The main objectives of the present study are: determining short and long term effects of TF-CBT and EMDR; assessing the efficiency of these therapies; and identifying the characteristics of those children who do not respond to the given treatment.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the scores on the CAPS-CA post treatment
compared to the baseline scores (delta).
Secondary outcome
The secondary parameters are the scores regarding comorbidity on the ADIS C/P,
the scores on the RCADS, CRIES, SDQ, NOSI-K and the CPTCI immediately, six and
twelve months post treatment as well as scores on the Kidscreen 12 months post
treatment.
Background summary
Many children get involved traumatic events. The exposure to a traumatic event
may lead to post traumatic stress symptoms. Evidence based treatments for
children are needed to prevent long term impairment.
Study objective
The main objectives of the present study are: determining short and long term
effects of TF-CBT and EMDR; assessing the efficiency of these therapies; and
identifying the characteristics of those children who do not respond to the
given treatment.
Study design
The study design is a randomized comparison of TF-CBT and EMDR. A waiting list
condition may be added from a comparable study which will be conducted by prof.
dr. Goldbeck at the university of Ulm.
It concerns an open label study, meaning that the treatment condition is known
to the therapist and the patient. However to prevent biases, the researcher who
conducts the CAPS-CA interviews will not be informed about the treatment
condition (PROBE design: prospective randomized open label blinded endpoint).
Intervention
Treatment is either given in form of 8 sessions TF-CBT or EMDR.
Study burden and risks
Treatment for traumatized children involves both, TF-CBT and EMDR at the
Bascule. As such this is not unusual and there are no more risks associated
with the participation in this study as there are associated with regular
treatment. In fact both therapies aim at the reduction of post traumatic stress
symptoms and children benefit from either treatment.
The two follow-up measures at 6 and 12 months after the completion of the
treatment mean an extra burden. At both moments children are asked to
participate in interviews and complete some questionnaires. This will take
approximately 2 hours.
Furthermore, while treated, participants are asked to fill in a questionnaire
(CRIES) every two weeks. This will take about 5 minutes.
Meibergdreef 5
1105 AZ Amsterdam
NL
Meibergdreef 5
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Involvement in a single or multiple traumatic event(s).
Duration of posttraumatic stress symptoms lasts three months or longer.
Exclusion criteria
Coma
Acute suicidality
Mental disorder due to a general medical condition
Meet the following DSM IV TR diagnoses:
psychotic, drug abuse, developmental disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26870.018.09 |