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NCT02011438 · ClinicalTrials.gov registry record · Phase 2
Coping With Adolescent Peer Victimization and Reducing Anxious/Depressed Symptoms
A Phase 2 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT02011438 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 49 participants.
The verdict
NCT02011438, a Phase 2 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
Among adolescents, SAD and depression are prevalent, highly comorbid, and can be chronic and impairing. Interpersonal peer victimization (IPV) is a key stressor that contributes to both social anxiety and depression in adolescents; it includes relational (e.g., social exclusion) and reputational (e.g., spreading rumors) forms of peer victimization. Currently, there are no preventive interventions for adolescent SAD. Also, effective preventive interventions for adolescents have not yet integrated a focus on both social anxiety and depression or targeted specific peer risk factors. Interventions for depression and for bullying have not addressed IPV, which is less observable than overt victimization (e.g., threats, physical acts). Thus, the Peers Emotions and Relationships (PEERS/UTalk) intervention, will take an integrated approach to reducing risk for SAD and depression by modifying and adapting an evidence-based intervention for depression, Interpersonal Psychotherapy- Adolescents Skills Training (IPT-AST), that focuses on improving interpersonal skills and managing conflict. We will add a) elements of anxiety-based treatments (e.g., exposures) and b) strategies for handling challenging peer experiences. PEERS/UTalk will have a positive focus and will target adolescents who report elevated symptoms of social anxiety and/or depression and high levels of IPV. Following are the aims and hypotheses of the Pilot-Randomized Controlled Trial: Aim: Evaluate PEERS/UTalk. We will screen adolescents and conduct a pilot randomized trial of PEERS (U Talk) versus an Education/Support (ES) condition with up to 60 "high-risk" adolescents. Hypothesis 1: Both PEERS/UTalk and ES conditions will demonstrate: (a) feasibility via rates of participation and study completion, (b) intervention credibility via adolescents' ratings of acceptability and satisfaction, and (c) high rates of clinician fidelity to the respective manuals. Hypothesis 2: Adolescents randomized to PEERS/UTalk wi
Interventions
- BEHAVIORAL UTalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02011438
The ClinicalTrials.gov registry entry for NCT02011438 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which UTalk is the first listed.
NCT02011438 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02011438 about?
NCT02011438 is a clinical study titled "Coping With Adolescent Peer Victimization and Reducing Anxious/Depressed Symptoms". Among adolescents, SAD and depression are prevalent, highly comorbid, and can be chronic and impairing. Interpersonal peer victimization (IPV) is a key stressor that contributes to both social anxiety and depression in adolescents; it includes relational (e.g., social exclusion) and reputational (e....
What is the current status of trial NCT02011438?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2012-06. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02011438?
The interventions under investigation include: UTalk (BEHAVIORAL).
Who is sponsoring clinical trial NCT02011438?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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