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

Hospital de Clinicas de Porto Alegre4 sites in 4 countries90 target enrollmentAugust 2011

ConditionsGeneralized Anxiety Disorder Separation Anxiety Disorder Social Anxiety Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Generalized Anxiety Disorder
Sponsor: Hospital de Clinicas de Porto Alegre
Enrollment: 90
Locations: 4
Primary Endpoint: Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

January 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Hospital de Clinicas de Porto Alegre

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous

Time Frame: Endpoint (week-10) and 6-month follow-up

Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up

Pediatric Anxiety Rating Scale (PARS) / continuous

Time Frame: Endpoint (week 10) and 6-month follow-up

Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up

Secondary Outcomes

Screen for Children and Anxiety Related Emotional Disorders (SCARED)(Endpoint (week-10) and 6-months follow-up)
Childhood Depression Inventory (CDI)(Endpoint (week-10) and 6-month follow-up)
Spence Children's Anxiety Scale (SCAS)(Endpoint (week-10) and 6-month follow-up)
Biological measures(Endpoint (week-10) and 6-month follow-up)
Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)(Endpoint (week-10) and 6-month follow-up)
Neuropsychological measures(Endpoint (week-10) and 6-month follow-up)