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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gisele G Manfro, MD, PhD; Phone Number: +55 51 3359 8983; Email: gmanfro@portoweb.com.br
• Study Contact Backup: Name: Giovanni A Salum Junior, MD; Phone Number: +55 51 3359 8983; Email: gsalumjr@gmail.com.br

Study Locations

• Australia
  • Queensland
    • Brisbane St Lucia, Queensland, Australia, 4072
      • Active, not recruiting
      • University of Queensland
• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Recruiting
      • Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
      • Contact: Giovanni A Salum Junior, MD; Phone Number: +55 51 33598983; Email: gsalumjr@gmail.com
      • Contact: Rafaela Behs, MSc; Phone Number: +55 51 33598983; Email: rafaelabehs@hotmail.com
      • Principal Investigator: Gisele G Manfro, MD, PhD
      • Principal Investigator: Silvia H Koller, PhD
      • Sub-Investigator: Giovanni A Salum Junior, MD
      • Sub-Investigator: Circe S Petersen, PhD
      • Sub-Investigator: Rudineia Toazza
      • Sub-Investigator: Rafaela B Jarros, MSc
      • Sub-Investigator: Diogo Souza
• Israel
  • Tel-Aviv, Israel, 69987
    • Active, not recruiting
    • Tel-Aviv University
• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Active, not recruiting
      • National Institute of Mental Health (NIMH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CBGT+ABMT(active)	Other: Attentional Bias Modification Treatment (ABMT) - Active; 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.; Behavioral: Cognitive Behavioral Group Therapy; "FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children
EXPERIMENTAL: CBGT+ABMT(placebo)	Behavioral: Cognitive Behavioral Group Therapy; "FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children; Other: Attentional Bias Modification Treatment - Placebo; 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.
EXPERIMENTAL: PCI+ABMT(active)	Other: Attentional Bias Modification Treatment (ABMT) - Active; 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.; Behavioral: Psychoeducational Control Intervention; Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
PLACEBO_COMPARATOR: PCI+ABMT(placebo)	Other: Attentional Bias Modification Treatment - Placebo; 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.; Behavioral: Psychoeducational Control Intervention; Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Gisele G Manfro, MD, PhD, Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre; Principal Investigator: Silvia H Koller, PhD, Federal University of Rio Grande do Sul / University of Psychology

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ANTICIPATED): January 1, 2013
• Study Completion (ANTICIPATED): January 1, 2013

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: September 14, 2012
• First Posted (ESTIMATE): September 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 19, 2012
• Last Update Submitted That Met QC Criteria: September 14, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder (GAD); Separation Anxiety Disorder (SeAD); Social Anxiety Disorder (SoAD)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social; Anxiety, Separation
• Other Study ID Numbers: HCPA11-0249