Clinical trial NCT06664944: Technology Exposure and Child Health: Wellness Impact and Social Effects: an Observational Product Registry Study
Official title: Technology Exposure and Child Health: Wellness Impact and Social Effects (TECHWISE): an Observational Product Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mood
Depression Disorders
Anxiety Disorders
Sleep
Eating Disorders
Physical Activity
Loneliness
Stress
Keywords: digital health
digital mental health
technology impacts on mental health
digital natives
digital parenthood
child online safety
digital wellness
child online well-being
Lead sponsor: Aura
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US-based, English-speaking, parents and children who use mobile devices for social media and online games.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Assess ongoing technology use to explore children's online behaviors and derived health behaviors.
timeFrame: December 2025
Secondary outcomes:
measure: Examine bivariate associations between technology use features and mental wellness and mental health outcomes
timeFrame: December 2025
measure: Develop preliminary predictive models that use technology use and smartphone-derived parameters to predict point-in-time mental health outcomes
timeFrame: December 2025
Other outcomes:
Locations:
city: Boston
country: United States
facility: Aura
state: Massachusetts
Study officials:
affiliation: Aura
name: Scott Kollins, Doctorate in Psychology
role: PRINCIPAL_INVESTIGATOR
References: