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

NCT01687764 | Unknown

• 1 other identifier: HCPA11-0249
• Study Type: interventional
• Target: 90
• Locations: 4 countries
• Sites: 4

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.

Conditions

Generalized Anxiety Disorder; Separation Anxiety Disorder; Social Anxiety Disorder

Keywords

Generalized Anxiety Disorder (GAD); Separation Anxiety Disorder (SeAD); Social Anxiety Disorder (SoAD)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Endpoint (week-10) and 6-month follow-up

Secondary Outcomes (6)

• Screen for Children and Anxiety Related Emotional Disorders (SCARED)

  Endpoint (week-10) and 6-months follow-up

• Childhood Depression Inventory (CDI)

  Endpoint (week-10) and 6-month follow-up

• Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)

  Endpoint (week-10) and 6-month follow-up

• Spence Children's Anxiety Scale (SCAS)

  Endpoint (week-10) and 6-month follow-up

• Neuropsychological measures

  Endpoint (week-10) and 6-month follow-up

Study Arms (4)

CBGT+ABMT(active)

EXPERIMENTAL

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

CBGT+ABMT(placebo)

EXPERIMENTAL

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

PCI+ABMT(active)

EXPERIMENTAL

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

PCI+ABMT(placebo)

PLACEBO COMPARATOR

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

Interventions

Attentional Bias Modification Treatment (ABMT) - Active OTHER

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.

CBGT+ABMT(active); PCI+ABMT(active)

Attentional Bias Modification Treatment - Placebo OTHER

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.

CBGT+ABMT(placebo); PCI+ABMT(placebo)

Cognitive Behavioral Group Therapy BEHAVIORAL

"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children

CBGT+ABMT(active); CBGT+ABMT(placebo)

Psychoeducational Control Intervention BEHAVIORAL

Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

PCI+ABMT(active); PCI+ABMT(placebo)

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (4)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

ACTIVE NOT RECRUITING

University of Queensland

Brisbane Saint 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

Tel-Aviv University

Tel Aviv, 69987, Israel

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety, Separation; Phobia, Social

Interventions

Exercise

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Neurodevelopmental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gisele G Manfro, MD, PhD

  Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Silvia H Koller, PhD

  Federal University of Rio Grande do Sul / University of Psychology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gisele G Manfro, MD, PhD

CONTACT

+55 51 3359 8983; gmanfro@portoweb.com.br

Giovanni A Salum Junior, MD

CONTACT

+55 51 3359 8983; gsalumjr@gmail.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: September 19, 2012
• Study Start: August 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

US (1); BR (1); IL (1); AU (1)