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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Adjustment Disorder Behavioral: Psychological First Aid Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Study Start Date : March 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: First Aid

Arm Intervention/treatment
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.
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

Primary Outcome Measures :
  1. Children's Revised Impact of Event Scale (CRIES) [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Child Post-Traumatic Cognition Inventory (CPTCI) [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01612104

The Children's House in Oslo
Oslo, Norway
Sponsors and Collaborators
NORCE Norwegian Research Centre AS
Principal Investigator: Bente SM Haugland, PhD Centre for Child and Adolescent Mental Health, Western Norway

Responsible Party: NORCE Norwegian Research Centre AS Identifier: NCT01612104     History of Changes
Other Study ID Numbers: RKBU62
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Keywords provided by NORCE Norwegian Research Centre AS:
Post Traumatic Stress Disorder
Anxiety symptoms
Depressive symptoms
Externalizing behavior
Reduced quality of life

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Adjustment Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders