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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02443051
Other study ID # 13-180THO
Secondary ID
Status Completed
Phase N/A
First received May 2, 2015
Last updated May 12, 2017
Start date May 2013
Est. completion date December 2016

Study information

Verified date May 2017
Source Virginia Polytechnic Institute and State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 16 Years
Eligibility Inclusion Criteria:

- Diagnosis of Social Anxiety Disorder;

- English Speaking

Exclusion Criteria:

- Suicide Intent,

- Psychosis,

- Autism Spectrum Disorder

Study Design


Intervention

Behavioral:
Attention Bias Modification
Computer delivered modification in 80% of trials

Locations

Country Name City State
United States Child Study Center Blacksburg Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinician Severity Rating Immediately following treatment Post-treatment
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