Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety

NCT02410967 | Completed Results DMC

• 1 other identifier: UH2MH101470
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pilot test of Attention Bias Modification Training (ABMT) among clinic referred children and adolescents with subthreshold impairing anxiety (i.e., anxiety and related impairment that fails to meet criteria for an anxiety disorder diagnosis). Half of participants will receive 8 sessions of computer administered ABMT and the other half of participants will receive a 8 sessions of a computer administered control task.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• Pediatric Anxiety Rating Scale at Posttreatment

  posttreatment clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.

  7 days

• Pediatric Anxiety Rating Scale at Follow-up

  follow-up clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.

  7 days

Secondary Outcomes (4)

• Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment

  14 days

• Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up

  14 days

• Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment

  14 days

• Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up

  14 days

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
• meet criteria for subthreshold impairing anxiety

You may not qualify if:

• meet diagnostic criteria for Anxiety Disorder, 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

Study Sites (1)

Florida International University Center for Children and Families

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Jeremy Pettit
• Organization: Florida International University

jpettit@fiu.edu

305-348-1671

Study Officials

• Jeremy Pettit, PhD

  Florida International University

  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, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: April 8, 2015
• Study Start: July 1, 2014
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-05

Locations

US (1)