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Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT

Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT

Recruiting
12-18 years
All
Phase N/A

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Overview

The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.

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 (WLCG; n=50), stratified by center. Measurements are done at comparable time intervals for both groups: at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up. The WLCG receives BITT after the 3 months follow-up.

Eligibility

Inclusion Criteria:

        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 Criteria:
        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.

Study details
    Post-traumatic Stress Disorder

NCT06143982

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

25 January 2024

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