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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBGT+ABMT(active) | Experimental |
| |
| CBGT+ABMT(placebo) | Experimental |
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| PCI+ABMT(active) | Experimental |
| |
| PCI+ABMT(placebo) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attentional Bias Modification Treatment (ABMT) - Active | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Endpoint (week 10) and 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 | Endpoint (week-10) and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Endpoint (week-10) and 6-months follow-up |
| Childhood Depression Inventory (CDI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gisele G Manfro, MD, PhD | Contact | +55 51 3359 8983 | gmanfro@portoweb.com.br | |
| Giovanni A Salum Junior, MD | Contact | +55 51 3359 8983 | gsalumjr@gmail.com.br |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Mental Health (NIMH) | Active, not recruiting | Bethesda | Maryland | 20892 | United States | |
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| Attentional Bias Modification Treatment - Placebo | Other | 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. |
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| Cognitive Behavioral Group Therapy | Behavioral | "FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children |
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| Psychoeducational Control Intervention | Behavioral | Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities |
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Score change in CDI from baseline to week-10 and to 6-month follow-up
| Endpoint (week-10) and 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 | Endpoint (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 | Endpoint (week-10) and 6-month follow-up |
| Neuropsychological measures | Change in neuropsychological measures from baseline to week-10 and 6-month follow-up | Endpoint (week-10) and 6-month follow-up |
| Biological measures | Change in biological measures from baseline to week-10 and to 6-month follow-up | Endpoint (week-10) and 6-month follow-up |
| University of Queensland |
| Active, not recruiting |
| Brisbane Saint Lucia |
| Queensland |
| 4072 |
| Australia |
| Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA) | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
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| Tel-Aviv University | Active, not recruiting | Tel Aviv | 69987 | Israel |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001010 | Anxiety, Separation |
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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