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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01687764
Registration number
NCT01687764
Ethics application status
Date submitted
26/10/2011
Date registered
19/09/2012
Date last updated
19/09/2012
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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HCPA11-0249
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Generalized Anxiety Disorder
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Separation Anxiety Disorder
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Social Anxiety Disorder
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Condition category
Condition code
Mental Health
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Attentional Bias Modification Treatment (ABMT) - Active
Other interventions - Attentional Bias Modification Treatment - Placebo
Behaviour - Cognitive Behavioral Group Therapy
Behaviour - Psychoeducational Control Intervention
Experimental: CBGT+ABMT(active) -
Experimental: CBGT+ABMT(placebo) -
Experimental: PCI+ABMT(active) -
Placebo Comparator: PCI+ABMT(placebo) -
Other interventions: 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.
Other interventions: 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.
Behaviour: Cognitive Behavioral Group Therapy
"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children
Behaviour: Psychoeducational Control Intervention
Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pediatric Anxiety Rating Scale (PARS) / continuous
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Assessment method [1]
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Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up
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Timepoint [1]
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Endpoint (week 10) and 6-month follow-up
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Primary outcome [2]
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Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous
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Assessment method [2]
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Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up
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Timepoint [2]
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Endpoint (week-10) and 6-month follow-up
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Secondary outcome [1]
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Screen for Children and Anxiety Related Emotional Disorders (SCARED)
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Assessment method [1]
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Score change in SCARED child and parent versions from baseline to week 10 and 6-months follow-up
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Timepoint [1]
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Endpoint (week-10) and 6-months follow-up
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Secondary outcome [2]
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Childhood Depression Inventory (CDI)
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Assessment method [2]
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Score change in CDI from baseline to week-10 and to 6-month follow-up
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Timepoint [2]
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Endpoint (week-10) and 6-month follow-up
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Secondary outcome [3]
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Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)
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Assessment method [3]
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Score change in SNAP-IV from baseline to week-10 and 6-month follow-up
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Timepoint [3]
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Endpoint (week-10) and 6-month follow-up
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Secondary outcome [4]
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Spence Children's Anxiety Scale (SCAS)
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Assessment method [4]
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Score change in SCAS from baseline to week-10 and to 6-month follow-up
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Timepoint [4]
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Endpoint (week-10) and 6-month follow-up
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Secondary outcome [5]
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Neuropsychological measures
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Assessment method [5]
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Change in neuropsychological measures from baseline to week-10 and 6-month follow-up
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Timepoint [5]
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Endpoint (week-10) and 6-month follow-up
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Secondary outcome [6]
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Biological measures
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Assessment method [6]
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Change in biological measures from baseline to week-10 and to 6-month follow-up
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Timepoint [6]
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Endpoint (week-10) and 6-month follow-up
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Eligibility
Key inclusion criteria
- Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder
(SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview
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Minimum age
7
Years
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Maximum age
11
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2013
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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University of Queensland - Brisbane St Lucia
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Recruitment postcode(s) [1]
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4072 - Brisbane St Lucia
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Country [2]
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Brazil
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State/province [2]
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Rio Grande do Sul
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Country [3]
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Israel
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State/province [3]
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Tel-Aviv
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Funding & Sponsors
Primary sponsor type
Other
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Name
Hospital de Clinicas de Porto Alegre
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01687764
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gisele G Manfro, MD, PhD
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Address
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Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gisele G Manfro, MD, PhD
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Address
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Country
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Phone
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+55 51 3359 8983
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01687764
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