- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03348540
Attention Control Training for PTSD in Children
February 6, 2024 updated by: Amy Badura Brack, Creighton University
Randomized Clinical Trial of Attention Control Training for Symptoms of PTSD in Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68178
- Creighton Univeristy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 15 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- significant symptoms of PTSD and qualifying traumatic event
Exclusion Criteria:
- new traumatic event within one month of beginning the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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). |
Neutral- neutral stimuli prior to response task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test
Time Frame: 10 minute long administration, given twice to measure change scores from pre and post training approximately 1 month apart
|
PTSD self-report questionnaire
|
10 minute long administration, given twice to measure change scores from pre and post training approximately 1 month apart
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2017
Primary Completion (Actual)
November 20, 2023
Study Completion (Actual)
November 20, 2023
Study Registration Dates
First Submitted
November 16, 2017
First Submitted That Met QC Criteria
November 20, 2017
First Posted (Actual)
November 21, 2017
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 1123267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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