Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for... | NCT00635752

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

NCT00635752

Sponsor

Norwegian Center for Violence and Traumatic Stress Studies

Status

Completed

Last Update Posted

Apr 23, 2015Estimated

Enrollment

156Actual

Phase

Not Applicable

Conditions

Post-Traumatic Stress Disorder

Interventions

TF-CBT
Treatment as Usual (TAU)

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Aug 2013Actual

First Submitted Date

Mar 11, 2008

First Submission Date that Met QC Criteria

Mar 13, 2008

First Posted Date

Mar 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2015

Last Update Posted Date

Apr 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tine K. Jensen, Professor, Norwegian Center for Violence and Traumatic Stress StudiesPrincipal Investigator

Lead Sponsor

Norwegian Center for Violence and Traumatic Stress StudiesOTHER

Collaborators

Name	Class
Norway: Directorate for Health and Social Affairs	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Participants will receive trauma-focused cognitive behavioral therapy (TF-CBT)	Other: TF-CBT
2	Active Comparator	Participants will receive sessions of treatment as usual (TAU)	Other: Treatment as Usual (TAU)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TF-CBT	Other	TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tine K Jensen, PhD	Norwegian Centre for Violence and Traumatic Stress Studies	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian center for violence and traumatic stress studies		Oslo			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24712976	Background	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.
24367942	Background

ID	Term
D013313	Stress Disorders, Post-Traumatic
D014947	Wounds and Injuries

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders