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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03881397
Other study ID # 2018-0787
Secondary ID A536760SMPH/PEDI
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2019
Est. completion date February 26, 2020

Study information

Verified date November 2020
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1520
Est. completion date February 26, 2020
Est. primary completion date October 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 17 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States University of Wisconsin Madison Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Facebook, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in physical activity 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. 2 and 4 months after initial baseline (Time 2 and 3)
Primary Technology and Media Use Rules Increases in the number of positive responses to technology and media rules followed or maintained 4 months after initial baseline
Secondary Changes in sleep behavior 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 and 4 months after initial baseline (Time 2 and 3)
Secondary Changes in risk for Problematic Internet Use 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. 2 and 4 months after initial baseline (Time 2 and 3)
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