Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Anxiety Disorder
Other: Attentional Bias Modification Treatment (ABMT) - Active
Other: Attentional Bias Modification Treatment - Placebo
Behavioral: Cognitive Behavioral Group Therapy
Behavioral: Psychoeducational Control Intervention

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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 90
Study Start Date: August 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBGT+ABMT(active) 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.
Behavioral: Cognitive Behavioral Group Therapy
"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children
Experimental: CBGT+ABMT(placebo) 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
Experimental: PCI+ABMT(active) 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.
Behavioral: Psychoeducational Control Intervention
Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
Placebo Comparator: PCI+ABMT(placebo) 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: Psychoeducational Control Intervention
Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687764

Contacts
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

Locations
United States, Maryland
National Institute of Mental Health (NIMH) Active, not recruiting
Bethesda, Maryland, United States, 20892
Australia, Queensland
University of Queensland Active, not recruiting
Brisbane St Lucia, Queensland, Australia, 4072
Brazil
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA) Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Contact: Giovanni A Salum Junior, MD    +55 51 33598983    gsalumjr@gmail.com   
Contact: Rafaela Behs, MSc    +55 51 33598983    rafaelabehs@hotmail.com   
Principal Investigator: Gisele G Manfro, MD, PhD         
Principal Investigator: Silvia H Koller, PhD         
Sub-Investigator: Giovanni A Salum Junior, MD         
Sub-Investigator: Circe S Petersen, PhD         
Sub-Investigator: Rudineia Toazza         
Sub-Investigator: Rafaela B Jarros, MSc         
Sub-Investigator: Diogo Souza         
Israel
Tel-Aviv University Active, not recruiting
Tel-Aviv, Israel, 69987
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01687764     History of Changes
Other Study ID Numbers: HCPA11-0249
Study First Received: October 26, 2011
Last Updated: September 14, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Generalized Anxiety Disorder (GAD)
Separation Anxiety Disorder (SeAD)
Social Anxiety Disorder (SoAD)

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Disease
Mental Disorders
Phobic Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014