Clinical trial NCT01687764: 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: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Anxiety Disorder
Keywords: Generalized Anxiety Disorder (GAD)
Separation Anxiety Disorder (SeAD)
Social Anxiety Disorder (SoAD)
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Pediatric Anxiety Rating Scale (PARS) / continuous
timeFrame: Endpoint (week 10) and 6-month follow-up
measure: Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous
timeFrame: Endpoint (week-10) and 6-month follow-up
Secondary outcomes:
measure: Screen for Children and Anxiety Related Emotional Disorders (SCARED)
timeFrame: Endpoint (week-10) and 6-months follow-up
measure: Childhood Depression Inventory (CDI)
timeFrame: Endpoint (week-10) and 6-month follow-up
measure: Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)
timeFrame: Endpoint (week-10) and 6-month follow-up
measure: Spence Children's Anxiety Scale (SCAS)
timeFrame: Endpoint (week-10) and 6-month follow-up
measure: Neuropsychological measures
timeFrame: Endpoint (week-10) and 6-month follow-up
measure: Biological measures
timeFrame: Endpoint (week-10) and 6-month follow-up
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Mental Health (NIMH)
state: Maryland
city: Brisbane St Lucia
country: Australia
facility: University of Queensland
state: Queensland
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
state: Rio Grande do Sul
city: Tel-Aviv
country: Israel
facility: Tel-Aviv University
Study officials:
affiliation: Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre
name: Gisele G Manfro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul / University of Psychology
name: Silvia H Koller, PhD
role: PRINCIPAL_INVESTIGATOR
References: