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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
HCPA11-0249
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalized Anxiety Disorder 0 0
Separation Anxiety Disorder 0 0
Social Anxiety Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Endpoint (week 10) and 6-month follow-up
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Endpoint (week-10) and 6-month follow-up
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Endpoint (week-10) and 6-months follow-up
Secondary outcome [2] 0 0
Childhood Depression Inventory (CDI) - Score change in CDI from baseline to week-10 and to 6-month follow-up
Timepoint [2] 0 0
Endpoint (week-10) and 6-month follow-up
Secondary outcome [3] 0 0
Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV) - Score change in SNAP-IV from baseline to week-10 and 6-month follow-up
Timepoint [3] 0 0
Endpoint (week-10) and 6-month follow-up
Secondary outcome [4] 0 0
Spence Children's Anxiety Scale (SCAS) - Score change in SCAS from baseline to week-10 and to 6-month follow-up
Timepoint [4] 0 0
Endpoint (week-10) and 6-month follow-up
Secondary outcome [5] 0 0
Neuropsychological measures - Change in neuropsychological measures from baseline to week-10 and 6-month follow-up
Timepoint [5] 0 0
Endpoint (week-10) and 6-month follow-up
Secondary outcome [6] 0 0
Biological measures - Change in biological measures from baseline to week-10 and to 6-month follow-up
Timepoint [6] 0 0
Endpoint (week-10) and 6-month follow-up

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
Minimum age
7 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Queensland - Brisbane St Lucia
Recruitment postcode(s) [1] 0 0
4072 - Brisbane St Lucia
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio Grande do Sul
Country [3] 0 0
Israel
State/province [3] 0 0
Tel-Aviv

Funding & Sponsors
Primary sponsor type
Other
Name
Hospital de Clinicas de Porto Alegre
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01687764
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gisele G Manfro, MD, PhD
Address 0 0
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gisele G Manfro, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+55 51 3359 8983
Fax 0 0
Email 0 0
gmanfro@portoweb.com.br
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01687764