Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children

Study Overview
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Brief Summary
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The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for anxiety disorders in children.

Official Title
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Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children: a Randomized Clinical Trial

Conditions
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Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Anxiety Disorder

Intervention / Treatment
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* Other: Attentional Bias Modification Treatment (ABMT) - Active
* Other: Attentional Bias Modification Treatment - Placebo
* Behavioral: Cognitive Behavioral Group Therapy
* Behavioral: Psychoeducational Control Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview Exclusion Criteria: Other psychiatric disorder that causes more impairment and suffering than GAD, SeAD or SoAD in the clinical evaluation Current or previous treatment (behavioral or pharmacological) for a psychaitric disorder in childhood IQ < 70 (Raven)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBGT+ABMT(active)<br> | Other: Attentional Bias Modification Treatment (ABMT) - Active<br>* The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.<br>Behavioral: Cognitive Behavioral Group Therapy<br>* FRIENDS for Life Australian protocol for the treatment of anxiety disorders in children<br>|
| Experimental: CBGT+ABMT(placebo)<br> | Other: Attentional Bias Modification Treatment - Placebo<br>* The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.<br>Behavioral: Cognitive Behavioral Group Therapy<br>* FRIENDS for Life Australian protocol for the treatment of anxiety disorders in children<br>|
| Experimental: PCI+ABMT(active)<br> | Other: Attentional Bias Modification Treatment (ABMT) - Active<br>* The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.<br>Behavioral: Psychoeducational Control Intervention<br>* Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities<br>|
| Placebo Comparator: PCI+ABMT(placebo)<br> | Other: Attentional Bias Modification Treatment - Placebo<br>* The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.<br>Behavioral: Psychoeducational Control Intervention<br>* Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Anxiety Rating Scale (PARS) / continuous | Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up | Endpoint (week 10) and 6-month follow-up | 
| Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous | Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up | Endpoint (week-10) and 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screen for Children and Anxiety Related Emotional Disorders (SCARED) | Score change in SCARED child and parent versions from baseline to week 10 and 6-months follow-up | Endpoint (week-10) and 6-months follow-up | 
| Childhood Depression Inventory (CDI) | Score change in CDI from baseline to week-10 and to 6-month follow-up | Endpoint (week-10) and 6-month follow-up | 
| Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV) | Score change in SNAP-IV from baseline to week-10 and 6-month follow-up | Endpoint (week-10) and 6-month follow-up | 
| Spence Children's Anxiety Scale (SCAS) | Score change in SCAS from baseline to week-10 and to 6-month follow-up | Endpoint (week-10) and 6-month follow-up | 
| Neuropsychological measures | Change in neuropsychological measures from baseline to week-10 and 6-month follow-up | Endpoint (week-10) and 6-month follow-up | 
| Biological measures | Change in biological measures from baseline to week-10 and to 6-month follow-up | Endpoint (week-10) and 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD), Social Anxiety Disorder (SoAD)