Social AnxietyNCT02219243
Interpretive Biases in Children With Social Anxiety
A study testing Online Interpretation Training Condition 1 and Online Interpretation Training Condition 2 in people with Social Anxiety and Social Anxiety Disorder, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Social Anxiety, Social Anxiety Disorder
- What is being tested?
- Online Interpretation Training Condition 1 and Online Interpretation Training Condition 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UWM Anxiety Disorders Laboratory
Milwaukee, Wisconsin, 53211
About this study
Official title: Modification of Interpretive Biases in Children With Social Anxiety
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.
Read the detailed description
The current study aims to test the effectiveness of computer-based interpretation bias modification training as a therapeutic intervention for social anxiety disorder (SAD). Individuals who experience social anxiety often have difficulty in engaging in social situations, such as speaking in front of a group and maintaining a conversation. For youngsters, this may take the form of avoidance, including avoiding situations such as raising one's hand in class, eating in front of other people and participating in small group activities. Additionally, those with social anxiety are more likely to interpret ambiguous social scenarios in a threatening way than are control subjects (Bogels, Snieder, \& Kindt, 2003; Miers, Blote, Bogels, \& Westenberg, 2008; Vassilopoulos \& Banerjee, 2008; Vassilopoulos, 2006; Muris, Meckelbach, \& Damsma, 2000). Research has shown that interpretation biases are modifiable at a young age (Muris, Huijding, Mayer, \& Hameetman, 2008; Vassilopoulous, Bangerjee, Prantzalou, 2009; Muris, Huijding, Mayer, Remmerswaal, \& Vreden, 2009; Lothmann, Holmes, Chan, \& Lau, 2010).
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. Subjects do not need to come to the University of Wisconsin-Milwaukee to participate. Thirty children with social anxiety will be randomly assigned to one of the three conditions, and will be assessed at baseline, post-treatment, and 1-month follow-up. The waitlisted participants will also be invited to undergo the training program after the 1-month follow-up assessment is completed. This study is expected to generate important data that will guide the development of an accessible, cost-efficient, and effective cognitive intervention for individuals suffering from social anxiety.
- Conditions
- Social Anxiety, Social Anxiety Disorder
- Being tested
- Online Interpretation Training Condition 1, Online Interpretation Training Condition 2
- Keywords
- Social Anxiety Disorder, Cognitive Training, Interpretation Modification Program
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Interpretation Training Condition 1Behavioural
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
Online Interpretation Training Condition 2Behavioural
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Online Interpretation Training Condition 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This is a widely used assessment tool for symptoms of anxiety disorders. This measure will be administered at baseline, at 4 weeks, and at 1-month follow-up.
Measured: Baseline, 4 weeks, and 1-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Joo Lee, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219243
- Sponsor's protocol ID
- UWM14.141
- Status last verified
- Oct 2016
- First submitted
- 14 Aug 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Interpretive Biases in Children With Social Anxiety
- ClinicalTrials.gov ID
- NCT02219243
- Acronym / sponsor ID
- UWM14.141
- Conditions
- Social Anxiety, Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder, Cognitive Training, Interpretation Modification Program
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current study aims to test the effectiveness of computer-based interpretation bias modification training as a therapeutic intervention for social anxiety disorder (SAD). Individuals who experience social anxiety often have difficulty in engaging in social situations, such as speaking in front of a group and maintaining a conversation. For youngsters, this may take the form of avoidance, including avoiding situations such as raising one's hand in class, eating in front of other people and participating in small group activities. Additionally, those with social anxiety are more likely to interpret ambiguous social scenarios in a threatening way than are control subjects (Bogels, Snieder, \& Kindt, 2003; Miers, Blote, Bogels, \& Westenberg, 2008; Vassilopoulos \& Banerjee, 2008; Vassilopoulos, 2006; Muris, Meckelbach, \& Damsma, 2000). Research has shown that interpretation biases are modifiable at a young age (Muris, Huijding, Mayer, \& Hameetman, 2008; Vassilopoulous, Bangerjee, Prantzalou, 2009; Muris, Huijding, Mayer, Remmerswaal, \& Vreden, 2009; Lothmann, Holmes, Chan, \& Lau, 2010).
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. Subjects do not need to come to the University of Wisconsin-Milwaukee to participate. Thirty children with social anxiety will be randomly assigned to one of the three conditions, and will be assessed at baseline, post-treatment, and 1-month follow-up. The waitlisted participants will also be invited to undergo the training program after the 1-month follow-up assessment is completed. This study is expected to generate important data that will guide the development of an accessible, cost-efficient, and effective cognitive intervention for individuals suffering from social anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Online Interpretation Training Condition 1Online 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. |
| Placebo Interpretation Training | Experimental | Behavioral: Online Interpretation Training Condition 2Online 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Interpretation Training Condition 1The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios. | Behavioural | Active Interpretation Training |
| Online Interpretation Training Condition 2The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios. | Behavioural | Placebo Interpretation Training |
Primary outcome
Change on the Liebowitz Social Anxiety Scale for Children and Adolescents
Time frame: Baseline, 4-weeks, and 1-month follow-up
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.
1 secondary outcome
Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report
Time frame: Baseline, 4 weeks, and 1-month Follow-up
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Interpretation Training Condition 1 and Online Interpretation Training Condition 2 in people with Social Anxiety and Social Anxiety Disorder, run by University of Wisconsin, Milwaukee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the Liebowitz Social Anxiety Scale for Children and Adolescents (time frame: Baseline, 4-weeks, and 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.