MULTTEST) are more powerful than the Bonferroni test and can be applied to categorical,&#xD;
      continuous, and censored data tests, mixed method analyses of between-subjects effects and&#xD;
      longitudinal within-subject tests(15,148). A global test statistic will be used when&#xD;
      appropriate.&#xD;
&#xD;
      Analyses: Aim 1: To measure intervention impact on change across time the investigators will&#xD;
      model latent growth curves (LGC) for each of the hypothesized outcomes. First, unconditional&#xD;
      models will be estimated to confirm the expected escalation across 5 waves of data. The&#xD;
      investigators expect a two factor model: an intercept factor set to pre-test levels, and a&#xD;
      linear slope factor estimated with factor loadings set to indicate pre-test as intercept and&#xD;
      non-equal intervals between surveys. A non-linear slope will be estimated using quadratic&#xD;
      forms for loadings, however the investigators expect primarily linearly increases over all 5&#xD;
      time points. A covariance is typically estimated between the intercept and slope factors to&#xD;
      control for pre-test levels of the outcome. Control variables will be added in the next step.&#xD;
      Finally, intervention group assignment (in the form of 2 dummy variables) will be added as&#xD;
      predictors of the mean and variance of the slope factor (random assignment should preclude&#xD;
      group effects on the intercept set at pre-test). The investigators expect these parameters to&#xD;
      reflect significant positive slope means and variances in the unconditional model and the&#xD;
      minimally conditional model. In the final models, intervention dummy variables are&#xD;
      hypothesized to have significant negative effects on slope mean and variance compared to the&#xD;
      control condition indicating both intervention conditions reduced the rate of escalation in&#xD;
      risk behaviors and consequences and also reduced the variability in these outcomes. By&#xD;
      manipulating the coding of dummy variables the investigators can then test the comparison&#xD;
      between H and H+ with the expectation that H+ parameters will be significantly more strongly&#xD;
      negative than those for H.&#xD;
&#xD;
      Aim 2: Preliminary intent-to-treat analyses (ANCOVA) will be conducted on mediators at each&#xD;
      follow up as described for outcomes above. Then LGC analyses described above will be extended&#xD;
      to include mediating variables. However, prior to estimating mediation, each mediator will be&#xD;
      modeled over time in a LGC model to determine its shape (intercept, linear slope, and&#xD;
      quadratic slope) conditioned on control variables as described for outcomes in Aim 1. In the&#xD;
      case of mediators the slope factors are less predictable, although in general these positive&#xD;
      parenting and parent-student relationship factors are expected to decline over time. Once&#xD;
      appropriate models of change have been determined, concurrent/parallel growth processes in&#xD;
      mediators and outcomes will be estimated. Parallel process Longitudinal Growth Modeling (LGM)&#xD;
      is a technique that has been used to examine interrelationships among various developmental&#xD;
      outcomes, including co-occurring drug use and delinquency, in adolescents and young adults&#xD;
      and for testing the mechanisms of preventive intervention effects. In the final step the&#xD;
      intervention group status dummy variables will be added to the parallel process models.&#xD;
&#xD;
      Aim 3: Given the exploratory nature of this aim, there are no hypotheses. Note that changes&#xD;
      in communication are not posited to mediate intervention effects. However, if significant&#xD;
      relationships are found between intervention status and communication measures, exploratory&#xD;
      analyses may be conducted on the control group only to better reflect etiological&#xD;
      relationships un-confounded by possible intervention influences. Preliminary analyses will&#xD;
      focus on describing levels and variability in content, emotional tone, timing, duration,&#xD;
      mode, and frequency and developing appropriate summary scores to best reflect these factors&#xD;
      based on reports from the Time Line Follow Back surveys. Latent class analyses (LCA) with&#xD;
      maximum likelihood estimation and robust standard errors will be used to explore&#xD;
      parent-student communication patterns using those summary scores. The investigators will&#xD;
      derive empirically based classes of participants based on content, emotional tone, timing,&#xD;
      duration, mode, and frequency. This will involve estimating a series of models to determine&#xD;
      the number of unique classes that best fit the data by comparing the Bayesian Information&#xD;
      Criterion, the Lo-Mendell-Rubin adjusted Likelihood Ratio test and the Parametric&#xD;
      Bootstrapped Likelihood Ratio test across models and selecting the most parsimonious model&#xD;
      with the best fit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">September 14, 2021</completion_date>
  <primary_completion_date type="Actual">May 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change over time in 30-day alcohol use</measure>
    <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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative grade point average</measure>
    <time_frame>End of each semester during first two years of school, at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline</time_frame>
    <description>University administrative data will be examined to examine students' cumulative Grade Point Average</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous matriculation at university during first two years</measure>
    <time_frame>End of each semester during first two years of school, at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline</time_frame>
    <description>University administrative data will be examined to determine whether students have withdrawn from university at any time during the first two academic years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Past 30-day frequency of risky sexual behavior</measure>
    <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.</time_frame>
    <description>Changes from baseline in frequency of risky sexual behavior</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifetime alcohol use (Cohort 2 only)</measure>
    <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.</time_frame>
    <description>Changes from baseline in lifetime alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Past 30-day frequency of marijuana use</measure>
    <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.</time_frame>
    <description>Number of occasions marijuana used in past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Past 30-day frequency of prescription drug misuse</measure>
    <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.</time_frame>
    <description>Number of occasions prescription drugs misused in past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Past 30-day frequency of illicit drug use</measure>
    <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.</time_frame>
    <description>Number of occasions illicit drugs used in past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifetime marijuana use</measure>
    <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.</time_frame>
    <description>Changes from baseline in lifetime marijuana use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifetime prescription drug misuse</measure>
    <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.</time_frame>
    <description>Changes from baseline in prescription drug misuse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifetime illicit drug use</measure>
    <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.</time_frame>
    <description>Changes from baseline in lifetime illicit drug use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifetime risky sexual behaviors</measure>
    <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.</time_frame>
    <description>Changes from baseline in lifetime risky sexual behaviors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Past two-week heavy episodic drinking episodes</measure>
    <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.</time_frame>
    <description>How frequently in the past two weeks student has had more than 4 (female) or 5 (male) drinks in one setting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutgers Alcohol Problem Index (White &amp; LaBouvie, 1989)</measure>
    <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.</time_frame>
    <description>How frequently students have experienced any of a list of specific consequences related to alcohol use over past month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Marijuana Consequences Index (Lee, 2016)</measure>
    <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.</time_frame>
    <description>How frequently students have experienced any of a list of specific consequences related to marijuana use over past month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Consequences Index (National College Health Assessment, 2016)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>How frequently students have experienced any of a list of specific consequences related to sexual activities over past month</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reinforcement of positive behaviors by parents (Aldeis &amp; Afifi, 2013)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>The degree to which parents recognize and reward students' positive behaviors</description>
  </other_outcome>
  <other_outcome>
    <measure>Peer rewards for antisocial behaviors (Arthur, Hawkins et al., 2002)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>The degree to which peers approve of students' risk behaviors</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental attitudes favorable to drug use (Arthur, Hawkins et al., 2002)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>The degree to which parents approve of students' drug use</description>
  </other_outcome>
  <other_outcome>
    <measure>Student attitudes favorable to drug use (Arthur, Hawkins et al., 2002)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>The degree to which students approve of drug use</description>
  </other_outcome>
  <other_outcome>
    <measure>Sense of belonging (Paunesku et al., 2015)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>The degree to which students feel they belong at college</description>
  </other_outcome>
  <other_outcome>
    <measure>Parent-Student Communication about Alcohol Scale (Abar, Fernandez &amp; Wood, 2011)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>Measure of the degree to which parents communicate expectations about alcohol use to their young adult children</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental Monitoring and Consequences (Arria et al., 2008)</measure>
    <time_frame>Baseline only</time_frame>
    <description>Measure of the degree to which parents monitor and supervise young adult childrens' social activities</description>
  </other_outcome>
  <other_outcome>
    <measure>Perception of Parents Scale (Johnson, 2004)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>Measure of the degree to which parents support development of young adult children's autonomy</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional closeness between parent and student (Aldeis &amp; Afifi, 2013)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>Measure of the degree to which students feel close to parents</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of parent-student communication (Developed for study)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>How often students and parents have communicated in past two weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Modality of parent-student communication (Developed for study)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>How students and parents have communicated in past two weeks (e.g. phone, text, email)</description>
  </other_outcome>
  <other_outcome>
    <measure>Content of parent-student communication (Developed for study)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>Main topics students and parents have communicated about in past two weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional tone of parent-student communication (Developed for study)</measure>
    <time_frame>Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.</time_frame>
    <description>How students perceive emotional tone of communication with parents in past two weeks</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">910</enrollment>
  <condition>Substance Abuse</condition>
  <condition>Risk Reduction</condition>
  <condition>RIsky Sexual Behavior</condition>
  <arm_group>
    <arm_group_label>Handbook condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents in this condition receive a handbook designed for parents of first-year college-going students the summer before school starts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Handbook plus condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Parents receive treatment as usual of incoming university student parents</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Handbook condition</intervention_name>
    <description>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.</description>
    <arm_group_label>Handbook condition</arm_group_label>
    <other_name>First Years Away from Home</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Handbook plus condition</intervention_name>
    <description>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.</description>
    <arm_group_label>Handbook plus condition</arm_group_label>
    <other_name>First Years Away from Home</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students at least 17 and under 22 years of age who are attending college for first&#xD;
             time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking students/parents&#xD;
&#xD;
          -  Students whose primary residence is outside the U.S.&#xD;
&#xD;
          -  Students who will be living at home rather than at school&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura G Hill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington State University</name>
      <address>
        <city>Pullman</city>
        <state>Washington</state>
        <zip>99164</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 3, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington State University</investigator_affiliation>
    <investigator_full_name>Laura Griner Hill</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>College student risk behavior prevention</keyword>
  <keyword>Substance use</keyword>
  <keyword>Alcohol</keyword>
  <keyword>Marijuana</keyword>
  <keyword>Illicit drugs</keyword>
  <keyword>Prescription drug misuse</keyword>
  <keyword>Risky sexual behaviors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We are willing to share de-identified data upon request three years after study completion</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03227809/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>July 18, 2022</submitted>
    <returned>June 6, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227809
org study id: 123980-002
nct id: NCT03227809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.

      The SDRG has extensive experience in recruitment, data collection, data management, and data
      security. The investigators' detailed Data Safety Monitoring Plan contains information about
      specific procedures used to safeguard participant information. The investigators will recruit
      underrepresented students in proportion to Washington State University (WSU) student
      percentages. SDRG also has extensive experience in retaining study participants, in some
      studies for more than 20 years.

      Data cleaning. The investigators will conduct tests for out-of-range values, consistency
      across measurement points, normality, and influential outliers. The investigators will
      address any issues of bias related to outliers using accepted techniques (e.g. analyses
      robust to violation of assumptions). Counts of dichotomous substance use variables are
      frequently skewed; the investigators will use log transformations of variables and
      appropriate analyses (e.g. survival analysis or Poisson regressions) as needed.

      Selection and Attrition. Randomized selection of students for invitation into the study
      should ensure a representative sample of the student population, and numerous studies have
      demonstrated the ability of the Survey Research Division at the SDRG to retain over 90% of
      respondents over more than 10 years. However, the investigators will test for differential
      participation and attrition and for the likelihood of biased outcome estimates; if necessary,
      the investigators will model those effects and employ correction techniques.

      Variability in Implementation and Dosage. Particularly in the case of a self-administered
      intervention, implementation and dosage are not distributed randomly -- for example, parents
      in the intervention condition who are particularly motivated or compliant may do all
      activities, whereas others may pick and choose. The non-random distribution of intervention
      components across intervention participants confounds the ability to draw causal inferences
      about program effects and obscures the mechanisms of program effects by treating
      implementation as a binary event. In addition to intent-to-treat analyses the investigators
      will employ recent methodological advances that allow for estimation, modeling, and control
      of selection effects in implementation through use of propensity scoring and inverse
      probability weighting.

      Missing Data. When respondents skip items or miss one or more data collection points, missing
      data may introduce bias and increase the likelihood of Type I errors. The investigators'
      primary analytic approaches use Full Information Maximum Likelihood (FIML)(38) to manage
      missing data. In case of excessive missingness, the investigators will use multiple
      imputation .

      Family-wise Error. The investigators will use summary variables of risk behaviors/harms, but
      the investigators will also conduct separate analyses for each risk outcome to provide a
      finer-grained look at individual substances, increasing the likelihood of a Type 1 error.
      Responses to substance use items are also likely to be highly correlated; in such cases
      standard Bonferroni corrections tend to be overly conservative with a higher likelihood of
      Type 2 error. Resampling procedures (e.g. Statistical Analysis Software (SAS) Procedure
      MULTTEST) are more powerful than the Bonferroni test and can be applied to categorical,
      continuous, and censored data tests, mixed method analyses of between-subjects effects and
      longitudinal within-subject tests(15,148). A global test statistic will be used when
      appropriate.

      Analyses: Aim 1: To measure intervention impact on change across time the investigators will
      model latent growth curves (LGC) for each of the hypothesized outcomes. First, unconditional
      models will be estimated to confirm the expected escalation across 5 waves of data. The
      investigators expect a two factor model: an intercept factor set to pre-test levels, and a
      linear slope factor estimated with factor loadings set to indicate pre-test as intercept and
      non-equal intervals between surveys. A non-linear slope will be estimated using quadratic
      forms for loadings, however the investigators expect primarily linearly increases over all 5
      time points. A covariance is typically estimated between the intercept and slope factors to
      control for pre-test levels of the outcome. Control variables will be added in the next step.
      Finally, intervention group assignment (in the form of 2 dummy variables) will be added as
      predictors of the mean and variance of the slope factor (random assignment should preclude
      group effects on the intercept set at pre-test). The investigators expect these parameters to
      reflect significant positive slope means and variances in the unconditional model and the
      minimally conditional model. In the final models, intervention dummy variables are
      hypothesized to have significant negative effects on slope mean and variance compared to the
      control condition indicating both intervention conditions reduced the rate of escalation in
      risk behaviors and consequences and also reduced the variability in these outcomes. By
      manipulating the coding of dummy variables the investigators can then test the comparison
      between H and H+ with the expectation that H+ parameters will be significantly more strongly
      negative than those for H.

      Aim 2: Preliminary intent-to-treat analyses (ANCOVA) will be conducted on mediators at each
      follow up as described for outcomes above. Then LGC analyses described above will be extended
      to include mediating variables. However, prior to estimating mediation, each mediator will be
      modeled over time in a LGC model to determine its shape (intercept, linear slope, and
      quadratic slope) conditioned on control variables as described for outcomes in Aim 1. In the
      case of mediators the slope factors are less predictable, although in general these positive
      parenting and parent-student relationship factors are expected to decline over time. Once
      appropriate models of change have been determined, concurrent/parallel growth processes in
      mediators and outcomes will be estimated. Parallel process Longitudinal Growth Modeling (LGM)
      is a technique that has been used to examine interrelationships among various developmental
      outcomes, including co-occurring drug use and delinquency, in adolescents and young adults
      and for testing the mechanisms of preventive intervention effects. In the final step the
      intervention group status dummy variables will be added to the parallel process models.

      Aim 3: Given the exploratory nature of this aim, there are no hypotheses. Note that changes
      in communication are not posited to mediate intervention effects. However, if significant
      relationships are found between intervention status and communication measures, exploratory
      analyses may be conducted on the control group only to better reflect etiological
      relationships un-confounded by possible intervention influences. Preliminary analyses will
      focus on describing levels and variability in content, emotional tone, timing, duration,
      mode, and frequency and developing appropriate summary scores to best reflect these factors
      based on reports from the Time Line Follow Back surveys. Latent class analyses (LCA) with
      maximum likelihood estimation and robust standard errors will be used to explore
      parent-student communication patterns using those summary scores. The investigators will
      derive empirically based classes of participants based on content, emotional tone, timing,
      duration, mode, and frequency. This will involve estimating a series of models to determine
      the number of unique classes that best fit the data by comparing the Bayesian Information
      Criterion, the Lo-Mendell-Rubin adjusted Likelihood Ratio test and the Parametric
      Bootstrapped Likelihood Ratio test across models and selecting the most parsimonious model
      with the best fit.
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)
primary purpose: Prevention
masking: None (Open Label)
measure: 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.
description: 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.
measure: 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
description: University administrative data will be examined to examine students' cumulative Grade Point Average
measure: 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
description: University administrative data will be examined to determine whether students have withdrawn from university at any time during the first two academic years
measure: 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.
description: Changes from baseline in frequency of risky sexual behavior
measure: 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.
description: Changes from baseline in lifetime alcohol use
measure: 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.
description: Number of occasions marijuana used in past 30 days
measure: 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.
description: Number of occasions prescription drugs misused in past 30 days
measure: 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.
description: Number of occasions illicit drugs used in past 30 days
measure: 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.
description: Changes from baseline in lifetime marijuana use
measure: 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.
description: Changes from baseline in prescription drug misuse
measure: 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.
description: Changes from baseline in lifetime illicit drug use
measure: 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.
description: Changes from baseline in lifetime risky sexual behaviors
measure: 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.
description: How frequently in the past two weeks student has had more than 4 (female) or 5 (male) drinks in one setting
measure: 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.
description: How frequently students have experienced any of a list of specific consequences related to alcohol use over past month
measure: 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.
description: How frequently students have experienced any of a list of specific consequences related to marijuana use over past month
measure: 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.
description: How frequently students have experienced any of a list of specific consequences related to sexual activities over past month
measure: 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.
description: The degree to which parents recognize and reward students' positive behaviors
measure: 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.
description: The degree to which peers approve of students' risk behaviors
measure: 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.
description: The degree to which parents approve of students' drug use
measure: 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.
description: The degree to which students approve of drug use
measure: Sense of belonging (Paunesku et al., 2015)
time frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.
description: The degree to which students feel they belong at college
measure: 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.
description: Measure of the degree to which parents communicate expectations about alcohol use to their young adult children
measure: Parental Monitoring and Consequences (Arria et al., 2008)
time frame: Baseline only
description: Measure of the degree to which parents monitor and supervise young adult childrens' social activities
measure: Perception of Parents Scale (Johnson, 2004)
time frame: Baseline and again at 26 weeks, 52 weeks, 77 weeks, and 104 weeks after baseline.
description: Measure of the degree to which parents support development of young adult children's autonomy
measure: 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.
description: Measure of the degree to which students feel close to parents
measure: 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.
description: How often students and parents have communicated in past two weeks
measure: 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.
description: How students and parents have communicated in past two weeks (e.g. phone, text, email)
measure: 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.
description: Main topics students and parents have communicated about in past two weeks
measure: 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.
description: How students perceive emotional tone of communication with parents in past two weeks
arm group label: Handbook condition
arm group type: Experimental
description: Parents in this condition receive a handbook designed for parents of first-year college-going students the summer before school starts
arm group label: Handbook plus condition
arm group type: Experimental
description: 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
arm group label: Control
arm group type: No Intervention
description: Parents receive treatment as usual of incoming university student parents
intervention type: Behavioral
intervention name: Handbook condition
description: 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.
arm group label: Handbook condition
other name: First Years Away from Home
intervention type: Behavioral
intervention name: Handbook plus condition
description: 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.
arm group label: Handbook plus condition
other name: First Years Away from Home
criteria: 
gender: All
minimum age: 17 Years
maximum age: 22 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laura G Hill, PhD
role: Principal Investigator
affiliation: Washington State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington State University
investigator full name: Laura Griner Hill
investigator title: Professor
mesh term: Substance-Related Disorders
sharing ipd: Undecided
ipd description: We are willing to share de-identified data upon request three years after study completion
provided document: 
submitted: July 18, 2022
returned: June 6, 2023