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Completed

NCT Number: NCT00635752

Trauma-focused Cognitive-behavioural Therapy(TF-CBT) 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).

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian center for violence and traumatic stress studies

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TF-CBT

Other

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

Treatment as usual (TAU)

Other

Participants will receive regular therapy as is usually practiced in clinics

Other names: TAU

Primary outcomes

  1. PTSD

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

Secondary outcomes

  1. Parent distress

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

  2. Therapeutic alliance

    Time frame: After 1st. and 6th. session

Sponsors and collaborators

Lead sponsor

Norwegian Center for Violence and Traumatic Stress Studies

Other

Collaborators

  • Norway: Directorate for Health and Social Affairs

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Mar 14, 2008
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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