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

This study is currently recruiting participants.
Verified February 2013 by Uni Research
Sponsor:
Collaborators:
The Norwegian Directorate of Health
Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
Information provided by (Responsible Party):
Uni Research
ClinicalTrials.gov Identifier:
NCT01612104
First received: May 31, 2012
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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 ("Statens Barnehus 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 Intervention Phase
Post Traumatic Stress Disorder
Adjustment Disorder
 Behavioral: Psychological First Aid
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychological First Aid With Children in a High Risk Group - a Repeated Single Case ABA Design

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uni Research:

Primary Outcome Measures:
  • Children's Revised Impact of Event Scale (CRIES) [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child Post-Traumatic Cognition Inventory (CPTCI) [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psycholigial First Aid 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

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children/adolescents that:

    • contact "Barnehuset i 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612104

Contacts
Contact: Solfrid Raknes, Psychologist +47 41617343 solfrid.raknes@hotmail.com
Contact: Bente SM Haugland, Ph.D +47 97582317 bente.haugland@uni.no

Locations
Norway
Barnehuset in Oslo Recruiting
Oslo, Norway
Contact: Astrid J Pettersen            
Contact: Shirley Stormoen, Psychologist            
Sub-Investigator: Solfrid Raknes, Psychologist            
Sponsors and Collaborators
Uni Research
The Norwegian Directorate of Health
Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
Investigators
Principal Investigator: Bente SM Haugland, PhD Centre for Child and Adolescent Mental Health, Western Norway
  More Information

No publications provided

Responsible Party: Uni Research
ClinicalTrials.gov Identifier: NCT01612104     History of Changes
Other Study ID Numbers: RKBU62
Study First Received: May 31, 2012
Last Updated: February 21, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Uni Research:
Post Traumatic Stress Disorder
Anxiety symptoms
Depressive symptoms
Externalizing behavior
Reduced quality of life

Additional relevant MeSH terms:
Adjustment Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 23, 2013