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CYOA App Intervention for Social Media Use in Adolescents With Depression (CYOA)

9 novembre 2026 aggiornato da: University of Minnesota

Choose Your Own Adventure: A Novel Intervention to Regulate Social Media Use in Adolescents With Depression

This study will develop and test Choose Your Own Adventure, a personalized app-based intervention designed to help adolescents with depression regulate social media use.

Adolescents ages 13 to 17 years with major depressive disorder and daily TikTok use will be randomized to either the CYOA app intervention or no intervention. The CYOA app is designed to detect individualized patterns of problematic social media use and offer personalized options to disrupt "runaway train" social media use.

The study will assess feasibility, acceptability, preliminary effects on social media use and mood, and potential mechanisms including social media self-control failure. Participants will complete baseline, post-intervention, and 3-month follow-up assessments.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Choose Your Own Adventure is a pilot randomized controlled clinical trial testing a personalized app-based intervention to regulate social media use in adolescents with depression.

The study will enroll 60 adolescents ages 13 to 17 years with major depressive disorder. Participants will be randomized 1:1 to the CYOA app intervention or no intervention. The intervention is designed to promote adolescent agency rather than force discontinuation of social media use. Adolescents assigned to CYOA will identify situations that may be harmful to their well-being and select preferred options for what to do when those situations arise.

The app will sense and characterize social media content and engagement patterns. When it detects a predefined "runaway train" social media use pattern, it will offer personalized options based on the adolescent's plan. Options may include pausing after a specified time or number of videos, modifying sensory intensity, engaging in a mindfulness activity, or editing the feed to remove topics the adolescent identifies as problematic.

Participants in both groups will download the study app and use it for 2 weeks. Adolescents will complete ecological momentary assessment prompts twice daily during the 2-week period. Baseline, post-intervention, and 3-month follow-up assessments will evaluate depression symptoms, anxiety, well-being, social connectedness, sleep, physical activity, social media self-control failure, and social media use patterns.

The main goals are to assess feasibility, acceptability, preliminary impact, and potential mechanisms of the CYOA intervention compared with no intervention.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Kathryn R. Cullen, MD
  • Numero di telefono: 612-624-3403
  • Email: rega0026@umn.edu

Luoghi di studio

  • Stati Uniti
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • University of Minnesota Masonic Institute for the Developing Brain
        • Contatto:
        • Investigatore principale:
          • Kathryn R Cullen, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 13 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age 13 to 17 years
  • Presence of major depressive disorder, with a current episode of at least 2 months
  • Adolescent and parent or guardian speak English
  • Adolescent is a current user of social media on a personal cell phone
  • Adolescent uses English-language TikTok for at least 2 hours per day on average

Exclusion Criteria:

  • Primary psychotic disorder, bipolar disorder, or neurodevelopmental disorder
  • Parent or guardian or child does not speak English
  • Adolescent does not own a personal cell phone
  • Adolescent does not use social media, specifically TikTok, at least 2 hours per day
  • Fetuses
  • Neonates
  • Prisoners
  • Adults lacking capacity to consent or adults with diminished capacity to consent
  • Non-English speakers
  • Individuals unable to read
  • Employees of the researcher
  • Students of the researcher
  • Active members of the military or DoD personnel
  • Individuals approached for research participation during a stressful situation, such as an emergency room setting or childbirth

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Choose Your Own Adventure App

Adolescents randomized to this arm will use the CYOA app for 2 weeks. The app is designed to detect individualized social media use patterns and offer personalized options to disrupt problematic "runaway train" social media use.
Comportamentale: Choose Your Own Adventure App

The CYOA app is a personalized social media self-regulation intervention for adolescents with depression. Adolescents identify social media situations that may be harmful to their well-being and select preferred options for responding when those situations arise. When the app detects a "runaway train" social media use pattern based on predefined thresholds, it offers personalized options such as pausing use, modifying sensory intensity, engaging in mindfulness, or editing the feed to remove problematic content.

Altri nomi:
  • CYOA App
Nessun intervento: No Intervention

Adolescents randomized to this arm will use social media as much or as little as preferred during the 2-week study period. They will still use the study app for data collection and complete the same study assessments as the intervention group.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
CYOA App Use During Intervention Period
Lasso di tempo: During the 2-week intervention period

Feasibility will be assessed by the number and proportion of days, out of 14 days, that adolescents assigned to the CYOA app use the intervention. The feasibility target is use of the app on at least 8 of 14 days.
During the 2-week intervention period
Acceptability of the CYOA App
Lasso di tempo: Post-intervention visit, after the 2-week intervention period

Acceptability will be assessed using adapted Treatment Acceptability/Adherence Scale ratings with adolescents assigned to CYOA. Total score ranges from 9 to 63; higher scores indicate greater treatment acceptability/adherence. Create a separate outcome for qualitative interviews only if they are intended to be reported as an outcome, with a defined reporting measure.
Post-intervention visit, after the 2-week intervention period

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Social Media Use Patterns
Lasso di tempo: During the 2-week intervention period

Social media use patterns will be assessed using data extracted by the study app, including engagement patterns and app-based social media use data, and by self-report using the Social Media Use Scale. Social media use will be assessed using the Social Media Use Scale (SMUS). Total scores range from 17 to 153; higher scores indicate worse outcomes." Move app-derived engagement patterns into separate outcome entries once their specific measures are defined.
During the 2-week intervention period
Daily Mood
Lasso di tempo: Twice daily during the 2-week intervention period

Daily mood will be assessed using ecological momentary assessment prompts with items from the Positive and Negative Affect Schedule short form.
Twice daily during the 2-week intervention period
Sleep
Lasso di tempo: Baseline, post-intervention after 2 weeks, and 3-month follow-up; daily during the 2-week intervention period

Sleep will be assessed using the Pittsburgh Sleep Quality Index at study visits and daily ecological momentary assessment of hours slept during the 2-week intervention period. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21; higher scores indicate worse sleep quality." Separate daily EMA hours slept.
Baseline, post-intervention after 2 weeks, and 3-month follow-up; daily during the 2-week intervention period
Physical Activity
Lasso di tempo: Baseline, post-intervention after 2 weeks, and 3-month follow-up; daily during the 2-week intervention period

Physical activity will be assessed using the Moderate to Vigorous Physical Activity screening measure and daily ecological momentary assessment of minutes of physical activity. Physical activity will be assessed using the Moderate to Vigorous Physical Activity (MVPA) screening measure. Scores range from 0 to 7; higher scores indicate better outcomes.
Baseline, post-intervention after 2 weeks, and 3-month follow-up; daily during the 2-week intervention period
Number of In-Person Social Interactions
Lasso di tempo: Daily during the 2-week intervention period.

The number of meaningful in-person social interactions will be assessed using daily ecological momentary assessment (EMA) questions during the intervention period.
Daily during the 2-week intervention period.
Duration of In-Person Social Interactions
Lasso di tempo: Daily during the 2-week intervention period.

The duration of meaningful in-person social interactions will be assessed using daily ecological momentary assessment (EMA) questions during the intervention period.
Daily during the 2-week intervention period.
Anxiety Symptoms
Lasso di tempo: Daily during the 2-week intervention period.

Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 scale.Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21; higher scores indicate greater anxiety symptom severity.
Daily during the 2-week intervention period.
Well-Being as Measured by the Flourishing Scale
Lasso di tempo: Baseline, post-intervention at 2 weeks, and 3-month follow-up

Well-being will be assessed using the Flourishing Scale (FS). Total scores range from 8 to 56, with higher scores indicating greater well-being.
Baseline, post-intervention at 2 weeks, and 3-month follow-up
Well-Being as Measured by the Satisfaction with Life Scale
Lasso di tempo: Baseline, post-intervention at 2 weeks, and 3-month follow-up

Well-being will be assessed using the Satisfaction with Life Scale (SWLS). Total scores range from 5 to 35, with higher scores indicating greater life satisfaction.
Baseline, post-intervention at 2 weeks, and 3-month follow-up
Social Connectedness
Lasso di tempo: Baseline, post-intervention after 2 weeks, and 3-month follow-up

Social connectedness will be assessed using the Social Connectedness Scale-Revised. Social connectedness will be assessed using the Social Connectedness Scale-Revised (SCS-R). Scores range from 0 to 6; higher scores indicate greater social connectedness
Baseline, post-intervention after 2 weeks, and 3-month follow-up
Depression Symptoms - CDI-2 Child-Report
Lasso di tempo: Baseline, post-intervention at 2 weeks, and 3-month follow-up

Depression symptoms will be assessed using the Children's Depression Inventory-2 (CDI-2), Child-Report. Scores range from 0 to 56; higher scores indicate greater depressive symptom severity.
Baseline, post-intervention at 2 weeks, and 3-month follow-up
Depression Symptoms - CDI-2 Parent-Report
Lasso di tempo: Baseline, post-intervention at 2 weeks, and 3-month follow-up

Depression symptoms will be assessed using the Children's Depression Inventory-2 (CDI-2), Parent-Report. Scores range from 0 to 51; higher scores indicate greater depressive symptom severity.
Baseline, post-intervention at 2 weeks, and 3-month follow-up
Change in Social Media Self-Control Failure
Lasso di tempo: Baseline, post-intervention after 2 weeks, and 3-month follow-up

Social media self-control failure will be assessed using the Social Media Self Control Failure scale. The study will evaluate whether CYOA is associated with greater decreases in social media self-control failure compared with no intervention. Social media self-control failure will be assessed using the Social Media Self Control Failure (SMSCF) Scale. Scores range from 3 to 15; higher scores indicate worse self-control failure.
Baseline, post-intervention after 2 weeks, and 3-month follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Minnesota

Collaboratori

National Institute of Mental Health (NIMH)

Investigatori

  • Investigatore principale: Kathryn R. Cullen, MD, University of Minnesota

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2027

Completamento primario (Stimato)

10 ottobre 2029

Completamento dello studio (Stimato)

10 ottobre 2030

Date di iscrizione allo studio

Primo inviato

21 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PSYCH-2026-35108
  • R21MH145210 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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