Suspended

Active or Placebo ABMT with CBGT or PCI for Childhood Anxiety Disorders

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Study Aim

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.

What is being tested

Attentional Bias Modification Treatment (ABMT) - Active

+ Cognitive Behavioral Group Therapy

+ Attentional Bias Modification Treatment - Placebo

OtherBehavioral
Who is being recruted

Anxiety Disorders+4

+ Mental Disorders

+ Phobic Disorders

From 7 to 11 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2011
See protocol details

Summary

Principal SponsorHospital de Clinicas de Porto Alegre
Study ContactGisele G Manfro, MD, PhDMore contacts
Last updated: September 19, 2012
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorHospital de Clinicas de Porto Alegre
Study ContactGisele G Manfro, MD, PhDMore contacts
Last updated: September 19, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Anxiety DisordersMental DisordersPhobic DisordersNeurodevelopmental DisordersPhobia, SocialGeneralized Anxiety DisorderAnxiety, Separation

Criteria

1 inclusion criteria required to participate
Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview

3 exclusion criteria prevent from participating
Current or previous treatment (behavioral or pharmacological) for a psychaitric disorder in childhood

IQ < 70 (Raven)

Other psychiatric disorder that causes more impairment and suffering than GAD, SeAD or SoAD in the clinical evaluation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Placebo

Study 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

Recruiting

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 Maps
Suspended

National Institute of Mental Health (NIMH)

Bethesda, United States
Suspended

University of Queensland

Brisbane Saint Lucia, Australia
Suspended

Tel-Aviv University

Tel Aviv, Israel
Suspended4 Study Centers