NCT00635752

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

March 11, 2008

Last Update Submit

April 22, 2015

Conditions

Post-Traumatic Stress Disorder

Keywords

TF-CBTEffectiveness studyTraumaTherapy

Outcome Measures

Primary Outcomes (1)

  • PTSD

    Before session, middle, end, one year follow-up, 18 month follow-up

Secondary Outcomes (2)

  • Parent distress

    Before session, middle, end, one year follow-up, 18 month follow-up

  • Therapeutic alliance

    After 1st. and 6th. session

Study Arms (2)

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

TF-CBTOTHER

TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.

1
Treatment as Usual (TAU)OTHER

Participants will receive regular therapy as is usually practiced in clinics

Also known as: TAU
2

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe psychosis
  • Severe mental retardation.
  • The youth must not have had severe conduct disorders previous to the trauma experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian center for violence and traumatic stress studies

Oslo, Norway

Location

Related Publications (14)

  • 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.

    PMID: 24712976BACKGROUND

  • 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.

    PMID: 24367942BACKGROUND

  • 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.

    PMID: 23895084BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 23931093RESULT

  • 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.

    PMID: 23548683RESULT

  • 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.

    PMID: 24361907RESULT

  • 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.

    PMID: 36125352DERIVED

  • 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.

    PMID: 34893017DERIVED

  • 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.

    PMID: 31928035DERIVED

  • 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.

    PMID: 31343205DERIVED

  • 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.

    PMID: 30408700DERIVED

  • 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.

    PMID: 29877724DERIVED

  • 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.

    PMID: 29543473DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Tine K Jensen, PhD

    Norwegian Centre for Violence and Traumatic Stress Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 14, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2011

Study Completion

August 1, 2013

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

NO(1)