NCT03932097

Brief Summary

High school students' alcohol, nicotine, and marijuana use are major public health problems. Among the many consequences of these risky behaviors are impaired driving and impaired passenger fatalities as well as increased health risks. Both school administrators and parents have requested parent-based interventions (PBIs)for the general high school population that include content on alcohol, nicotine and marijuana use. In addition, digital materials are needed for the "on-the-go" parent. The proposed research will address this omission, curb the alarming trends noted above, and move the field forward by conducting a randomized controlled trial testing a modified, digital version of the Parent Handbook for the all high school students that includes additional content for parents to have broader discussions about combined alcohol nicotine and marijuana use alone (referred to as REAL Parenting). Parent-teen dyads will be invited to participate and complete baseline assessment and parents will receive the REAL Parenting or active control materials shortly afterwards. This will allow an examination of the impact of the RP on alcohol use, and associated consequences and sustained effects across the follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

April 25, 2019

Last Update Submit

May 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alcohol Use

    A standard drink definition will be provided: a standard drink consists of 12 oz. beer or wine cooler, 8.5 oz. of malt liquor, 4 oz. of wine, 3.5 oz. fortified wine, or 1.5 oz. of hard liquor. Typical weekly drinking: participants will respond to the Daily Drinking Questionnaire(DDQ; Collins et al., 1985) to indicate number of drinks consumed on each day of a typical week within the past six months. Participants will report maximum number of drinks consumed on an occasion within the past month and number of hours spent drinking on that occasion using the Quantity/Frequency/Peak questionnaire (QFP; Dimeff et al., 1999; Marlatt et al., 1998). Drunkenness will be assessed by asking how many times in the past month participants have gotten drunk, or very high from alcohol using a 6-point scale: (0) never to (5) 9 or more. Heavy episodic drinking will be measured for females and males separately, asking for number of times they?ve had 4/5, respectively, drinks in a row within two hours.

    Project years 1-2

Secondary Outcomes (4)

  • Marijuana Use

    Project years 1-2

  • Combined Use

    Project years 1-2

  • Consequences of Alcohol Use

    Project years 1-2

  • Nicotine Use

    Project years 1-2

Other Outcomes (5)

  • Alcohol Motives

    Project years 1-2

  • Alcohol Expectancies

    Project years 1-2

  • Alcohol Willingness

    Project years 1-2

  • +2 more other outcomes

Study Arms (2)

REAL Parenting

EXPERIMENTAL

REAL Parenting digital intervention emphasizing parent-teen/young adult communication on drinking/risks of drinking/risks of alcohol abuse, with the addition of a communication component on the risks of nicotine and marijuana use, with the goal of reducing alcohol, nicotine and marijuana use in college students.

Behavioral: REAL Parenting

Active Control Materials

ACTIVE COMPARATOR

NIAAA materials on underage drinking for parents

Other: Active Control Materials

Interventions

REAL ParentingBEHAVIORAL

REAL Parenting digital intervention emphasizing parent-teen/young adult communication on drinking/risks of drinking/risks of alcohol abuse, with the addition of a communication component on the risks of nicotine and marijuana use, with the goal of reducing alcohol, nicotine and marijuana use in college students.

REAL Parenting

NIAAA materials on underage drinking for parents

Active Control Materials

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school students (ages 15-18) who may be at risk for alcohol, marijuana and nicotine use and abuse, and whose parent/guardian is willing to participate in the proposed study as part of a parent/student dyad.
  • High school students ages 15-18 with their parents/guardians; English fluency; Internet access; at least one parent/guardian fluent in English and with Internet access

You may not qualify if:

  • Not high school aged (not ages 15-18)
  • Parent/guardian was not willing to participate
  • Does not have English fluency;
  • Does not have access to Internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REAL Prevention, LLC

Clifton, New Jersey, 07013, United States

Location

MeSH Terms

Conditions

Underage Drinking

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking Behavior

Study Officials

  • Michael Hecht

    REAL Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 30, 2019

Study Start

January 15, 2021

Primary Completion

January 15, 2022

Study Completion

May 31, 2022

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations