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 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01687764
• Other study ID #: HCPA11-0249
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2011
• Last updated: September 14, 2012
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2012
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Gisele G Manfro, MD, PhD
• Phone: +55 51 3359 8983
• Email: gmanfro[@]portoweb.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Generalized Anxiety Disorder
• Mental Disorders
• Phobic Disorders
• Separation Anxiety Disorder
• Social Anxiety Disorder

Intervention

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.
• 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
• Psychoeducational Control Intervention
Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

Locations

Country	Name	City	State
Australia	University of Queensland	Brisbane St Lucia	Queensland
Brazil	Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)	Porto Alegre	Rio Grande do Sul
Israel	Tel-Aviv University	Tel-Aviv
United States	National Institute of Mental Health (NIMH)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Neuropsychological measures	Change in neuropsychological measures from baseline to week-10 and 6-month follow-up	Endpoint (week-10) and 6-month follow-up	No
Secondary	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	No