Technology Exposure and Child Health: Wellness Impact and Social Effects: an Observational Product Registry Study

NCT ID: NCT06664944

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-12-31

Brief Summary

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The goal of this study is to understand how children's mobile device usage (smartphones or tablets), including social media use and online games, are related to their mental wellness and mental health, as well as some aspects of their physical activity and sleep. This study is available to all children between the ages of 8 and 17 years and a parent/caregiver.

Researchers will compare participant mobile device usage with their survey responses on sleep, stress, mental health, and physical activity, as well as their parent/caregiver's survey responses.

Participants will:

* run the Aura app with parental controls on their dedicated mobile device
* complete monthly surveys
* answer daily questions on mood, stress, sleep and physical activity

The study is fully virtual. Duration is 3 months.

Detailed Description

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Once enrolled, child participants will use their mobile devices as usual, and Aura will collect data on on-line and off-line activity, app usage, social interaction, sleep, location and activity levels.

The child participant will complete surveys on a monthly basis, including:

* A range of questionnaires about feelings and behaviors that are associated with mental health challenges
* Questionnaires that ask about well-being and positive feelings, including relationships with family and friends
* Questionnaires that ask about experiences with social media and device usage
* A questionnaire about feelings of loneliness
* A questionnaire that asks about activity sleep

In parallel, the parent participant will complete monthly surveys about the child, including:

* Medical history and changes
* A range of questionnaires about feelings and behaviors that are associated with mental health challenges
* Questionnaires that ask about well-being and positive feelings, including relationships with family and friends

Conditions

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Mood Depression Disorders Anxiety Disorders Sleep Eating Disorders Physical Activity Loneliness Stress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children 8-17 years old

Over 84% of children ages 8 and up have access to a mobile device (smartphone, tablet) and are active on social media. This study focuses on children ages 8-17 to better understand social media usage and how it relates to their mental well-being.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Child participants are male, female, non-binary persons, ages 8-17, inclusive
2. Parent/Authorized Legal Guardian willing to provide informed consent; child willing to provide assent
3. Both Parent/Authorized Legal Guardian and child own a mobile device that already has the Aura app or is able to install and run the Aura app, and the appropriate parental control features.
4. Parent/Authorized Legal Guardian and child are willing for child to use a dedicated device for the duration of the study (ie., child cannot share device with a sibling or other family member).
5. Multiple children from the same family are eligible to participate, provided that each enrolled child uses a dedicated device AND is able to complete outcome assessments independently, AND that parent/authorized legal guardian is able to complete assessments for each enrolled child.
6. Both Parent/Authorized Legal Guardian and child willing to share data collected as part of the Aura app and related device applications
7. Consented Parent/Authorized Legal Guardian and child maintain active Aura accounts throughout their study participation
8. Consented Parent/Authorized Legal Guardian and child are able to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
9. Consented Parent/Authorized Legal Guardian and child are to comply with all testing and study requirements
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aura

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Kollins, Doctorate in Psychology

Role: PRINCIPAL_INVESTIGATOR

Aura

Locations

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Aura

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karen Goetz

Role: CONTACT

8665797576

Karen Goetz

Role: CONTACT

9195258699

Facility Contacts

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Project Manager

Role: primary

866-579-7576

References

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Kollins SH, Flannery J, Goetz K, Akre-Bhide S. Technology Effects and Child Health: Wellness Impact and Social Effects (TECHWISE): Protocol for a Prospective, Observational, Real-World Study. JMIR Res Protoc. 2025 Jun 19;14:e69358. doi: 10.2196/69358.

Reference Type DERIVED
PMID: 40424191 (View on PubMed)

Other Identifiers

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20243405

Identifier Type: -

Identifier Source: org_study_id

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