Attention Bias Modification Training for Child Anxiety CBT Nonresponders

NCT01819311 | Completed Results DMC

• 1 other identifier: MH097931
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This project will test Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose of this project is to determine whether ABMT leads to reductions in anxiety and related impairment, relative to a placebo task condition.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• Clinician Rating on the Pediatric Anxiety Rating Scale

  The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.

  post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

• Clinician Rating on the Pediatric Anxiety Rating Scale

  The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.

  8-week follow-up

Secondary Outcomes (4)

• Screen for Child Anxiety Related Emotional Disorders - Parent Version

  post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

• Screen for Child Anxiety Related Emotional Disorders - Child Version

  post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)

• Screen for Child Anxiety Related Emotional Disorders - Parent Version

  8-week follow-up

• Screen for Child Anxiety Related Emotional Disorders - Child Version

  8-week follow-up

Study Arms (2)

Attention Bias Modification

EXPERIMENTAL

Attention Bias Modification is a computer-based attention training program

Behavioral: Attention Bias Modification

Placebo Attention Task

PLACEBO COMPARATOR

The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.

Behavioral: Placebo Attention Task

Interventions

Attention Bias Modification BEHAVIORAL

At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.

Attention Bias Modification

Placebo Attention Task BEHAVIORAL

At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.

Placebo Attention Task

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• completed a 12-14 week cognitive behavioral therapy for anxiety
• a primary DSM-IV diagnosis of generalized anxiety disorder, social anxiety disorder, or separation anxiety disorder
• if other psychiatric disorders are present, they must be treated with medication and stable

You may not qualify if:

• meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation
• a high likelihood of harming self or others
• not been living with a primary caregiver for at least 6 months who is legally able to give consent for the child's participation
• previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services;
• involved currently in another psychosocial/behavioral treatment
• a serious vision problem that is not corrected with prescription lenses
• a physical disability that interferes with the ability to click a mouse button rapidly and repeatedly

Sponsors & Collaborators

• Florida International University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Florida International University Center for Children and Families

Miami, Florida, 33199, United States

Location

Related Publications (1)

• Pettit JW, Bechor M, Rey Y, Vasey MW, Abend R, Pine DS, Bar-Haim Y, Jaccard J, Silverman WK. A Randomized Controlled Trial of Attention Bias Modification Treatment in Youth With Treatment-Resistant Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Jan;59(1):157-165. doi: 10.1016/j.jaac.2019.02.018. Epub 2019 Mar 13.

  PMID: 30877049 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Jeremy W. Pettit (PI)
• Organization: Florida International University

jpettit@fiu.edu

305-348-1671

Study Officials

• Jeremy Pettit, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

• Wendy Silverman, PhD

  Yale Child Study Centery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 27, 2013
• Study Start: April 1, 2013
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: October 18, 2017
• Results First Posted: August 14, 2017

Record last verified: 2017-09

Locations

US (1)