Active or Placebo ABMT with CBGT or PCI for Childhood Anxiety Disorders
This study aims to evaluate the effectiveness of Active or Placebo ABMT with CBGT or PCI in reducing anxiety in children, measured by changes in the Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up, and the percentage of subjects showing improvement in the Clinical Global Impression - Improvement Scale (CGI-I) in week 10 and in 6-month follow-up.
Attentional Bias Modification Treatment (ABMT) - Active
+ Cognitive Behavioral Group Therapy
+ Attentional Bias Modification Treatment - Placebo
Anxiety Disorders+4
+ Mental Disorders
+ Phobic Disorders
Treatment Study
Summary
Study start date: August 1, 2011
Actual date on which the first participant was enrolled.This study focuses on helping children who have anxiety disorders. It's trying to find out if a treatment called Attentional Bias Modification Treatment (ABMT) works better when combined with either Cognitive Behavioral Group Therapy (CBGT) or a Psychoeducational Control Intervention (PCI). The goal is to see if these combinations can improve the current ways of treating anxiety in children, making them more effective and beneficial for young patients. During this study, participants will receive either the active ABMT or a placebo version, along with one of the other two interventions (CBGT or PCI). The study will measure changes in anxiety levels using the Pediatric Anxiety Rating Scale (PARS) from the start of the study up to week 10 and then again at a 6-month follow-up. It will also assess the overall improvement in each child's condition using the Clinical Global Impression - Improvement Scale (CGI-I) at the same time points.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 7 to 11 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, BrazilOpen Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA) in Google MapsNational Institute of Mental Health (NIMH)
Bethesda, United StatesUniversity of Queensland
Brisbane Saint Lucia, AustraliaTel-Aviv University
Tel Aviv, Israel