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Generalized Anxiety Disorder | 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

Generalized Anxiety Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Generalized Anxiety Disorder

Separation Anxiety Disorder

Social Anxiety Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Attentional Bias Modification Treatment (ABMT) - ActiveThe 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.

Other:Attentional Bias Modification Treatment - PlaceboThe 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.

Behavioral:Cognitive Behavioral Group Therapy"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children

Behavioral:Psychoeducational Control InterventionPsychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CBGT+ABMT(active)

CBGT+ABMT(placebo)

PCI+ABMT(active)

PCI+ABMT(placebo)

Study Status

Unknown status

Start Date: August 2011

Completed Date: January 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Pediatric Anxiety Rating Scale (PARS) / continuous

Secondary Outcome: Screen for Children and Anxiety Related Emotional Disorders (SCARED)

Study sponsors, principal investigator, and references

Principal Investigator: Gisele G Manfro, MD, PhD

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01687764

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