Post-Traumatic Stress DisorderNCT00635752
Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.
A study testing TF-CBT and Treatment as Usual (TAU) in people with Post-Traumatic Stress Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- TF-CBT and Treatment as Usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2008to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Severe psychosis
- Severe mental retardation.
- The youth must not have had severe conduct disorders previous to the trauma experience
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trauma-focused Cognitive-behavioural Therapy for Children: A Study of Process and Outcome.
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).
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- TF-CBT, Treatment as Usual (TAU)
- Keywords
- TF-CBT, Effectiveness study, Trauma, Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF-CBTOther
TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.
Also called TAU
Participants will receive regular therapy as is usually practiced in clinics
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive trauma-focused cognitive behavioral therapy (TF-CBT) Receives: Other: TF-CBT |
| 2 | Active comparator | Participants will receive sessions of treatment as usual (TAU) Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
Measured: Before session, middle, end, one year follow-up, 18 month follow-up
Secondary outcomes (2)
Parent distress
Measured: Before session, middle, end, one year follow-up, 18 month follow-up
Therapeutic alliance
Measured: After 1st. and 6th. session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Norway: Directorate for Health and Social Affairs
- Responsible party
- Principal investigator, Tine K. Jensen, Norwegian Center for Violence and Traumatic Stress Studies
- Investigators
- Tine K Jensen, PhD, Principal investigator, Norwegian Centre for Violence and Traumatic Stress Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635752
- Sponsor's protocol ID
- s-07442a(REK)
- Status last verified
- Apr 2015
- First submitted
- 11 Mar 2008
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24712976Dittmann 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.
PubMed 24367942Ormhaug 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.
PubMed 23895084Holt, 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
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.
PubMed 23931093Glad 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.
PubMed 23548683Hukkelberg 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.
PubMed 24361907Ovenstad 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.
PubMed 36125352Ovenstad 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.
PubMed 34893017Ovenstad 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.
PubMed 31928035Lindebo 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.
PubMed 31343205Knutsen 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.
PubMed 30408700Aas 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.
PubMed 29877724Jensen 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.
PubMed 29543473
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-focused Cognitive-behavioural Therapy for Children: A Study of Process and Outcome.
- ClinicalTrials.gov ID
- NCT00635752
- Acronym / sponsor ID
- s-07442a(REK)
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- TF-CBT, Effectiveness study, Trauma, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress StudiesUniversity, hospital or other
- Collaborators
- Norway: Directorate for Health and Social Affairs
- Study start
- Apr 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: TF-CBTParticipants will receive trauma-focused cognitive behavioral therapy (TF-CBT) |
| 2 | Active comparator | Other: Treatment as Usual (TAU)Participants will receive sessions of treatment as usual (TAU) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Severe psychosis
- Severe mental retardation.
- The youth must not have had severe conduct disorders previous to the trauma experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TF-CBTTF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills. | Other | 1 |
| Treatment as Usual (TAU)Also: TAUParticipants will receive regular therapy as is usually practiced in clinics | Other | 2 |
Primary outcome
PTSD
Time frame: Before session, middle, end, one year follow-up, 18 month follow-up
2 secondary outcomes
Parent distress
Time frame: Before session, middle, end, one year follow-up, 18 month follow-up
Therapeutic alliance
Time frame: After 1st. and 6th. session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Background: PubMed 24712976Holt 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.
- Background: PubMed 24367942Dittmann 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.
- Background: PubMed 23895084Ormhaug 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.
- BackgroundHolt, 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 publication: PubMed 23931093Jensen 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 publication: PubMed 23548683Glad 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 publication: PubMed 24361907Hukkelberg 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.
- Derived from this study: PubMed 36125352Ovenstad 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.
- Derived from this study: PubMed 34893017Ovenstad 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.
- Derived from this study: PubMed 31928035Ovenstad 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.
- Derived from this study: PubMed 31343205Lindebo 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.
- Derived from this study: PubMed 30408700Knutsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tine K Jensen, PhD principal investigator
Norwegian Centre for Violence and Traumatic Stress Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TF-CBT and Treatment as Usual (TAU) in people with Post-Traumatic Stress Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD (time frame: Before session, middle, end, one year follow-up, 18 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635752, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.