Coping With Adolescent Peer Victimization and Reducing Anxious/Depressed Symptoms

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Annette La Greca, PhD, University of Miami
ClinicalTrials.gov Identifier:
NCT02011438
First received: June 7, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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 will show improvements in primary outcomes (less IPV, fewer symptoms of social anxiety and depression, improved clinician ratings) relative to those in the ES condition.

Hypothesis 3: The benefits of PEERS/UTalk over ES will be apparent on the secondary outcomes of increased quality of close friendships, increased peer support.

Exploratory Aims: We will examine: (1) the durability and persistence of PEERS/UTalk intervention effects versus ES on primary outcomes at 6-month follow-up and (2) potential moderators of response to the PEERS/UTalk intervention, recognizing that there are power limitations in doing so.


Condition Intervention Phase
Depression
Social Anxiety
Behavioral: UTalk
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Coping With Adolescent Peer Victimization and Reducing Anxious/Depressed Symptoms

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Anxiety Disorder Interview Schedule- Children (ADIS-C) [ Time Frame: Baseline, Change from baseline in Clinician Severity Rating at 12 weeks and at 6 month follow up for Social Anxiety Disorder and Major Depressive Disorder ] [ Designated as safety issue: No ]
  • Clinicians Global Impression Scale (Severity and Improvement) [ Time Frame: Baseline, Change from baseline at 12 weeks, and at 6 month follow up ] [ Designated as safety issue: No ]
  • Revised Peer Experiences Questionnaire (subscales for Relational and Reputational PV) [ Time Frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Anxiety Scale for Adolescents [ Time Frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up ] [ Designated as safety issue: No ]
  • Centers for Epidemiological Studies Depression Scale [ Time Frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up ] [ Designated as safety issue: No ]
  • Perceived Support Scale- Friends and Family [ Time Frame: Baseline, Change from baseline at 12 weeks, and at 6 month follow up ] [ Designated as safety issue: No ]
  • Cyber Peer Experiences Questionnaire [ Time Frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up ] [ Designated as safety issue: No ]
  • Revised Peer Experiences Questionnaire [ Time Frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up ] [ Designated as safety issue: No ]
  • Health Behaviors [ Time Frame: Screening, Baseline, Change from baseline at 12 weeks, and at 6 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UTalk Intervention
Active preventative intervention condition.
Behavioral: UTalk
Prevention intervention delivered in group format adapted from IPT-AST, for adolescents who experience peer victimization and who are at risk for developing social anxiety and depression.
No Intervention: Control
Education/Support Condition

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adolescents, ages 13-18 years (inclusive) and in grades 9, 10, or 11.
  • Participants must be sufficiently fluent in English (by their own self-report) to complete measures and intervention programs in this language.
  • Participants must report elevated levels of relational PV and/or reputational PV on screening measures (R-PEQ); i.e., adolescents must obtain a total score > or = to 6 on the relational and/or reputational subscales of the R-PEQ.
  • Participants must report symptoms of social anxiety and/or depression that exceed clinical cutoffs on the Social Anxiety Scale for Adolescents (SAS-A > or = to 50) or the Center for Epidemiologic Studies-Depression Scale (CES-D > or = to 16).

Exclusion Criteria:

  • Enrollment in special education services (e.g., for learning disabilities, mental retardation, pervasive developmental disorder).
  • Adolescents must not exceed clinical cutoffs (t score > 63) on the Aggression Subscale of the Youth Self Report (YSR).
  • Adolescents must not report elevated levels (score >6) on the overt peer victimization scale of the R-PEQ.
  • Adolescents must not currently meet diagnostic criteria for a social anxiety or depressive disorder as determined by the Anxiety Disorders Schedule for Children (ADIS-IV-C).
  • Adolescents must not currently meet criteria for PTSD, bipolar disorder, psychosis, or an eating, substance use, or conduct disorder on the ADIS-IV-C.
  • Adolescents must not endorse active suicidal items on the Columbia Suicide Severity Rating Scale (C-SSRS).
  • Adolescents must not be currently receiving treatment for social anxiety or depressive disorder.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02011438

Locations
United States, Florida
University of Miami
Coral Gables, Florida, United States, 33124
Sponsors and Collaborators
University of Miami
Columbia University
Investigators
Principal Investigator: Annette M La Greca, PhD University of Miami
  More Information

No publications provided

Responsible Party: Annette La Greca, PhD, Director, Clinical Training, University of Miami
ClinicalTrials.gov Identifier: NCT02011438     History of Changes
Other Study ID Numbers: 1 R34 MH095959-01A1
Study First Received: June 7, 2013
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Social Anxiety
Prevention
Peer Relations
Depression
Adolescent
High School
Interpersonal
Peer Victimization

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014