NCT02219243

Brief Summary

A substantial number of children with social anxiety fail to gain benefit from contemporary cognitive-behavior therapy (CBT) approaches. More novel treatment approaches for treatment of social anxiety are needed. The current study attempts to modify an interpretation style that is characteristic of children who also display high anxiety in social situations. Participants between the ages of 8-12 years old, with social anxiety, will be randomly assigned to one of three treatment conditions: two conditions are designed to manipulate the interpretation bias or a wait-list control condition. All study procedures will be conducted online. This study will help develop an effective cognitive intervention program for social anxiety in children.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

August 14, 2014

Last Update Submit

October 24, 2016

Conditions

Keywords

Social Anxiety DisorderCognitive TrainingInterpretation Modification Program

Outcome Measures

Primary Outcomes (1)

  • Change on the Liebowitz Social Anxiety Scale for Children and Adolescents

    A clinician-rated measure for assessing the severity of social anxiety and the impairment caused by it. This measure will be administered at baseline, at 4 weeks, and at 1-month follow-up.

    Baseline, 4-weeks, and 1-month follow-up

Secondary Outcomes (1)

  • Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report

    Baseline, 4 weeks, and 1-month Follow-up

Study Arms (3)

Waitlist Control

NO INTERVENTION

This is a 1-month waitlist control to be compared with the active online interpretation training interventions. This is a no intervention control group

Active Interpretation Training

EXPERIMENTAL

Online Interpretation Training Condition 2 provides three sessions of a computerized training. Each session will last approximately 20-30 minutes, and participants will undergo 1 session each week.

Behavioral: Online Interpretation Training Condition 1

Placebo Interpretation Training

EXPERIMENTAL

Online Interpretation Training Condition 1 provides three sessions of a computerized training. Each session will last approximately 20-30 minutes, and participants will undergo 1 session each week.

Behavioral: Online Interpretation Training Condition 2

Interventions

The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.

Active Interpretation Training

The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.

Placebo Interpretation Training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between ages 8-12
  • Diagnosis of social anxiety disorder
  • Overall IQ score of 80 or greater
  • Speak English fluently as the primary language
  • Working internet connection with access to Skype or Facetime video conferencing software

You may not qualify if:

  • Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder or Conduct Disorder
  • Pervasive developmental disorder or autism-spectrum disorder
  • Past or active psychosis, bipolar disorder, or schizophrenia
  • Current evidence-based cognitive-behavioral treatment for social anxiety problems
  • Past cognitive behavioral treatment for social anxiety problems that lasted at least 3 sessions
  • Significant suicidal ideation and/or attempts within the past 3 months
  • Any recent (within the past 4 weeks) or planned changes in medication
  • Reading disorder or impairments in reading ability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UWM Anxiety Disorders Laboratory

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations