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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01687764
First received: October 26, 2011
Last updated: September 14, 2012
Last verified: September 2012

October 26, 2011
September 14, 2012
August 2011
January 2013   (final data collection date for primary outcome measure)
  • Pediatric Anxiety Rating Scale (PARS) / continuous [ Time Frame: Endpoint (week 10) and 6-month follow-up ] [ Designated as safety issue: No ]
    Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up
  • Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous [ Time Frame: Endpoint (week-10) and 6-month follow-up ] [ Designated as safety issue: No ]
    Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up
Same as current
Complete list of historical versions of study NCT01687764 on ClinicalTrials.gov Archive Site
  • Screen for Children and Anxiety Related Emotional Disorders (SCARED) [ Time Frame: Endpoint (week-10) and 6-months follow-up ] [ Designated as safety issue: No ]
    Score change in SCARED child and parent versions from baseline to week 10 and 6-months follow-up
  • Childhood Depression Inventory (CDI) [ Time Frame: Endpoint (week-10) and 6-month follow-up ] [ Designated as safety issue: No ]
    Score change in CDI from baseline to week-10 and to 6-month follow-up
  • Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV) [ Time Frame: Endpoint (week-10) and 6-month follow-up ] [ Designated as safety issue: No ]
    Score change in SNAP-IV from baseline to week-10 and 6-month follow-up
  • Spence Children's Anxiety Scale (SCAS) [ Time Frame: Endpoint (week-10) and 6-month follow-up ] [ Designated as safety issue: No ]
    Score change in SCAS from baseline to week-10 and to 6-month follow-up
  • Neuropsychological measures [ Time Frame: Endpoint (week-10) and 6-month follow-up ] [ Designated as safety issue: No ]
    Change in neuropsychological measures from baseline to week-10 and 6-month follow-up
  • Biological measures [ Time Frame: Endpoint (week-10) and 6-month follow-up ] [ Designated as safety issue: No ]
    Change in biological measures from baseline to week-10 and to 6-month follow-up
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Generalized Anxiety Disorder
  • Separation Anxiety Disorder
  • Social Anxiety Disorder
  • 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.
  • 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: Cognitive Behavioral Group Therapy
    "FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children
  • Behavioral: Psychoeducational Control Intervention
    Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
  • Experimental: CBGT+ABMT(active)
    Interventions:
    • Other: Attentional Bias Modification Treatment (ABMT) - Active
    • Behavioral: Cognitive Behavioral Group Therapy
  • Experimental: CBGT+ABMT(placebo)
    Interventions:
    • Other: Attentional Bias Modification Treatment - Placebo
    • Behavioral: Cognitive Behavioral Group Therapy
  • Experimental: PCI+ABMT(active)
    Interventions:
    • Other: Attentional Bias Modification Treatment (ABMT) - Active
    • Behavioral: Psychoeducational Control Intervention
  • Placebo Comparator: PCI+ABMT(placebo)
    Interventions:
    • Other: Attentional Bias Modification Treatment - Placebo
    • Behavioral: Psychoeducational Control Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
January 2013
January 2013   (final data collection date for primary outcome measure)

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)
Both
7 Years to 11 Years
No
Contact: Gisele G Manfro, MD, PhD +55 51 3359 8983 gmanfro@portoweb.com.br
Contact: Giovanni A Salum Junior, MD +55 51 3359 8983 gsalumjr@gmail.com.br
United States,   Australia,   Brazil,   Israel
 
NCT01687764
HCPA11-0249
Not Provided
Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Not Provided
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
Hospital de Clinicas de Porto Alegre
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP