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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uni Research
ClinicalTrials.gov Identifier:
NCT01612104
First received: May 31, 2012
Last updated: December 4, 2015
Last verified: December 2015

May 31, 2012
December 4, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01612104 on ClinicalTrials.gov Archive Site
Child Post-Traumatic Cognition Inventory (CPTCI) [ Time Frame: One year ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
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
Both
11 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01612104
RKBU62
No
Not Provided
Not Provided
Uni Research
Uni Research
Not Provided
Principal Investigator: Bente SM Haugland, PhD Centre for Child and Adolescent Mental Health, Western Norway
Uni Research
December 2015

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