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Effectiveness of a Brief Intensive Trauma Treatment for adolescents with (subclinical) PTSD: a multi-center randomized controlled trial

Effectiveness of a Brief Intensive Trauma Treatment for adolescents with (subclinical) PTSD: a multi-center randomized controlled trial - Effect of a BITT for adolescents with (s)PTSD: a multi-center RCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51843
Enrollment
70
Registered
2022-04-06
Start date
2022-10-03
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder PTSD

Interventions

KIT is an outpatient, intensive, one-week individual trauma therapy program. KIT is based on well-established protocols, consisting of two 90-minutes trauma therapy sessions a day (trauma exposure i

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

Inclusion 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) - At least subthreshold PTSD criteria, conform the CAPS-CA DSM-5, i.e.: o fully meeting criterion A, F and G and at least one symptom of criteria B, C, D and E; o or fully meeting criterion A, F, G and at least the B, C, D or E symptom clusters; - A written informed consent must be provided by the adolescent and, for adolescents aged 12-15 years, all legal guardians.

Exclusion criteria

Exclusion criteria: - unable to speak and write Dutch; - estimated or determined mental retardation (IQ

Design outcomes

Primary

MeasureTime frame
All study parameters will be assessed by questionnaires and structured interviews by the research-psychologist, blinded to the group condition of participants. PTSD symptoms will be assessed by the Child and Adolescent Trauma Screening (In Dutch Kind en Jeugd Trauma Screener (KJTS)) and the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA). In the substudy there are the following primary outcome measures: (1) PTSD symptoms are measured daily using questions from the KJTS and (2) the Cultural Formulation Interview (CFI) is administered to adolescents and parents. The CAPS-CA and SDQ will also be administered in the context of regular care.

Secondary

MeasureTime frame
Depression symptoms, anxiety symptoms and anger will be measured with the PROMIS pediatric item bank v2.0 and the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 Junior, module: 3, 6 and 12 resp.). Quality of life will be measured with the EuroQol-5D Youth and proxy (EQ-5D-youth and /proxy). Cost-effectiveness will be measured with the Treatment Inventory of Costs in Psychiatric clients (TiC-PY/proxy) and the (EQ-5D-youth and /proxy). Risk-behavior and safety will be measured with a questionnaire developed by Hendriks et al. (2017).

Countries

Netherlands

Contacts

Public ContactMM Westerveld

Amsterdam UMC

m.m.westerveld@amsterdamumc.nl+31643300014

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)