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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
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.
"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children
Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States
ACTIVE_NOT_RECRUITINGUniversity of Queensland
Brisbane Saint Lucia, Queensland, Australia
ACTIVE_NOT_RECRUITINGFederal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGTel-Aviv University
Tel Aviv, Israel
ACTIVE_NOT_RECRUITINGPediatric Anxiety Rating Scale (PARS) / continuous
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
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
Time frame: Endpoint (week-10) and 6-month follow-up
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
Time frame: Endpoint (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
Time frame: 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
Time frame: 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
Time frame: Endpoint (week-10) and 6-month follow-up
Neuropsychological measures
Change in neuropsychological measures from baseline to week-10 and 6-month follow-up
Time frame: 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
Time frame: Endpoint (week-10) and 6-month follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.