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
This study is currently recruiting participants.
Verified September 2012 by Hospital de Clinicas de Porto Alegre
Sponsor:
Hospital de Clinicas de Porto Alegre
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
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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
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 Mental Disorders Phobic Disorders Mental Disorders Diagnosed in Childhood |
ClinicalTrials.gov processed this record on May 19, 2013