Back to resultsFeasibility Study of a Web-based Program to Help Parents of Middle School Students Effectively Communicate With Their Children About Substance Use
Primary Purpose
Substance Use, Parenting, Communication
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Media Ready Parent
Active Control Program
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use
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.
Sites / Locations
- innovation Research and TrainingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Web-based intervention
Active Control Program
Arm Description
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.
The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
Outcomes
Primary Outcome Measures
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).
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).
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.
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.
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 (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).
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 (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).
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05900115
First Posted
June 2, 2023
Last Updated
August 23, 2023
Sponsor
Innovation Research & Training
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05900115
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovation Research & Training
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Parenting, Communication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will not be informed which condition they are assigned (intervention or active control). All measures are assessed using a web-based data collection system rather than a human outcomes assessor.
Allocation
Randomized
Enrollment
572 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Web-based intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control Program
Arm Type
Active Comparator
Arm Description
The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
Intervention Type
Behavioral
Intervention Name(s)
Media Ready Parent
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control Program
Intervention Description
The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
Primary Outcome Measure Information:
Title
Change from baseline in parent report of parent-child substance use communication behaviors at Week 4
Description
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).
Time Frame
Baseline and Week 4
Title
Change from baseline in child report of parent-child substance use communication behaviors at Week 4
Description
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).
Time Frame
Baseline and Week 4
Title
Change from baseline in parent report of parental media mediation at Week 4
Description
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.
Time Frame
Baseline and Week 4
Title
Change from baseline in child report of parental media mediation at Week 4
Description
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.
Time Frame
Baseline and Week 4
Title
Change from baseline in parent report of parent-child communication quality at Week 4
Description
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 (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).
Time Frame
Baseline and Week 4
Title
Change from baseline in child report of parent-child communication quality at week 4
Description
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 (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).
Time Frame
Baseline and Week 4
Title
Change from baseline in child substance use intentions at Week 4
Description
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.
Time Frame
Baseline and Week 4
Title
Change from baseline in child willingness to use substances at Week 4
Description
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.
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
innovation Research and Training
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy M Scull, PhD
Phone
919-493-7700
Email
tscull@irtinc.us
First Name & Middle Initial & Last Name & Degree
Christina (Malik) Dodson, PhD
Phone
9194937700
Email
cdodson@irtinc.us
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of a Web-based Program to Help Parents of Middle School Students Effectively Communicate With Their Children About Substance Use
We'll reach out to this number within 24 hrs