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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612104
• Other study ID #: RKBU62
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2012
• Last updated: December 4, 2015
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Uni Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adjustment Disorder
• Adjustment Disorders
• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Norway	The Children's House in Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Uni Research

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Revised Impact of Event Scale (CRIES)		One year	No
Secondary	Child Post-Traumatic Cognition Inventory (CPTCI)		One year	No