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Completed

NCT Number: NCT01612104

Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design

The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological First Aid" used with a group of children (11-16 years) in high risk of developing psychological problems. Participants are recruited from a low-threshold program ("The Children's House in Oslo") where counseling is given to children suspected of being physically or sexually abused, or having witnessed domestic violence. The study includes twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be assessed daily.

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Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Children's House in Oslo

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children/adolescents that:
  • contact "The Children's House in Oslo" after having experienced potential traumatic event(s).
  • are assessed as having psychological symptoms related to potential trauma
  • are between 11 and 16 years old
  • agree to participate in the study (both the youth and his/her parents(s)
  • understand and speak Norwegian

Exclusion criteria

  • Children/adolescents with:
  • mental retardation
  • reading skills below 8 year
  • psychosis
  • high risk of suicidal behavior is assumed

Treatment and study plan

psychological first aid

Behavioral

A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma

Primary outcomes

  1. Children's Revised Impact of Event Scale (CRIES)

    Time frame: One year

Secondary outcomes

  1. Child Post-Traumatic Cognition Inventory (CPTCI)

    Time frame: One year

Sponsors and collaborators

Lead sponsor

NORCE Norwegian Research Centre AS

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Jun 5, 2012
Registry last updated
Dec 7, 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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