Substance UseNCT05900115
Feasibility Study of a Web-based Program to Help Parents of Middle School Students Effectively Communicate With Their Children About Substance Use
A study testing Media Ready Parent in people with Substance Use and Parenting, run by Innovation Research & Training at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Parenting, Communication
- What is being tested?
- Media Ready Parent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
innovation Research and Training
Durham, North Carolina, 27713
About this study
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
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.
Read the 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.
- Conditions
- Substance Use, Parenting, Communication
- Being tested
- Media Ready Parent, Active Control Program
- Medical subject headings
- Substance-Related Disorders, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Media Ready ParentBehavioural
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 ProgramBehavioural
The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use.
| Study group | Role | What they receive |
|---|---|---|
| Web-based intervention | Experimental | 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. Receives: Behavioral: Media Ready Parent |
| Active Control Program | Active comparator | The active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use. Receives: Behavioral: Active Control Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start8 May 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Research & Training
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900115
- Sponsor's protocol ID
- MiddleYearsStudyR21-23-003-001
- Other IDs
- 5R21DA052737-02
- Status last verified
- Sep 2024
- First submitted
- 2 Jun 2023
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05900115
- Acronym / sponsor ID
- MiddleYearsStudyR21-23-003-001
- Conditions
- Substance Use, Parenting, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Innovation Research & TrainingUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based intervention | Experimental | Behavioral: Media Ready ParentThe 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 comparator | Behavioral: Active Control ProgramThe active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Media Ready ParentThe 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. | Behavioural | Web-based intervention |
| Active Control ProgramThe active control is a web-based resource that contains PDFs of medically accurate information about adolescent substance use. | Behavioural | Active Control Program |
Primary outcome
Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4
Time frame: Baseline and 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.
Change From Baseline in Child Report of Parent-child Communication Quality at Week 4
Time frame: Baseline and 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.
Change From Baseline in Parent Report of Parent-child Substance Use Communication Frequency at Week 4
Time frame: Baseline and 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.
Change From Baseline in Child Report of Parent-child Substance Use Communication Frequency at Week 4
Time frame: Baseline and 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.
Change From Baseline in Parent Report of Parental Active Media Mediation at Week 4
Time frame: Baseline and 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.
Change From Baseline in Child Report of Parental Active Media Mediation at Week 4
Time frame: Baseline and 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.
Change From Baseline in Parent Report of Parental Restrictive Media Mediation at Week 4
Time frame: Baseline and 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.
Change From Baseline in Child Report of Parental Restrictive Media Mediation at Week 4
Time frame: Baseline and 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.
Change From Baseline in Child Substance Use Intentions at Week 4
Time frame: Baseline and 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").
Change From Baseline in Child Willingness to Use Substances at Week 4
Time frame: Baseline and 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Media Ready Parent in people with Substance Use and Parenting, run by Innovation Research & Training at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Parent Report of Parent-child Communication Quality at Week 4 (time frame: Baseline and Week 4). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.