- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03881397
Youth Health and Social Media
Youth Health and Social Media: Objective 2 Pilot Intervention
Study Overview
Status
Intervention / Treatment
Detailed Description
For this study there will be three time points of data collection and participant contact by Qualtrics:
Time 1: Baseline
Participants (teen and parent dyads) will be randomized into one of two tracks:
Track A: Family Media Use Plan intervention Track B: Awareness intervention (delayed start intervention)
The track A group will complete a survey regarding technology rules, tech use, and health behaviors, as well as the Family Media Use Plan embedded into the survey. Track B group will only complete the baseline survey.
Time 2: Follow Up Survey: 4-6 weeks after baseline
Track A group will complete a follow-up survey similar to the baseline with additional follow-up questions around their use of the family media use plan.
The track B group will complete a similar survey and receive the Awareness Intervention, providing resources available regarding youth and media use .
Time 3: Follow Up Survey: 3-4 months after baseline
All participants will be asked to complete their corresponding tracks (track A or track B) survey again to understand use media use and health behaviors change over time.
Track A or B designated questions are labeled within each uploaded survey.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin Madison
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English speaking and between the ages of 12 and 17
- Parents must be English speaking and have a child between the ages of 12 and 17
Exclusion Criteria:
- n/a
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control (Track B assessed at Time 2)
A survey regarding tech use, health behaviors and well-being including physical activity, anxiety, and sleep
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|
Experimental: Online Family Media Use Plan (Track A)
The Online Family Media Use Plan group will receive a link to American Academy of Pediatrics Family Media Use plan at the end of the survey, which describes internet safety ideas for teens and parents to review and create together.
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A tool developed by the American Academy of Pediatrics that engages teens and parent to discuss internet safety ideas and develop rules around technology use together.
|
Experimental: Media Use Resources Awareness (Track B assessed at Time 3)
Resources offered to parents and teens that include tools and data for safe technology use among teens
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Resources offered to parents and teens that include tools and publicly available resources for safe technology use among teens
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technology and Media Use Rules
Time Frame: 4 months after initial baseline
|
Increases in the number of positive responses to technology and media rules followed or maintained
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4 months after initial baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in sleep behavior
Time Frame: 2 and 4 months after initial baseline (Time 2 and 3)
|
Changes in sleep as measured by the 8 item Pediatric Daytime Sleepiness Scale (PDSS).
Participants will assess their sleep behaviors by answering each item with "never", "seldom", "sometimes", "frequently", or "always".
Items are scored from 0-4 (never= 0; seldom=1; sometimes=2; frequently=3; always=4) with a score above 16 indicating poor sleep behavior.
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2 and 4 months after initial baseline (Time 2 and 3)
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Changes in risk for Problematic Internet Use
Time Frame: 2 and 4 months after initial baseline (Time 2 and 3)
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Changes in problematic internet use symptoms as measured by the 18-item Problematic and Risky Internet Use Screening Scale (PRIUSS).
For each item participants will select from "never", "rarely", "sometimes", "often", or "very often" in relation to their internet use over the last 6 months.
Each option is coded with "never" equal to 1 and "very often" equal to 5.
An overall composite score is calculated at the end, with an overall score of 25 indicating a risk for problematic internet use.
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2 and 4 months after initial baseline (Time 2 and 3)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in physical activity
Time Frame: 2 and 4 months after initial baseline (Time 2 and 3)
|
Reported physical activity as measured by the 3 item Physical Activity Scale.
Response options range from never (1) to 4 times or more a week (5) for each item.
Higher scores indicating greater physical activity.
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2 and 4 months after initial baseline (Time 2 and 3)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan Moreno, MD, MPH, MSeD, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018-0787
- A536760 (Other Identifier: UW, Madison)
- SMPH/PEDIATRICS/GPAM (Other Identifier: UW, Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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