- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443051
Treatment of Social Anxiety in Youth
May 12, 2017 updated by: Thomas H. Ollendick, Virginia Polytechnic Institute and State University
Attention Training for Adolescents With Social Anxiety Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24060
- Child Study Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of Social Anxiety Disorder;
- English Speaking
Exclusion Criteria:
- Suicide Intent,
- Psychosis,
- Autism Spectrum Disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Attention Bias Modification
Training in bias modification for 80% of experimental trials
|
Computer delivered modification in 80% of trials
|
Active Comparator: Control
Bias modification for 50% of trials
|
Computer delivered modification in 80% of trials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician Severity Rating
Time Frame: Post-treatment
|
Immediately following treatment
|
Post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas H. Ollendick, Ph.D., Virginia Polytechnic Institute and State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
May 2, 2015
First Submitted That Met QC Criteria
May 8, 2015
First Posted (Estimate)
May 13, 2015
Study Record Updates
Last Update Posted (Actual)
May 16, 2017
Last Update Submitted That Met QC Criteria
May 12, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-180THO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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