Attention Control Training for PTSD in Children

Sponsor
Creighton University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03348540
Collaborator
(none)
60
1
2
72
0.8

Study Details

Study Description

Brief Summary

Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two faces on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the faces. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Attention Control Training
  • Behavioral: Comparison Task
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Randomized Clinical Trial of Attention Control Training for Symptoms of PTSD in Children
Actual Study Start Date :
Nov 20, 2017
Anticipated Primary Completion Date :
Nov 20, 2023
Anticipated Study Completion Date :
Nov 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Attention Control Training

6 sessions in the clinic lasting approximately 10 minutes each. Each session will consist of 128 presentations of pairs of neutral and threatening stimuli, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard).

Behavioral: Attention Control Training
Attention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015).

Placebo Comparator: Comparison Task

6 sessions in the clinic of a presumably inactive neutral-neutral stimuli intervention lasting approximately 10 minutes each. • Each session will consist of 128 presentations of pairs of faces, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard).

Behavioral: Comparison Task
Neutral- neutral stimuli prior to response task

Outcome Measures

Primary Outcome Measures

  1. Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test [10 minute long administration, given twice to measure change scores from pre and post training approximately 1 month apart]

    PTSD self-report questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • significant symptoms of PTSD and qualifying traumatic event
Exclusion Criteria:
  • new traumatic event within one month of beginning the trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 Creighton Univeristy Omaha Nebraska United States 68178

Sponsors and Collaborators

  • Creighton University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amy Badura Brack, Professor of Psychology, Creighton University
ClinicalTrials.gov Identifier:
NCT03348540
Other Study ID Numbers:
  • 1123267
First Posted:
Nov 21, 2017
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 18, 2022