Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Trauma focused cognitive behavioral therapy (TF-CBT)is more effective in the treatment of traumatized youth than treatment as usual(TAU).

Detailed Description
-----------------
Children experiencing traumas, such as sexual abuse, physical abuse, domestic violence, serious accidents, or natural disasters, may develop severe health problems. This study will examine the short and long-term effects of trauma-focused cognitive-behavioural therapy on children exposed to serious trauma, and moderating factors of treatment outcome. The study will use a random control design, and will be implemented in regular clinical practice in Norway. More knowledge within this field is important for practitioners as well as policy makers in planning interventions and therapy for children and their caregivers.

Official Title
-----------------
Trauma-focused Cognitive-behavioural Therapy for Children: A Study of Process and Outcome.

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Other: TF-CBT
* Other: Treatment as Usual (TAU)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the age of 10-18 referred to a guidance clinic who have experienced trauma present with PTSD reactions participants and the primary caretaker must be able to speak Norwegian. Exclusion Criteria: Severe psychosis Severe mental retardation. The youth must not have had severe conduct disorders previous to the trauma experience

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive trauma-focused cognitive behavioral therapy (TF-CBT) | Other: TF-CBT<br>* TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.<br>|
| Active Comparator: 2<br>Participants will receive sessions of treatment as usual (TAU) | Other: Treatment as Usual (TAU)<br>* Participants will receive regular therapy as is usually practiced in clinics<br>* Other names: TAU;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD |  | Before session, middle, end, one year follow-up, 18 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent distress |  | Before session, middle, end, one year follow-up, 18 month follow-up | 
| Therapeutic alliance |  | After 1st. and 6th. session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TF-CBT, Effectiveness study, Trauma, Therapy