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
2 other identifiers
interventional
576
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2023
CompletedFirst Submitted
Initial submission to the registry
June 2, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2023
CompletedResults Posted
Study results publicly available
October 23, 2024
CompletedOctober 23, 2024
September 1, 2024
7 months
June 2, 2023
July 3, 2024
October 1, 2024
Conditions
Outcome Measures
Primary Outcomes (10)
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
Study Arms (2)
Web-based intervention
EXPERIMENTALThe 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
ACTIVE COMPARATORThe active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
innovation Research and Training
Durham, North Carolina, 27713, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tracy Scull, PhD
- Organization
- innovation Research & Training
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2023
First Posted
June 12, 2023
Study Start
May 8, 2023
Primary Completion
November 29, 2023
Study Completion
November 29, 2023
Last Updated
October 23, 2024
Results First Posted
October 23, 2024
Record last verified: 2024-09