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

December 4, 2015 updated by: NORCE Norwegian Research Centre AS
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • The Children's House in Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychological First Aid
Psychological material developed for children and adolescents, based on cognitive behavioral theory, used to structure therapeutic conversations and/or for self-help.
Behavioral: Psychological First Aid
A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Children's Revised Impact of Event Scale (CRIES)
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Child Post-Traumatic Cognition Inventory (CPTCI)
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NORCE Norwegian Research Centre AS

Investigators

  • Principal Investigator: Bente SM Haugland, PhD, Centre for Child and Adolescent Mental Health, Western Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RKBU62

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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