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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635752
• Other study ID #: s-07442a(REK)
• Status: Completed
• Phase: N/A
• First received: March 11, 2008
• Last updated: April 22, 2015
• Start date: April 2008
• Est. completion date: August 2013

Study information

• Verified date: April 2015
• Source: Norwegian Center for Violence and Traumatic Stress Studies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Other:
• TF-CBT
TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.
• Treatment as Usual (TAU)
Participants will receive regular therapy as is usually practiced in clinics

Locations

Country	Name	City	State
Norway	Norwegian center for violence and traumatic stress studies	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Center for Violence and Traumatic Stress Studies	Norway: Directorate for Health and Social Affairs

Country where clinical trial is conducted

Norway, 

References & Publications (7)

Dittmann I, Jensen TK. Giving a voice to traumatized youth-experiences with Trauma-Focused Cognitive Behavioral Therapy. Child Abuse Negl. 2014 Jul;38(7):1221-30. doi: 10.1016/j.chiabu.2013.11.008. Epub 2013 Dec 22. — View Citation

Glad KA, Jensen TK, Holt T, Ormhaug SM. Exploring self-perceived growth in a clinical sample of severely traumatized youth. Child Abuse Negl. 2013 May;37(5):331-42. doi: 10.1016/j.chiabu.2013.02.007. Epub 2013 Mar 30. — View Citation

Holt T, Jensen TK, Wentzel-Larsen T. The change and the mediating role of parental emotional reactions and depression in the treatment of traumatized youth: results from a randomized controlled study. Child Adolesc Psychiatry Ment Health. 2014 Apr 8;8:11. doi: 10.1186/1753-2000-8-11. eCollection 2014. — View Citation

Holt, T., Cohen, J. A., Mannarino, A., & Jensen, T. K. (2014). Parental Emotional Response to Children's Traumas. Journal of Aggression, Maltreatment & Trauma. 23(10), 1057-1071. doi: 10.1080/10926771.2014.953717

Hukkelberg S, Ormhaug SM, Holt T, Wentzel-Larsen T, Jensen TK. Diagnostic utility of CPSS vs. CAPS-CA for assessing posttraumatic stress symptoms in children and adolescents. J Anxiety Disord. 2014 Jan;28(1):51-6. doi: 10.1016/j.janxdis.2013.11.001. Epub — View Citation

Jensen TK, Holt T, Ormhaug SM, Egeland K, Granly L, Hoaas LC, Hukkelberg SS, Indregard T, Stormyren SD, Wentzel-Larsen T. A randomized effectiveness study comparing trauma-focused cognitive behavioral therapy with therapy as usual for youth. J Clin Child — View Citation

Ormhaug SM, Jensen TK, Wentzel-Larsen T, Shirk SR. The therapeutic alliance in treatment of traumatized youths: relation to outcome in a randomized clinical trial. J Consult Clin Psychol. 2014 Feb;82(1):52-64. doi: 10.1037/a0033884. Epub 2013 Jul 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD		Before session, middle, end, one year follow-up, 18 month follow-up	No
Secondary	Parent distress		Before session, middle, end, one year follow-up, 18 month follow-up	No
Secondary	Therapeutic alliance		After 1st. and 6th. session	No