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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

Primary Purpose

Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Anxiety Disorder

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Attentional Bias Modification Treatment (ABMT) - Active

Attentional Bias Modification Treatment - Placebo

Cognitive Behavioral Group Therapy

Psychoeducational Control Intervention

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD), Social Anxiety Disorder (SoAD)

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

National Institute of Mental Health (NIMH)
University of Queensland
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)Recruiting
Tel-Aviv University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

CBGT+ABMT(active)

CBGT+ABMT(placebo)

PCI+ABMT(active)

PCI+ABMT(placebo)

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Childhood Depression Inventory (CDI)

Score change in CDI from baseline to week-10 and to 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

Spence Children's Anxiety Scale (SCAS)

Score change in SCAS from baseline to week-10 and to 6-month follow-up

Neuropsychological measures

Change in neuropsychological measures from baseline to week-10 and 6-month follow-up

Biological measures

Change in biological measures from baseline to week-10 and to 6-month follow-up

Full Information

NCT ID

NCT01687764

First Posted

October 26, 2011

Last Updated

September 14, 2012

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT01687764

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2011 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Anxiety Disorder

Keywords

Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD), Social Anxiety Disorder (SoAD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CBGT+ABMT(active)

Arm Type

Experimental

Arm Title

CBGT+ABMT(placebo)

Arm Type

Experimental

Arm Title

PCI+ABMT(active)

Arm Type

Experimental

Arm Title

PCI+ABMT(placebo)

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Attentional Bias Modification Treatment (ABMT) - Active

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Attentional Bias Modification Treatment - Placebo

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Group Therapy

Intervention Description

"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children

Intervention Type

Behavioral

Intervention Name(s)

Psychoeducational Control Intervention

Intervention Description

Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

Primary Outcome Measure Information:

Title

Pediatric Anxiety Rating Scale (PARS) / continuous

Description

Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up

Time Frame

Endpoint (week 10) and 6-month follow-up

Title

Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous

Description

Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up

Time Frame

Endpoint (week-10) and 6-month follow-up

Secondary Outcome Measure Information:

Title

Screen for Children and Anxiety Related Emotional Disorders (SCARED)

Description

Score change in SCARED child and parent versions from baseline to week 10 and 6-months follow-up

Time Frame

Endpoint (week-10) and 6-months follow-up

Title

Childhood Depression Inventory (CDI)

Description

Score change in CDI from baseline to week-10 and to 6-month follow-up

Time Frame

Endpoint (week-10) and 6-month follow-up

Title

Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)

Description

Score change in SNAP-IV from baseline to week-10 and 6-month follow-up

Time Frame

Endpoint (week-10) and 6-month follow-up

Title

Spence Children's Anxiety Scale (SCAS)

Description

Score change in SCAS from baseline to week-10 and to 6-month follow-up

Time Frame

Endpoint (week-10) and 6-month follow-up

Title

Neuropsychological measures

Description

Change in neuropsychological measures from baseline to week-10 and 6-month follow-up

Time Frame

Endpoint (week-10) and 6-month follow-up

Title

Biological measures

Description

Change in biological measures from baseline to week-10 and to 6-month follow-up

Time Frame

Endpoint (week-10) and 6-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gisele G Manfro, MD, PhD

Phone

+55 51 3359 8983

gmanfro@portoweb.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Giovanni A Salum Junior, MD

Phone

+55 51 3359 8983

gsalumjr@gmail.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gisele G Manfro, MD, PhD

Organizational Affiliation

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Silvia H Koller, PhD

Organizational Affiliation

Federal University of Rio Grande do Sul / University of Psychology

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Mental Health (NIMH)

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

University of Queensland

City

Brisbane St Lucia

State/Province

Queensland

ZIP/Postal Code

4072

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

90035-003

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giovanni A Salum Junior, MD

Phone

+55 51 33598983

gsalumjr@gmail.com

First Name & Middle Initial & Last Name & Degree

Rafaela Behs, MSc

Phone

+55 51 33598983

rafaelabehs@hotmail.com

First Name & Middle Initial & Last Name & Degree

Gisele G Manfro, MD, PhD

First Name & Middle Initial & Last Name & Degree

Silvia H Koller, PhD

First Name & Middle Initial & Last Name & Degree

Giovanni A Salum Junior, MD

First Name & Middle Initial & Last Name & Degree

Circe S Petersen, PhD

First Name & Middle Initial & Last Name & Degree

Rudineia Toazza

First Name & Middle Initial & Last Name & Degree

Rafaela B Jarros, MSc

First Name & Middle Initial & Last Name & Degree

Diogo Souza

Facility Name

Tel-Aviv University

City

Tel-Aviv

ZIP/Postal Code

69987

Country

Israel

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

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