Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD), Social Anxiety Disorder (SoAD)
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.
Interventions
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.
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.
BEHAVIORALCognitive Behavioral Group Therapy
FRIENDS for Life Australian protocol for the treatment of anxiety disorders in children
BEHAVIORALPsychoeducational Control Intervention
Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anxiety Rating Scale (PARS) / continuous | Endpoint (week 10) and 6-month follow-up | 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 | Endpoint (week-10) and 6-month follow-up | Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV) | Endpoint (week-10) and 6-month follow-up | Score change in SNAP-IV from baseline to week-10 and 6-month follow-up |
| Spence Children's Anxiety Scale (SCAS) | Endpoint (week-10) and 6-month follow-up | Score change in SCAS from baseline to week-10 and to 6-month follow-up |
| Screen for Children and Anxiety Related Emotional Disorders (SCARED) | Endpoint (week-10) and 6-months follow-up | Score change in SCARED child and parent versions from baseline to week 10 and 6-months follow-up |
| Biological measures | Endpoint (week-10) and 6-month follow-up | Change in biological measures from baseline to week-10 and to 6-month follow-up |
| Neuropsychological measures | Endpoint (week-10) and 6-month follow-up | Change in neuropsychological measures from baseline to week-10 and 6-month follow-up |
| Childhood Depression Inventory (CDI) | Endpoint (week-10) and 6-month follow-up | Score change in CDI from baseline to week-10 and to 6-month follow-up |
Countries
Australia, Brazil, Israel, United States
Contacts
Primary ContactGisele G Manfro, MD, PhD
Backup ContactGiovanni A Salum Junior, MD
Outcome results
None listed