Clinical trial NCT02410967: Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety
Official title: Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 53
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study will collect preliminary data on Attention Bias Modification Training (ABMT) among clinic referred children and adolescents who display subthreshold impairing anxiety (SubImpAnx; anxiety \& related impairment that fails to meet diagnostic criteria for an anxiety disorder). Traditional approaches to mental health service delivery cannot meet current demand. The inadequacies of traditional service delivery are magnified when viewed through the lens of impaired but undiagnosed youth. It is an unaddressed empirical question whether a least restrictive treatment can effectively reduce SubImpAnx in youth. Empirical efforts to address this issue are important because youths with SubImpAnx experience substantial impairment, are at high risk of escalation to full syndrome anxiety disorder, and pose a burden on the health care system.

This study will enroll 66 clinic referred children and adolescents (ages 8-16 years) who meet criteria for SubImpAnx. Participants will be randomly assigned to complete 8 sessions of either ABMT or a placebo control (PC) task over 4 weeks. Clinician ratings on youth anxiety severity and impairment will be evaluated as the primary outcome. Youth self ratings and parent ratings on youth anxiety symptoms and impairment will be evaluated as secondary outcomes. All measures will be collected before condition assignment (pretreatment), at immediate posttreatment, and at an 8 week follow up. In addition, initial data will be collected to shed light on whether it would be useful to pursue (a) attention bias to threat as a mediator of ABMT's anxiety reduction effects and (b) dose-response issues related to ABMT's anxiety reduction effects in a subsequent, larger study.

The specific aims are: Collect pilot data on the effects of ABMT and a PC task on levels of anxiety and impairment at a post evaluation (Aim 1) and at a follow up (FU) evaluation 8 weeks after the post evaluation (Aim 2); Preliminarily examine whether ABMT leads to lower levels of attention bias toward threatening stimuli as compared to a PC Task at post and 8 week FU (Aim 3); Describe the course of anxiety symptoms and impairment during treatment among youth in the ABMT condition (Aim 4).

This project will provide critically needed pilot data on ABMT for youth with SubImpAnx. With these data in hand, the field will be in a better position to determine whether ABMT may be used as a least restrictive intervention among anxious youth who are 'impaired but undiagnosed.'

Eligibility criteria: Inclusion Criteria:

* 8-16 years old
* meet criteria for subthreshold impairing anxiety

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pediatric Anxiety Rating Scale at Posttreatment
timeFrame: 7 days
measure: Pediatric Anxiety Rating Scale at Follow-up
timeFrame: 7 days
Secondary outcomes:
measure: Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment
timeFrame: 14 days
measure: Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up
timeFrame: 14 days
measure: Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment
timeFrame: 14 days
measure: Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up
timeFrame: 14 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University Center for Children and Families
state: Florida
Study officials:
affiliation: Florida International University
name: Jeremy Pettit, PhD
role: PRINCIPAL_INVESTIGATOR
References: