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

NCT01612104 | Completed Phase 1

• 1 other identifier: RKBU62
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder; Adjustment Disorder

Keywords

Post Traumatic Stress Disorder; Anxiety symptoms; Depressive symptoms; Externalizing behavior; Reduced quality of life

Outcome Measures

Primary Outcomes (1)

• Children's Revised Impact of Event Scale (CRIES)

  One year

Secondary Outcomes (1)

• Child Post-Traumatic Cognition Inventory (CPTCI)

  One year

Study Arms (1)

Psychological First Aid

EXPERIMENTAL

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

Interventions

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

Psychological First Aid

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: lead

Study Sites (1)

The Children's House in Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Adjustment Disorders; Anxiety Disorders; Depression

Interventions

Psychological First Aid

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Emergency Services, Psychiatric; Mental Health Services; Behavioral Disciplines and Activities

Study Officials

• Bente SM Haugland, PhD

  Centre for Child and Adolescent Mental Health, Western Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 5, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

NO (1)