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

Parenting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05900115
• Other study ID #: MiddleYearsStudyR21-23-003-001
• Secondary ID: 5R21DA052737-02
• Status: Completed
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: November 21, 2023

Study information

• Verified date: May 2024
• Source: Innovation Research & Training
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communication
• Parenting
• Substance Use
• Substance-Related Disorders

Intervention

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 Control Program
The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.

Locations

Country	Name	City	State
United States	innovation Research and Training	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Innovation Research & Training	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in parent report of parent-child substance use communication behaviors at Week 4	Parent-child communication behaviors about substance use will be assessed by asking a series of questions to assess the frequency and type of communication about alcohol, tobacco, vaping, marijuana, and prescription drugs. Adapted from adapted from Miller-Day & Kam (2010).	Baseline and Week 4
Primary	Change from baseline in child report of parent-child substance use communication behaviors at Week 4	Parent-child communication behaviors about substance use will be assessed by asking a series of questions to assess the frequency and type of communication about alcohol, tobacco, vaping, marijuana, and prescription drugs. Adapted from adapted from Miller-Day & Kam (2010).	Baseline and Week 4
Primary	Change from baseline in parent report of parental media mediation at Week 4	Parents' use of media mediation strategies will be assessed using a adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). This measures assesses both restrictive and active media mediation.	Baseline and Week 4
Primary	Change from baseline in child report of parental media mediation at Week 4	Parents' use of media mediation strategies will be assessed using a adapted version of the Perceived Parental Media Mediation Scale (Valkenberg et al., 2013). This measures assesses both restrictive and active media mediation.	Baseline and Week 4
Primary	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; a = .85). Participants are asked to indicate on a 4-point scale (strongly disagree; disagree; agree; 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).	Baseline and Week 4
Primary	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; a = .85). Participants are asked to indicate on a 4-point scale (strongly disagree; disagree; agree; 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).	Baseline and Week 4
Primary	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; I definitely will not - I definitely will). Questions will also be asked for use tobacco, vape, use marijuana, and use prescription drugs without a prescription.	Baseline and Week 4
Primary	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; Very unwilling - Very willing). Questions will also be asked for smoking, vaping, smoking marijuana, and taking prescription drugs without a prescription.	Baseline and Week 4