- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07936890
CYOA App Intervention for Social Media Use in Adolescents With Depression (CYOA)
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Kathryn R. Cullen, MD
- Telefonnummer: 612-624-3403
- E-mail: rega0026@umn.edu
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota Masonic Institute for the Developing Brain
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Kontakt:
- Kathryn R Cullen, MD
- Telefonnummer: 612-624-3403
- E-mail: rega0026@umn.edu
-
Ledende efterforsker:
- Kathryn R Cullen, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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. |
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.
Andre navne:
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Ingen indgriben: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CYOA App Use During Intervention Period
Tidsramme: 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
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Acceptability of the CYOA App
Tidsramme: Post-intervention visit, after the 2-week intervention period
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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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Social Media Use Patterns
Tidsramme: 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
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Daily Mood
Tidsramme: Twice daily during the 2-week intervention period
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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
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Sleep
Tidsramme: Baseline, post-intervention after 2 weeks, and 3-month follow-up; daily during the 2-week intervention period
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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
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Physical Activity
Tidsramme: Baseline, post-intervention after 2 weeks, and 3-month follow-up; daily during the 2-week intervention period
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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
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Number of In-Person Social Interactions
Tidsramme: Daily during the 2-week intervention period.
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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.
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Duration of In-Person Social Interactions
Tidsramme: Daily during the 2-week intervention period.
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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.
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Anxiety Symptoms
Tidsramme: Daily during the 2-week intervention period.
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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.
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Well-Being as Measured by the Flourishing Scale
Tidsramme: Baseline, post-intervention at 2 weeks, and 3-month follow-up
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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
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Well-Being as Measured by the Satisfaction with Life Scale
Tidsramme: Baseline, post-intervention at 2 weeks, and 3-month follow-up
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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
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Social Connectedness
Tidsramme: Baseline, post-intervention after 2 weeks, and 3-month follow-up
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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
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Depression Symptoms - CDI-2 Child-Report
Tidsramme: Baseline, post-intervention at 2 weeks, and 3-month follow-up
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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
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Depression Symptoms - CDI-2 Parent-Report
Tidsramme: Baseline, post-intervention at 2 weeks, and 3-month follow-up
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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
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Change in Social Media Self-Control Failure
Tidsramme: Baseline, post-intervention after 2 weeks, and 3-month follow-up
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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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kathryn R. Cullen, MD, University of Minnesota
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PSYCH-2026-35108
- R21MH145210 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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