Status:
RECRUITING
Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Post-traumatic Stress Disorder
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.
Detailed Description
This study is a multi-center, single-blinded RCT. Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the BITT (n=50) versus a waitlist control group ...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 12-18 years of age;
- with a history of psychological trauma (conform the Life Events Checklist of the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM-5) (Nader, 2004; van Meijel et al., 2019);
- at least subthreshold PTSD criteria, conform the CAPS-CA DSM-5, i.e.;
- fully meeting criterion A, F and G and at least one symptom of criteria B, C, D and E;
- or fully meeting criterion A, F, G and at least the B, C, D or E symptom clusters;
- and written informed consent must be provided by the adolescent and, for adolescents aged 12-15 years, all legal guardians.
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study in case of:
- inability to speak and write Dutch;
- estimated or determined mental retardation (IQ \<70);
- suffering from ongoing trauma by a parent who is part of the adolescent's current primary-care system.
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06143982
Start Date
October 5 2022
End Date
February 1 2026
Last Update
November 22 2023
Active Locations (3)
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1
Mental Health Caribbean
Kralendijk, Bonaire, Saint Eustatius and Saba
2
Amsterdam UMC, location AMC/Levvel
Amsterdam, North Holland, Netherlands, 1105 AZ
3
Karakter
Almelo, Overijsel, Netherlands, 7600 AP