Treatment of Social Anxiety in Youth

NCT ID: NCT02443051

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Attention Bias Modification

Training in bias modification for 80% of experimental trials

Group Type: EXPERIMENTAL

Attention Bias Modification

Intervention Type: BEHAVIORAL

Computer delivered modification in 80% of trials

Control

Bias modification for 50% of trials

Group Type: ACTIVE_COMPARATOR

Attention Bias Modification

Intervention Type: BEHAVIORAL

Computer delivered modification in 80% of trials

Interventions

Attention Bias Modification

Computer delivered modification in 80% of trials

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Social Anxiety Disorder;
• English Speaking

Exclusion Criteria

• Suicide Intent,
• Psychosis,
• Autism Spectrum Disorder

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Thomas H. Ollendick

Professor - Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas H. Ollendick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Child Study Center

Blacksburg, Virginia, United States

Countries

United States

Other Identifiers

13-180THO

Identifier Type: -

Identifier Source: org_study_id