Back to resultsPsychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Primary Purpose
Post Traumatic Stress Disorder, Adjustment Disorder
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Psychological First Aid
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, Anxiety symptoms, Depressive symptoms, Externalizing behavior, Reduced quality of life
Eligibility Criteria
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
Sites / Locations
- The Children's House in Oslo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psychological First Aid
Arm Description
Psychological material developed for children and adolescents, based on cognitive behavioral theory, used to structure therapeutic conversations and/or for self-help.
Outcomes
Primary Outcome Measures
Children's Revised Impact of Event Scale (CRIES)
Secondary Outcome Measures
Child Post-Traumatic Cognition Inventory (CPTCI)
Full Information
NCT ID
NCT01612104
First Posted
May 31, 2012
Last Updated
December 4, 2015
Sponsor
NORCE Norwegian Research Centre AS
1. Study Identification
Unique Protocol Identification Number
NCT01612104
Brief Title
Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Official Title
Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Adjustment Disorder
Keywords
Post Traumatic Stress Disorder, Anxiety symptoms, Depressive symptoms, Externalizing behavior, Reduced quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychological First Aid
Arm Type
Experimental
Arm Description
Psychological material developed for children and adolescents, based on cognitive behavioral theory, used to structure therapeutic conversations and/or for self-help.
Intervention Type
Behavioral
Intervention Name(s)
Psychological First Aid
Intervention Description
A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma
Primary Outcome Measure Information:
Title
Children's Revised Impact of Event Scale (CRIES)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Child Post-Traumatic Cognition Inventory (CPTCI)
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente SM Haugland, PhD
Organizational Affiliation
Centre for Child and Adolescent Mental Health, Western Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's House in Oslo
City
Oslo
Country
Norway
12. IPD Sharing Statement
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Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
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