Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01612104
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : December 7, 2015
Information provided by (Responsible Party):
NORCE Norwegian Research Centre AS

May 31, 2012
June 5, 2012
December 7, 2015
March 2012
July 2013   (Final data collection date for primary outcome measure)
Children's Revised Impact of Event Scale (CRIES) [ Time Frame: One year ]
Same as current
Complete list of historical versions of study NCT01612104 on Archive Site
Child Post-Traumatic Cognition Inventory (CPTCI) [ Time Frame: One year ]
Same as current
Not Provided
Not Provided
Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological First Aid" used with a group of children (11-16 years) in high risk of developing psychological problems. Participants are recruited from a low-threshold program ("The Children's House in Oslo") where counseling is given to children suspected of being physically or sexually abused, or having witnessed domestic violence. The study includes twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be assessed daily.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Post Traumatic Stress Disorder
  • Adjustment Disorder
Behavioral: Psychological First Aid
A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma
Experimental: Psychological First Aid
Psychological material developed for children and adolescents, based on cognitive behavioral theory, used to structure therapeutic conversations and/or for self-help.
Intervention: Behavioral: Psychological First Aid
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2015
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children/adolescents that:

    • contact "The Children's House in Oslo" after having experienced potential traumatic event(s).
    • are assessed as having psychological symptoms related to potential trauma
    • are between 11 and 16 years old
    • agree to participate in the study (both the youth and his/her parents(s)
  • understand and speak Norwegian

Exclusion Criteria:

- Children/adolescents with:

  • mental retardation
  • reading skills below 8 year
  • psychosis
  • high risk of suicidal behavior is assumed
Sexes Eligible for Study: All
11 Years to 16 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
NORCE Norwegian Research Centre AS
NORCE Norwegian Research Centre AS
Not Provided
Principal Investigator: Bente SM Haugland, PhD Centre for Child and Adolescent Mental Health, Western Norway
NORCE Norwegian Research Centre AS
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP