NCT02425280

Brief Summary

This study aims to understand how war trauma affects children's and adolescents' memory functions and mental health, and whether Narrative Exposure Therapy is effective in enhancing optimal memory functions and alleviating mental health problems. The study analyzes the mental health and cognitive and emotional healing mechanisms of therapeutic intervention among war-affected children and adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

3.4 years

First QC Date

April 15, 2015

Last Update Submit

October 15, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • Post-traumatic Stress as measured by Revised Impact of Event Scale

    9 months

  • Depression as measured by Depression Self-Rating Scale for Children

    9 months

  • Psychological Distress as measured by Strengths and Difficulties Questionnaire

    9 months

  • Resilience as measured by Child and Youth Resilience Measure

    9 months

  • Cognitive Performance as measured by Working Memory Test Battery for Children

    9 months

Secondary Outcomes (3)

  • Quality of Traumatic Memory as measured by Trauma Memory Quality Questionnaire

    9 months

  • Trauma Related Cognitions as measured by Children's Post Traumatic Cognitions Inventory

    9 months

  • General functioning of autobiographical memory as measured by reported life events

    9 months

Other Outcomes (2)

  • Subjective distress during therapy measured by Subjective Units of Distress Scale

    9 months

  • Peritraumatic Dissociation measured by Peritraumatic Dissociative Experiences Questionnaire

    once, at baseline

Study Arms (2)

Narrative Exposure Therapy

EXPERIMENTAL

For the intervention group receiving Narrative Exposure Therapy treatment, the intervention will last for approximately three months and include 10-12 weekly sessions of 60-90 minutes. The course of the intervention will follow the NET manual (Schauer et al., 2011).

Behavioral: Narrative Exposure Therapy

Treatment as Usual

ACTIVE COMPARATOR

For the TAU control group, participants will receive the usual care for posttraumatic stress symptoms currently offered by each unit.

Behavioral: Treatment as Usual

Interventions

Narrative Exposure Therapy
Treatment as Usual

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • has spent some part of her/his life living in a country where organized violence was taking place, or at a refugee camp
  • suffers from significant stress symptoms thought be trauma-related

You may not qualify if:

  • acute psychosis
  • intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre for Torture Survivors

Helsinki, Finland

Location

Family Counselling Centre of the City of Tampere

Tampere, Finland

Location

Psychiatric Clinic for Traumatized Children at Tampere University Hospital

Tampere, Finland

Location

Related Publications (1)

  • Kangaslampi S, Garoff F, Peltonen K. Narrative exposure therapy for immigrant children traumatized by war: study protocol for a randomized controlled trial of effectiveness and mechanisms of change. BMC Psychiatry. 2015 Jun 17;15:127. doi: 10.1186/s12888-015-0520-z.

MeSH Terms

Interventions

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 23, 2015

Study Start

November 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations