Clinical trial NCT03932097: REAL Parenting Alcohol and Substance Use App
Official title: Feasibility of a Mobile Parent-based Intervention to Reduce Alcohol Use by High School Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Underage Drinking
Alcohol Use, Underage
Lead sponsor: Real Prevention, LLC
Sponsor class: INDUSTRY
First posted: 2019-04-30
Enrollment: 306
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 REAL Parenting (RP). RP 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, RP 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Alcohol Use
timeFrame: Project years 1-2
Secondary outcomes:
measure: Marijuana Use
timeFrame: Project years 1-2
measure: Combined Use
timeFrame: Project years 1-2
measure: Consequences of Alcohol Use
timeFrame: Project years 1-2
measure: Nicotine Use
timeFrame: Project years 1-2
Other outcomes:
measure: Alcohol Motives
timeFrame: Project years 1-2
measure: Alcohol Expectancies
timeFrame: Project years 1-2
measure: Alcohol Willingness
timeFrame: Project years 1-2
measure: Alcohol Norms
timeFrame: Project years 1-2
measure: Parental Communication
timeFrame: Project years 1-2
Locations:
city: Clifton
country: United States
facility: REAL Prevention, LLC
state: New Jersey
Study officials:
affiliation: REAL Prevention
name: Michael Hecht
role: PRINCIPAL_INVESTIGATOR
References: