Feasibility Study of a Web-based Program to Help Parents of Middle School Students Effectively Communicate With Their Children About Substance Use

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

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.

Study Overview

• Status: Completed
• Conditions: Communication; Parenting; Substance Use
• Intervention / Treatment: Behavioral: Media Ready Parent; Behavioral: Active Control Program

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.

• Study Type: Interventional
• Enrollment (Actual): 576
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • innovation Research and Training

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web-based intervention; The intervention is a web-based resource that provides parents with media literacy and media mediation skills, knowledge about adolescent development and substance use, and practice in high quality parent-child communication.	Behavioral: Media Ready Parent; The intervention is a web-based resource that provides parents with media literacy and media mediation skills, knowledge about adolescent development and substance use, and practice in high quality parent-child communication.
Active Comparator: Active Control Program; The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.	Behavioral: Active Control Program; The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4	Parent-child communication quality will be adapted from the 16-item Parent-Adolescent Communication Scale (PACS; Barnes & Olson, 1985; Prado et al., 2007; α = .85). Participants are asked to indicate on a 4-point scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the extent to which they agree with a series of 16 statements (e.g., I can discuss my beliefs with my child without feeling embarrassed). Higher scores indicate a better outcome. Responses on the items were averaged together.	Baseline and Week 4
Change From Baseline in Child Report of Parent-child Communication Quality at Week 4	Parent-child communication quality will be adapted from the 16-item Parent-Adolescent Communication Scale (PACS; Barnes & Olson, 1985; Prado et al., 2007; α = .85). Participants are asked to indicate on a 4-point scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the extent to which they agree with a series of 16 statements (e.g., I can discuss my beliefs with my parent without feeling embarrassed). Higher scores indicate a better outcome. Responses were averaged together.	Baseline and Week 4
Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4	Parent-child communication behaviors about substance use will be assessed by asking a series of 5 questions to assess the frequency of parent-child communication about alcohol, tobacco, vaping, marijuana, and prescription drugs (e.g., How much have you talked with your child about alcohol use?; 5-point Likert-type scale ranging from 1=Never to 5=Extremely Much). Adapted from adapted from Miller-Day & Kam (2010). Higher values indicate a better outcome. Responses were averaged together.	Baseline and Week 4
Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4	Parent-child communication behaviors about substance use will be assessed by asking a series of 5 questions to assess the frequency of parent-child communication about alcohol, tobacco, vaping, marijuana, and prescription drugs (e.g., How much has your parent talked with you about alcohol use?; 5-point Likert-type scale ranging from 1=Never to 5=Extremely Much). Adapted from adapted from Miller-Day & Kam (2010). Higher values indicate a better outcome. Responses were averaged together.	Baseline and Week 4
Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4	Parents' use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do you tell your child that what they see in media (like movies/TV, commercials, social media, and online content like YouTube) is different than real life?) measured on a 5-point Likert-type scale (1=Never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together.	Baseline and Week 4
Change From Baseline in Child Report of Parental Active Media Mediation at Week 4	Child report of parent's use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). Child report of parent use of active media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do your parents tell you that what they see in media (like movies/TV, commercials, social media, and online content like YouTube) is different than real life?) measured on a 5-point Likert-type scale (1=Never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together.	Baseline and Week 4
Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4	Parents' use of restrictive media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013).The scale consists of four items (e.g., How often do you limit the amount of your child's screen time (watching shows, going online, playing video games, or using social media?) measured on a 5-point Likert-type scale (1=never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together.	Baseline and Week 4
Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4	Child report of parent's use of restrictive media mediation strategies will be assessed using an adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). The scale consists of four items (e.g., How often do your parents tell you that you are not allowed to watch certain TV shows or movies because they are meant for adults?) measured on a 5-point Likert-type scale (1=never; 2=almost never; 3=sometimes; 4=often; 5=very often). Higher scores indicate a better outcome. Responses were averaged together.	Baseline and Week 4
Change From Baseline in Child Substance Use Intentions at Week 4	Substance use intentions will be assessed by asking "During the next year, do you think you will drink alcohol" (4-point scale; 1=I definitely will not; 2=I probably will not; 3=I probably will; 4=I definitely will; higher scores indicate a worse outcome). Questions will also be asked for use of tobacco, vape, marijuana, and prescription drugs without a prescription, for a total of 5 questions. Responses were averaged together and then dichotomized. Any participant with a mean of one ("I definitely will not") was rescored as "0" (no intentions) and any participant with a mean greater than one was rescored as "1" (any intentions). A rescored value of "1" indicated a worse outcome. Outcome measure type ("number") indicates the percentage of people who had a rescored value of "1" ("any intentions").	Baseline and Week 4
Change From Baseline in Child Willingness to Use Substances at Week 4	Willingness to use substances will be assessed by asking "Suppose you were with a group of kids and they were drinking alcohol. How willing would you be to have a drink?" (4-point scale; 1=very unwilling; 2=unwilling; 3=willing; 4=very willing). Questions will also be asked for smoking, vaping, marijuana, and taking prescription drugs without a prescription. A total of 5 question will be asked, one for each substance type. Higher scores indicate a worse outcome. Responses were averaged.	Baseline and Week 4

Collaborators and Investigators

• Sponsor: Innovation Research & Training
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: MiddleYearsStudyR21-23-003-001; 5R21DA052737-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No