ClinicalTrials.gg
Status unknownNCT01687764Updated Sep 19, 2012

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

An interventional study of Attentional Bias Modification Treatment (ABMT) - Active and Attentional Bias Modification Treatment - Placebo in Generalized Anxiety Disorder, Separation Anxiety Disorder and Social Anxiety Disorder, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 4 sites in 4 countries. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2012-09-19.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 265 studies in Generalized Anxiety Disorder with a site in United States — 38 open to participants now, 53 under way, 9 of them phase 3. Generalized Anxiety Disorder · United States.

Planned enrollment
115th of 234
90 · median 90
Started
2011
with 5 others
No phase
122 of 265
18 open now
Registered
100th of 265
by date

Among the 265 studies in Generalized Anxiety Disorder with a site in United States, this one is the 115th largest by planned enrollment of the 234 interventional ones that give a count, is one of 6 that started in 2011, is one of 122 with no phase, and was the 100th registered.

Generalized Anxiety Disorder

517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.

Browse Generalized Anxiety Disorder studies →

Open to participants now

38 of the 265 studies in Generalized Anxiety Disorder with a site in United States are open now. Recruiting first, the newest first:

33 more — sign in →

All 38 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 86 Generalized Anxiety Disorder studies recruiting now, 32 (37%) set no upper age limit and 52 (60%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.

This study: 7 Years to 11 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Generalized Anxiety Disorder
  • Separation Anxiety Disorder
  • Social Anxiety Disorder

Keywords

  • Generalized Anxiety Disorder (GAD)
  • Separation Anxiety Disorder (SeAD)
  • Social Anxiety Disorder (SoAD)
04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    CBGT+ABMT(active)

    Other: Attentional Bias Modification Treatment (ABMT) - Active · Behavioral: Cognitive Behavioral Group Therapy

  • Experimental
    CBGT+ABMT(placebo)

    Other: Attentional Bias Modification Treatment - Placebo · Behavioral: Cognitive Behavioral Group Therapy

  • Experimental
    PCI+ABMT(active)

    Other: Attentional Bias Modification Treatment (ABMT) - Active · Behavioral: Psychoeducational Control Intervention

  • Placebo comparator
    PCI+ABMT(placebo)

    Other: Attentional Bias Modification Treatment - Placebo · Behavioral: Psychoeducational Control Intervention

Interventions

  • OtherAttentional 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.

  • OtherAttentional 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.

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Endpoint (week 10) and 6-month follow-up

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

07

Study locations

1 of 4 sites recruiting
  • National Institute of Mental Health (NIMH)
    Bethesda, Maryland 20892, United States
    Active, not recruiting
  • University of Queensland
    Brisbane St Lucia, Queensland 4072, Australia
    Active, not recruiting
  • Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
    Porto Alegre, Rio Grande do Sul 90035-003, Brazil
    Recruiting
    • Giovanni A Salum Junior, MD · Contactgsalumjr@gmail.com · +55 51 33598983
    • Rafaela Behs, MSc · Contactrafaelabehs@hotmail.com · +55 51 33598983
    • Gisele G Manfro, MD, PhD · Principal investigator
    • Silvia H Koller, PhD · Principal investigator
    • Giovanni A Salum Junior, MD · Sub investigator
    • Circe S Petersen, PhD · Sub investigator
    • Rudineia Toazza · Sub investigator
    • Rafaela B Jarros, MSc · Sub investigator
    • Diogo Souza · Sub investigator
  • Tel-Aviv University
    Tel-Aviv, 69987, Israel
    Active, not recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2011, a primary completion of Jan 2013 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2011
First posted
Sep 19, 2012
Start
Aug 2011
Primary completionEst.
Jan 2013
CompletionEst.
Jan 2013
Last update
Sep 19, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01687764
Responsible party
Sponsor
First posted
Sep 19, 2012
Start date
Aug 2011
Primary completion
Jan 2013 (estimated)
Completion
Jan 2013 (estimated)
Last update
Sep 19, 2012

Study contacts

Gisele G Manfro, MD, PhD
Contact
gmanfro@portoweb.com.br
+55 51 3359 8983
Giovanni A Salum Junior, MD
Contact
gsalumjr@gmail.com.br
+55 51 3359 8983
Gisele G Manfro, MD, PhD
principal investigator · Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre
Silvia H Koller, PhD
principal investigator · Federal University of Rio Grande do Sul / University of Psychology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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