Attention Training for Underserved Youth With Anxiety

NCT03028792 | Completed

• 1 other identifier: IRB#15-000334
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the efficacy and feasibility of administering a computerized attention training program targeting clinical levels of anxiety in Latino youth between the ages of 8-17. 52 youth from Imperial County, a rural and predominantly Latino region, will be randomized to receive either 1) a 12-session attention modification program (AMP) or 2) an attention condition program (non-active treatment). Clinical assessment of symptom severity will be conducted before, during, and after treatment. We hypothesize that at the end of treatment, children who receive the active intervention (AMP) will show (1) decreased attention bias to anxiety-related triggers using an independent measure of attention bias to assess change and (b) reduced anxiety severity. We also hypothesize that this study will be feasible, tolerable, acceptable, and safe in this underserved sample of Latino youth. This study is an initial step towards demonstrating the feasibility of implementing a novel computerized attention training program in anxiety in underserved community samples.

Conditions

Anxiety

Keywords

attention training, youth, latino

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Global Impression-Severity (CGI-S) and Improvement, (CGI-I) Scales, Pre- to Post-Treatment

  Participants receiving a post-treatment CGI-I score of 1 (very much improved) or 2 (much improved) on this one-item, 7-point rating will be considered treatment responders.

  through study completion, average of 4 weeks

Secondary Outcomes (4)

• Change in Attention Network Task Pre- to Post-Treatment

  through study completion, average of 4 weeks

• Change in Visual search task Pre to Post-Treatment

  through study completion, average of 4 weeks

• Change in Pediatric Anxiety Rating Scale Pre to Post-treatment

  through study completion, average of 4 weeks

• Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Pre- to Post-Treatment

  through study completion, average of 4 weeks

Study Arms (2)

Attention Modification Training

EXPERIMENTAL

Attention Modification Program Active computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief. AMP is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. This paradigm has been modified to facilitate an attention bias away from threatening material. In this case, the probe always replaces the neutral stimuli.

Behavioral: Attention Modification Program

Attention Control Training

SHAM COMPARATOR

Placebo Comparator: Attention Control Condition Control computer-based attention training task, which is not designed to modify biased attention patterns in anxious patients. ACC is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. In this case, the probe randomly replaces the neutral stimuli or the threat stimuli.

Behavioral: Attention Control Condition

Interventions

Attention Modification Program BEHAVIORAL

Each trial begins with a fixation cross at the center of the computer screen for 500 ms. The cross is then replaced by a face pair presented in the center of the screen. The face pair disappears and a probe (letter "E" or "F") appears immediately in the location of one of the two previous stimuli. Youth will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm has been modified to facilitate an attention bias away from threat material. In this case, the probe always replaces the neutral stimuli. Thus, although there will be no specific instruction to direct attention away from the threat stimuli, on all trials, the position of the neutral stimulus will indicate the position of the probe.

Also known as: ABM, attention bias modification, attention training

Attention Modification Training

Attention Control Condition BEHAVIORAL

Each trial begins with a fixation cross presented in the center of the computer screen. The cross is then replaced by a face pair presented in the center of the screen. The face pair disappears and a probe (letter "E" or "F") appears immediately in the location of one of the two previous stimuli. Youth will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm is not intended to facilitate an attention bias away from threat material. In this case, the probe randomly replaces the threat or neutral stimulus.

Also known as: ACC

Attention Control Training

Eligibility Criteria

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

You may qualify if:

• \. Children and parents of children ages 8 through 17 inclusive at the time of initial evaluation 2. Clinically significant levels of anxiety as measured by self-report 3. Unmedicated or on stable medication treatment for at least 6 weeks prior to study entry, with no planned changes for duration of study participation.
• \. Child is fluent English or Spanish speaker, given that all of our assessments as well as the language-based treatment protocol have thus far only been validated in English and Spanish.
• \. Parental Informed Consent and Child Informed Assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.
• \. Child self-identifies as Latino/Hispanic

You may not qualify if:

• Excessive or Problematic Substance Use as reported per initial telephone screening, or significant disruptive behavior problems within the past 3 months.
• Indication of clinically significant suicidality, mania, or psychotic disorder.
• Any serious psychiatric, psychosocial, or neurological condition (i.e., ADHD, tourettes, anxiety, severe aggression) requiring immediate treatment.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Clinicas de Salud del Pueblo healthcare system

El Centro, California, 92243, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Susanna Chang, PhD

  UCLA Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Denise Chavira, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 23, 2017
• Study Start: September 1, 2017
• Primary Completion: April 12, 2020
• Study Completion: June 15, 2020
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)