Clinical trial NCT05900115: Feasibility Study of a Web-based Program to Help Parents of Middle School Students Effectively Communicate With Their Children About Substance Use
Official title: The Middle Years Study: A Feasibility Study of a Self-paced Program Designed to Provide Parents of Middle School-aged Students With Knowledge About Teen Substance Use and Practice in High Quality Parent-adolescent Communication Methods Delivered Through a Highly Interactive Web-based Software Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Parenting
Communication
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-06-12
Enrollment: 576
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to test the feasibility of a web-based program for parents of middle school aged students. 286 parents and their child in 6th, 7th, or 8th grade will be asked to each complete two online questionnaires over the course of about a month, parents will also complete a web-based program between questionnaires. Researchers will compare the intervention and an active control to test the intervention program efficacy for improving outcomes related to parent-child communication, media message processing, and adolescent health.

Detailed description: The purpose of this study is to evaluate and assess a self-administered, web-based program designed to increase parent knowledge about adolescent substance use, active media mediation skills, and practice high-quality parent-adolescent communication methods. The program will help parents of middle-school aged students, 6th-8th graders, communicate effectively about substance use and enhance media literacy skills to counter unhealthy media messages. Prevention efforts are most impacting for adolescents in middle school years as this is the time frame for growing independence, desire to fit-in and an increase risk for their own experimentation with substances.

Eligibility criteria: Inclusion Criteria:

* The adult must be the legal guardian of a child in 6th, 7th or 8th grade (known hereafter as "parent").
* The parent must be able and willing to receive email and text communication as part of the study.
* The parent-child pair must have access to a smartphone with internet connection as the resource review will be completed online in a format that is best viewed on a smartphone.
* The parent-child pair must be fluent in English as the study materials are conducted in English.
* The parent must indicate that they will give the child participant privacy to complete the questionnaires
* Both the adult and child must agree to participate.

Exclusion Criteria:

* In an effort to ensure diversity in parent gender and race/ethnicity, not all eligible pairs who are interested in participating will be enrolled in the study.

Primary outcomes:
measure: Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Child Report of Parent-child Communication Quality at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Child Report of Parental Active Media Mediation at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Child Substance Use Intentions at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Child Willingness to Use Substances at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: innovation Research and Training
state: North Carolina
Study officials:
References: