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Treatment of Social Anxiety in Youth

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of Social Anxiety Disorder;
  • English Speaking

Exclusion Criteria:

  • Suicide Intent,
  • Psychosis,
  • Autism Spectrum Disorder

Sites / Locations

  • Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Attention Bias Modification

Control

Arm Description

Training in bias modification for 80% of experimental trials

Bias modification for 50% of trials

Outcomes

Primary Outcome Measures

Clinician Severity Rating
Immediately following treatment

Secondary Outcome Measures

Full Information

First Posted
May 2, 2015
Last Updated
May 12, 2017
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT02443051
Brief Title
Treatment of Social Anxiety in Youth
Official Title
Attention Training for Adolescents With Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research is designed to determine the effectiveness of attention bias modification for socially anxious children and adolescents. Over the course of 3 years, 50 youth will be enrolled in the trial.
Detailed Description
The primary objective of this study is to develop an Attention Training (AT) protocol for adolescents with social anxiety disorder (SAD). Attentional biases to threat have been shown to be associated with the development and maintenance of anxiety disorders, in both adults and youth. Given these relations, AT paradigms have been developed to modify these attentional biases. Such paradigms have been shown to be promising in the treatment of adult anxiety. However, to date, only two small studies have examined the use of AT with children, and no ATT protocol has been developed specifically for use with children or adolescents. This is important, given the complications and possible ineffectiveness of applying adult-designed therapies to youth. Given this gap in the literature, the primary aims of the current study are intended to develop a treatment program to address attentional biases and anxiety in adolescents with SAD, to collect preliminary data regarding the program's short-term efficacy and feasibility, and to explore attention biases as a mediator and moderator of initial treatment outcomes. It is hypothesized that the AT protocol developed in the current project, compared to a placebo control comparator condition, will result in reductions in social anxiety among a sample of adolescents with SAD. Further, the AT protocol is expected to reduce attentional biases to threat among those adolescents who possess such biases prior to treatment (not all adolescents are expected to show this bias yet AT has been shown to be potentially effective with these youth; the presence/absence of attention bias will be explored as a moderator of change). The proposed study will be a pivotal step towards assessing the feasibility of an adolescent-focused AT procedure for the treatment of SAD. Results will contribute to an emerging body of research exploring the ameliorating effects of experimental paradigms that target information processing biases in anxious youth. Given emerging evidence regarding the use of AT in adult populations, findings from this study may have implications for improving the current prevention and treatment options available for anxious adolescents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Bias Modification
Arm Type
Experimental
Arm Description
Training in bias modification for 80% of experimental trials
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Bias modification for 50% of trials
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification
Intervention Description
Computer delivered modification in 80% of trials
Primary Outcome Measure Information:
Title
Clinician Severity Rating
Description
Immediately following treatment
Time Frame
Post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of Social Anxiety Disorder; English Speaking Exclusion Criteria: Suicide Intent, Psychosis, Autism Spectrum Disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H. Ollendick, Ph.D.
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Study Center
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Social Anxiety in Youth

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