Back to resultsTrauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
TF-CBT
Treatment as Usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring TF-CBT, Effectiveness study, Trauma, Therapy
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
Sites / Locations
- Norwegian center for violence and traumatic stress studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive trauma-focused cognitive behavioral therapy (TF-CBT)
Participants will receive sessions of treatment as usual (TAU)
Outcomes
Primary Outcome Measures
PTSD
Secondary Outcome Measures
Parent distress
Therapeutic alliance
Full Information
NCT ID
NCT00635752
First Posted
March 11, 2008
Last Updated
April 22, 2015
Sponsor
Norwegian Center for Violence and Traumatic Stress Studies
Collaborators
Norway: Directorate for Health and Social Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00635752
Brief Title
Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.
Official Title
Trauma-focused Cognitive-behavioural Therapy for Children: A Study of Process and Outcome.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian Center for Violence and Traumatic Stress Studies
Collaborators
Norway: Directorate for Health and Social Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
TF-CBT, Effectiveness study, Trauma, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive trauma-focused cognitive behavioral therapy (TF-CBT)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive sessions of treatment as usual (TAU)
Intervention Type
Other
Intervention Name(s)
TF-CBT
Intervention Description
TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual (TAU)
Other Intervention Name(s)
TAU
Intervention Description
Participants will receive regular therapy as is usually practiced in clinics
Primary Outcome Measure Information:
Title
PTSD
Time Frame
Before session, middle, end, one year follow-up, 18 month follow-up
Secondary Outcome Measure Information:
Title
Parent distress
Time Frame
Before session, middle, end, one year follow-up, 18 month follow-up
Title
Therapeutic alliance
Time Frame
After 1st. and 6th. session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tine K Jensen, PhD
Organizational Affiliation
Norwegian Centre for Violence and Traumatic Stress Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian center for violence and traumatic stress studies
City
Oslo
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
24712976
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.
Results Reference
background
PubMed Identifier
24367942
Citation
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.
Results Reference
background
PubMed Identifier
23895084
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
23931093
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 Adolesc Psychol. 2014;43(3):356-69. doi: 10.1080/15374416.2013.822307. Epub 2013 Aug 9.
Results Reference
result
PubMed Identifier
23548683
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.
Results Reference
result
PubMed Identifier
24361907
Citation
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 2013 Dec 1.
Results Reference
result
PubMed Identifier
36125352
Citation
Ovenstad KS, Ormhaug SM, Jensen TK. The relationship between youth involvement, alliance and outcome in trauma-focused cognitive behavioral therapy. Psychother Res. 2023 Mar;33(3):316-327. doi: 10.1080/10503307.2022.2123719. Epub 2022 Sep 20.
Results Reference
derived
PubMed Identifier
34893017
Citation
Ovenstad KS, Jensen TK, Ormhaug SM. Four perspectives on traumatized youths' therapeutic alliance: Correspondence and outcome predictions. Psychother Res. 2022 Jul;32(6):820-832. doi: 10.1080/10503307.2021.2011983. Epub 2021 Dec 10.
Results Reference
derived
PubMed Identifier
31928035
Citation
Ovenstad KS, Ormhaug SM, Shirk SR, Jensen TK. Therapists' behaviors and youths' therapeutic alliance during trauma-focused cognitive behavioral therapy. J Consult Clin Psychol. 2020 Apr;88(4):350-361. doi: 10.1037/ccp0000465. Epub 2020 Jan 13.
Results Reference
derived
PubMed Identifier
31343205
Citation
Lindebo Knutsen M, Sachser C, Holt T, Goldbeck L, Jensen TK. Trajectories and possible predictors of treatment outcome for youth receiving trauma-focused cognitive behavioral therapy. Psychol Trauma. 2020 May;12(4):336-346. doi: 10.1037/tra0000482. Epub 2019 Jul 25.
Results Reference
derived
PubMed Identifier
30408700
Citation
Knutsen ML, Czajkowski NO, Ormhaug SM. Changes in posttraumatic stress symptoms, cognitions, and depression during treatment of traumatized youth. Behav Res Ther. 2018 Dec;111:119-126. doi: 10.1016/j.brat.2018.10.010. Epub 2018 Oct 27.
Results Reference
derived
PubMed Identifier
29877724
Citation
Aas E, Iversen T, Holt T, Ormhaug SM, Jensen TK. Cost-Effectiveness Analysis of Trauma-Focused Cognitive Behavioral Therapy: A Randomized Control Trial among Norwegian Youth. J Clin Child Adolesc Psychol. 2019;48(sup1):S298-S311. doi: 10.1080/15374416.2018.1463535. Epub 2018 Jun 7.
Results Reference
derived
PubMed Identifier
29543473
Citation
Jensen TK, Holt T, Morup Ormhaug S, Fjermestad KW, Wentzel-Larsen T. Change in post-traumatic cognitions mediates treatment effects for traumatized youth-A randomized controlled trial. J Couns Psychol. 2018 Mar;65(2):166-177. doi: 10.1037/cou0000258.
Results Reference
derived
Learn more about this trial
Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.
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