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

Not Applicable

• Conditions: Separation Anxiety Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder
• Interventions: Other: Attentional Bias Modification Treatment (ABMT) - Active; Other: Attentional Bias Modification Treatment - Placebo; Behavioral: Cognitive Behavioral Group Therapy; Behavioral: Psychoeducational Control Intervention

• Registration Number: NCT01687764
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-26
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-14
• Last Update Submitted: 2012-09-14
• Study First Posted: 2012-09-19
• Last Update Posted: 2012-09-19
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
CBGT+ABMT(placebo)	Cognitive Behavioral Group Therapy	-
CBGT+ABMT(active)	Attentional Bias Modification Treatment (ABMT) - Active	-
CBGT+ABMT(placebo)	Attentional Bias Modification Treatment - Placebo	-
PCI+ABMT(active)	Psychoeducational Control Intervention	-
CBGT+ABMT(active)	Cognitive Behavioral Group Therapy	-
PCI+ABMT(active)	Attentional Bias Modification Treatment (ABMT) - Active	-
PCI+ABMT(placebo)	Attentional Bias Modification Treatment - Placebo	-
PCI+ABMT(placebo)	Psychoeducational Control Intervention	-

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous	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	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 Outcome Measures

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

Trial Locations

Locations (4)

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA); 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

National Institute of Mental Health (NIMH); 🇺🇸 Bethesda, Maryland, United States

University of Queensland; 🇦🇺 Brisbane St Lucia, Queensland, Australia

Tel-Aviv University; 🇮🇱 Tel-Aviv, Israel