Social Media Usage in Adolescent Girls

NCT ID: NCT06426459

Last Updated: 2024-05-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-29

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to explore the effects of hormonal fluctuations throughout the menstrual cycle on social media use, brain architecture, neural reward processing and reward behavior, and affective status in adolescent girls. Additionally, it strives to compare the effects of exogenous and endogenous hormones on the above-mentioned aspects. For this purpose, the investigators will compare two main groups in the study: 1. Naturally cycling adolescent girls, 2. Adolescent girls using combined oral contraceptives. This study will combine self-report data via questionnaires, ecological data via Ecological Momentary Assessment (EMA), endocrine data via blood collection, and neural data via fMRI assessment to enhance the understanding of the neurobiological mechanisms underlying social media use in adolescent girls. Furthermore, it seeks to elucidate whether there are vulnerable periods throughout the menstrual cycle when adolescent girls are especially prone to dysfunctional social media use and help to design more specific interventions as well as therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

For each participant, there is a screening session, a month-long EMA assessment and two experimental fMRI sessions are planned.

After making sure the participants fill the inclusion and exclusion criteria, the investigators will invite them to the laboratory for a screening session (T0). In this session, the participants will provide written informed consent and assent in case of those under 18 years old and written, informed consent for those who are 18 year old. Furthermore, the participants will participate in a standardized clinical interview to screen for mental disorders (Kinder-DIPS). Subsequently, they will be informed about the study details. Finally, they will fill out questionnaires about personality, depressive symptoms, anxiety symptoms, gender identity and norms, mood, loneliness, social media disorder, internet use, social support, and fear of missing out.

Naturally cycling adolescent girls will join the two fMRI measurements (T1 \& T2) during the follicular and luteal phase of the menstrual cycle. Adolescent girls using combined oral contraceptives will join the first fMRI measurement during the pill intake period, and the second measurement during the break period. The fMRI sessions will comprise of filling out questionnaires, fMRI measurements, and blood collection for hormonal assessment.

Questionnaires on depressive symptoms, state anxiety, mood, gender identity, self-esteem, loneliness, fear of missing out (FOMO), social media disorder, internet use, social support and social media use will be administered through RedCap platform. This will ensure the assessment of subjective, self-report data and its changes throughout the measurement time of one month.

The sequence of fMRI measurements incudes four main parts, namely anatomical scan, resting-state scan, Effort Allocation Task (EAT), and diffusion tensor imaging (DTI). This protocol ensures the acquisition of the structural and functional data of the brain in the participants. The detailed protocol components are as follows:

1. Anatomical scan: This first sequence of the protocol ensures assessment and insight into the anatomy of the brain, thus providing structural data of the participants' brain. This will last approximately 8 minutes.
2. Resting-state scan: The next sequence involves participants watching a movie that was designed to improve imaging at rest for approximately 10 minutes. This sequence ensures insight into brain activity when no task is being performed and when the participant is at rest.
3. Effort Allocation Task (EAT): This next sequence aims to assess reward processing and reward behavior in the participants. During this task, participants have to exert physical effort on a grip force device when faced with monetary points at stake. There are two types of reward a participant can face; low and high reward. Additionally, there are two difficulty levels during the task, one being easier and the other more difficult. The payoff for the invested effort will be proportional to its duration. The task will last approximately 17 minutes.
4. Diffusion Tensor Imaging (DTI): During the final sequence, participants will undergo DTI assessment to ensure insight into white matter microstructure and connectivity. This will last approximately 7-8 minutes.

To thoroughly investigate the participants' experiences in their natural environments, Ecological Momentary Assessment (EMA) will be conducted. This will be done through an app called m-Path where participants will fill out daily questionnaires about social media use, self-esteem, premenstrual symptoms, and mood throughout one month. A daily questionnaire lasts approximately 10 minutes. This assessment will ensure data about subjective experiences with high ecological validity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menstrual Cycle Oral Contraceptive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Natural menstrual cycle

Adolescent girls who have a natural menstrual cycle and have not used any kind of hormonal contraception for at least 6 months.

No interventions assigned to this group

Oral contraceptive

Adolescent girls who use combined oral contraceptives for at least 4 months.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between 15 and 18 years old adolescent girls
* Body mass index(18-25kg/m2)
* Natural menstrual cycle (between 25 to 31 days) OR use of combined oral contraceptives for at least 4 months
* Social media use (e.g., Instagram, TikTok, Snapchat, Facebook, X, BeReal)
* Non-smoking
* German language fluency
* Attending age-appropriate school

Exclusion Criteria

* Any neurological or psychiatric disease based on the standardized diagnostic interview (Kinder-DIPS)
* Medical problems such as hormonal, metabolic, developmental or chronic diseases (e.g., congenital disorders, diabetes, dysfunctions of the thyroid, or congestive heart failure)
* Pregnancy
* Females who gave birth or were breastfeeding within the last year
* Use of any other kind of steroid hormonal treatment (except combined oral contraceptives) or psychotropic treatment in the last three months
* Females with premenstrual dysphoric disorder(PMDD)
* Not willing to be informed about incidental fMRI findings


* Individuals with non-removable metal objects on or in the body such as cardiac pacemaker, artificial heart valve, metal prostheses, metal implants, metal splinters, etc.
* Tattoos (if fMRI-incompatible according to expert guidelines)
* Claustrophobia
* Surgery less than three months ago
* Pathological hearing or increased sensitivity to loud noises
* Neurological disease or injury
* Moderate or severe head injury
* Restricted (corrected) vision
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

German Research Foundation

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

International Research Training Group 2804

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tobias Renner, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Child Psychiatry, University Clinic Tübingen

Tomas Furmark, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, Uppsala University, Sweden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Clinic Tuebingen, Department of Psychiatry & Psychotherapy

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Edita Karavidaj, MSc

Role: CONTACT

+491746443856

Isabel Brandhorst, Dr. Dipl.-Psych.

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRTG_P09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stress Reactivity and Hormonal Contraception
NCT06223126 ENROLLING_BY_INVITATION
Sleep and Health Outcomes in Women With Heavy Menses
NCT05722444 ACTIVE_NOT_RECRUITING NA
Sleep Quality and the Menstrual Cycle
NCT06906133 ACTIVE_NOT_RECRUITING
Estradiol and Brain Age
NCT06773429 COMPLETED