SleepNCT03881397
Youth Health and Social Media
A study testing Family Media Use Plan and Media Use Resources Awareness in people with Sleep and Physical Activity, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Physical Activity, Family and Household
- What is being tested?
- Family Media Use Plan and Media Use Resources Awareness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,520 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Madison
Madison, Wisconsin, 53705
About this study
Official title: Youth Health and Social Media: Objective 2 Pilot Intervention
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.
Read the 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.
- Conditions
- Sleep, Physical Activity, Family and Household, Computer, Attitude to, Adolescent Behavior
- Being tested
- Family Media Use Plan, Media Use Resources Awareness
- Keywords
- internet, social media, family rules
- Medical subject headings
- Motor Activity, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Media Use PlanBehavioural
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 AwarenessBehavioural
Resources offered to parents and teens that include tools and publicly available resources for safe technology use among teens
| Study group | Role | What they receive |
|---|---|---|
| Control (Track B assessed at Time 2) | No intervention | A survey regarding tech use, health behaviors and well-being including physical activity, anxiety, and sleep |
| Online Family Media Use Plan (Track A) | Experimental | 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. Receives: Behavioral: Family Media Use Plan |
| Media Use Resources Awareness (Track B assessed at Time 3) | Experimental | Resources offered to parents and teens that include tools and data for safe technology use among teens Receives: Behavioral: Media Use Resources Awareness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technology and Media Use Rules
Increases in the number of positive responses to technology and media rules followed or maintained
Measured: 4 months after initial baseline
Secondary outcomes (2)
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.
Measured: 2 and 4 months after initial baseline (Time 2 and 3)
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.
Measured: 2 and 4 months after initial baseline (Time 2 and 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start4 Apr 2019
- Primary completion1 Oct 2019
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- 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)
- Enrolment
- 1,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Facebook, Inc.
- Responsible party
- Sponsor
- Investigators
- Megan Moreno, MD, MPH, MSeD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881397
- Sponsor's protocol ID
- 2018-0787
- Other IDs
- A536760, SMPH/PEDIATRICS/GPAM
- Status last verified
- Nov 2020
- First submitted
- 21 Jun 2018
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreno MA, Binger KS, Zhao Q, Eickhoff JC. Effect of a Family Media Use Plan on Media Rule Engagement Among Adolescents: A Randomized Clinical Trial. JAMA Pediatr. 2021 Apr 1;175(4):351-358. doi: 10.1001/jamapediatrics.2020.5629.
PubMed 33492346
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Health and Social Media: Objective 2 Pilot Intervention
- ClinicalTrials.gov ID
- NCT03881397
- Acronym / sponsor ID
- 2018-0787
- Conditions
- Sleep, Physical Activity, Family and Household, Computer, Attitude to, Adolescent Behavior
- Keywords
- internet, social media, family rules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,520 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Facebook, Inc.
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Control (Track B assessed at Time 2) | No intervention | –A survey regarding tech use, health behaviors and well-being including physical activity, anxiety, and sleep |
| Online Family Media Use Plan (Track A) | Experimental | Behavioral: Family Media Use PlanThe 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. |
| Media Use Resources Awareness (Track B assessed at Time 3) | Experimental | Behavioral: Media Use Resources AwarenessResources offered to parents and teens that include tools and data for safe technology use among teens |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Family Media Use PlanA 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. | Behavioural | Online Family Media Use Plan (Track A) |
| Media Use Resources AwarenessResources offered to parents and teens that include tools and publicly available resources for safe technology use among teens | Behavioural | Media Use Resources Awareness (Track B assessed at Time 3) |
Primary outcome
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
2 secondary outcomes
Changes in sleep behavior
Time frame: 2 and 4 months after initial baseline (Time 2 and 3)
Changes in risk for Problematic Internet Use
Time frame: 2 and 4 months after initial baseline (Time 2 and 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Derived from this study: PubMed 33492346Moreno MA, Binger KS, Zhao Q, Eickhoff JC. Effect of a Family Media Use Plan on Media Rule Engagement Among Adolescents: A Randomized Clinical Trial. JAMA Pediatr. 2021 Apr 1;175(4):351-358. doi: 10.1001/jamapediatrics.2020.5629.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Megan Moreno, MD, MPH, MSeD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Media Use Plan and Media Use Resources Awareness in people with Sleep and Physical Activity, run by University of Wisconsin, Madison 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 2 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 27 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technology and Media Use Rules (time frame: 4 months after initial baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881397, which also lists 1 linked publication.
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 27 Nov 2020.