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Youth Health and Social Media

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ClinicalTrials.gov Identifier: NCT03881397
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Facebook, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this study is test the American Academy of Pediatrics (AAP) Family Media Use plan among teens and their parents through a randomized intervention and assess impact on outcomes including family media rules and health behavior outcomes.

Condition or disease Intervention/treatment Phase
Sleep Physical Activity Family and Household Computer, Attitude to Adolescent Behavior Behavioral: Family Media Use Plan Behavioral: Media Use Resources Awareness Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Track A will be our intervention group receiving the Family Media Use intervention Track B will serve as control group at Time 2, and then receive an awareness intervention at that time to compare that intervention at Time 3 to Track A at Time 2
Masking: None (Open Label)
Masking Description: This will be an online intervention with interventions pre-determined by tracks, so no masking is needed
Primary Purpose: Prevention
Official Title: Youth Health and Social Media: Objective 2 Pilot Intervention
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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
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.
Behavioral: Family Media Use Plan
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
Behavioral: Media Use Resources Awareness
Resources offered to parents and teens that include tools and publicly available resources for safe technology use among teens




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Changes in risk for Problematic Internet Use [ Time Frame: 2 and 4 months after initial baseline (Time 2 and 3) ]
    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.


Other Outcome Measures:
  1. 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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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881397


Contacts
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Contact: Aubrey Gower 608-262-1776 adgower@wisc.edu
Contact: Megan Moreno, MD, MPH, MSeD moreno@wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Megan Moreno, MD    608-263-2846      
Sponsors and Collaborators
University of Wisconsin, Madison
Facebook, Inc.
Investigators
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Principal Investigator: Megan Moreno, MD, MPH, MSeD University of Wisconsin, Madison

Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03881397     History of Changes
Other Study ID Numbers: 2018-0787
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All data would be de-identified and only shared with appropriate study individuals and collaborators listed on the Institutional Review Board study form

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
internet
social media
family rules