Parenting Now Alcohol and Substance Use App (ParentingNow)

• ClinicalTrials.gov Identifier: NCT03932097
• Recruitment Status: Recruiting
• First Posted: April 30, 2019
• Last Update Posted: September 11, 2019
• Sponsor: Real Prevention, LLC
• Information provided by (Responsible Party): Michael Hecht, Real Prevention, LLC

Study Description

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 Parenting Now). Parent-teen dyads will be invited to participate and complete baseline assessment and parents will receive the Parenting Now or active control materials shortly afterwards. This will allow an examination of the impact of the PN on alcohol use, and associated consequences and sustained effects across the follow-up period.

Condition or disease	Intervention/treatment	Phase
Underage Drinking; Alcohol Use, Underage	Behavioral: Parenting Now; Other: Active Control Materials	Not Applicable

Detailed Description:

The goal of this Phase II SBIR is to provide an efficient, engaging, and effective means to enhance parents' ability to reduce prevalence of alcohol use and consequences, and other substance use through the development and evaluation of Parenting Now (PN). PN is a brief, interactive, self-paced, and digital curriculum for parents of high-school-aged adolescents, a frequently neglected population created from the evidence-based Parent Handbook,available in hard copy and DVD for college-bound youth only. The curriculum is needed because most parent-based prevention interventions target children or young adolescents, neglecting older adolescents, despite that fact that alcohol use increases in frequency and risk through midadolescence. Also, unlike other evidence-based parenting curricula, PN is brief, requires only the parents, does not require training, and can be used "on the go" through any digital device. This provides a market niche for the proposed project that addresses this curriculum gap through the innovative use of both technology and prevention science. This format will allow us to personalize or target parents based on their communication style and allows parents to customize their experience by choosing or clicking through the optional content. Personalization and customization are two essential engagement strategies for digital prevention interventions.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Feasibility of a Mobile Parent-based Intervention to Reduce Alcohol Use by High School Seniors
• Actual Study Start Date: June 1, 2019
• Estimated Primary Completion Date: May 1, 2021
• Estimated Study Completion Date: May 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Parenting Now; Preventive Parenting Now 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: Parenting Now; Preventive Parenting Now 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.
Active Comparator: Active Control Materials; SAMHSA alcohol prevention materials for parents	Other: Active Control Materials; SAMHSA alcohol prevention materials for parents

Outcome Measures

Primary Outcome Measures :

1. Alcohol Use [ Time Frame: Project years 1-2 ]
   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.

Secondary Outcome Measures :

1. Marijuana Use [ Time Frame: Project years 1-2 ]
   Frequency of use will be assessed by asking how often participants used marijuana during the past six months using a 7-point scale ranging from (0) never to (6) 40 or more times.
2. Combined Use [ Time Frame: Project years 1-2 ]
   Frequency of combined use will be assessed for participants indicating marijuana and nicotine use with a single item: During times you used marijuana, how often did you also drink alcohol? using a 6-point scale ranging from (0) never to (5) 40 or more times. For participants that indicate their peak drinking occasion a follow up question will assess whether marijuana or nicotine was also used(yes or no).
3. Consequences of Alcohol Use [ Time Frame: Project years 1-2 ]
   Alcohol-related consequences (e.g., said or done embarrassing things, blackout) from the past six months will be measured using the established Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Read, Kahler, Strong, & Colder, 2006). Response options will again be measured on the same a 7-point scale as Combined Use.
4. Nicotine Use [ Time Frame: Project years 1-2 ]
   Frequency of use will be assessed by asking how often participants used nicotine products (tobacco, vaping, snuff) during the past six months using a 7-point scale ranging from (0) never to (6) 40 or more times.

Other Outcome Measures:

1. Alcohol Motives [ Time Frame: Project years 1-2 ]
   Using the past six months as a time reference, participants will be asked about their motivations to use alcohol. Twenty items for each substance will assess motives for using alcohol, such as "to be sociable" and "to forget about your problems" on a 5-point scale ranging from (1) almost never/never to (5) almost always/always.
2. Alcohol Expectancies [ Time Frame: Project years 1-2 ]
   Alcohol expectancies will be measured using a 7-point scale ranging from (-3) strongly disagree to (3) strongly agree. Items will assess how likely a variety of alcohol-related consequences will be experienced in the next few months. For example, items, be worded specifically for alcohol use, such as "I will feel badly about myself because of my drinking."
3. Alcohol Willingness [ Time Frame: Project years 1-2 ]
   Response options for willingness items will be on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree. Willingness to use alcohol will be measured to assess participants? willingness to 1) drink once or twice in two hours; 2) drink 3-4 times in two hours; and 3) drink 5+ times in two hours. Willingness to use marijuana and COMBINE will be assessed individually with four items asking their willingness to use marijuana/COMBINE occasionally, regularly, weekly, and daily.
4. Alcohol Norms [ Time Frame: Project years 1-2 ]
   Perceived norms of drinking for the past six months will be measured using the DDQ using closest friend as a referent. To assess peer injunctive norms of alcohol use participants will be asked to indicate how acceptable their closest friends would find of a list of situations (e.g., drinking enough alcohol to pass out) using a (1) strongly disapprove to (7) strongly approve scale.
5. Parental Communication [ Time Frame: Project years 1-2 ]
   Parental communication about alcohol, nicotine, and marijuana use, COMBINE, and alcohol consequences will be assessed separately for parent and teen. Participants will be asked whether their parent discussed these topics (yes/no) with them within the past six months. Items include topics such as "the importance of not being pressured to drink to fit in" and "how marijuana works in the body."

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• High school students (ages 16-17)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 16-17 with their parents/guardians; English fluency; Internet access; at least one parent/guardian fluent in English and with Internet access

Exclusion Criteria:

-

Contacts and Locations

Contacts

Contact: Ann Bolser; 814-360-0203; ann@real-prevention.com

Locations

United States, New Jersey

REAL Prevention, LLC; Recruiting

Clifton, New Jersey, United States, 07013

Contact: Ann Bolser 814-360-0203 ann@real-prevention.com

Sponsors and Collaborators

Real Prevention, LLC

Investigators

• Principal Investigator: Michael Hecht; REAL Prevention

  Study Documents (Full-Text)

Documents provided by Michael Hecht, Real Prevention, LLC:

Study Protocol and Statistical Analysis Plan  [PDF] August 31, 2018

More Information

• Responsible Party: Michael Hecht, President, Real Prevention, LLC
• ClinicalTrials.gov Identifier: NCT03932097
• Other Study ID Numbers: 11690
• First Posted: April 30, 2019
• Last Update Posted: September 11, 2019
• Last Verified: September 2019

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

Additional relevant MeSH terms:

Alcohol Drinking; Underage Drinking; Drinking Behavior; Ethanol; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs