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

Study Overview
=================
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.

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

Conditions
-----------------
Post Traumatic Stress Disorder, Adjustment Disorder

Intervention / Treatment
-----------------
* Behavioral: Psychological First Aid


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological First Aid<br>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<br>* A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Revised Impact of Event Scale (CRIES) |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Post-Traumatic Cognition Inventory (CPTCI) |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Traumatic Stress Disorder, Anxiety symptoms, Depressive symptoms, Externalizing behavior, Reduced quality of life