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:
Uni Research
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 31, 2012 | ||||||||
| Last Updated Date | February 21, 2013 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Children's Revised Impact of Event Scale (CRIES) [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01612104 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Child Post-Traumatic Cognition Inventory (CPTCI) [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Psychological First Aid With Children in a High Risk Group - a Repeated Single Case ABA Design | ||||||||
| Official Title ICMJE | Psychological First Aid With Children in a High Risk Group - a Repeated Single Case ABA Design | ||||||||
| 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 ("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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: Psycholigial First Aid
Intervention: Behavioral: Psychological First Aid |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 12 | ||||||||
| Estimated Completion Date | July 2014 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Children/adolescents with:
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| Gender | Both | ||||||||
| Ages | 11 Years to 16 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01612104 | ||||||||
| Other Study ID Numbers ICMJE | RKBU62 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Uni Research | ||||||||
| Study Sponsor ICMJE | Uni Research | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Uni Research | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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