Intensive trauma treatment for adolescents with PTSD

Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (Subclinical) PTSD: a Multi-center Randomized Controlled Trial

This study is testing a new short-term treatment for teenagers aged 12-18 with mild PTSD symptoms to see if it helps them feel better after experiencing trauma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 3 sites (Kralendijk and 2 other locations)
• Trial ID: NCT06143982 on ClinicalTrials.gov

What this trial studies

This study examines the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents aged 12-18 who have experienced psychological trauma and meet criteria for subthreshold PTSD. It is a multi-center, single-blinded randomized controlled trial where participants are allocated to either the BITT group or a waitlist control group. Assessments will be conducted at multiple time points: before treatment, immediately after treatment, and at 3, 6, and 9 months follow-up. The waitlist control group will receive the BITT after the initial follow-up period.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 12-18 with a history of psychological trauma and at least subthreshold PTSD symptoms.

Not a fit: Patients who do not speak or write Dutch or have ongoing severe mental health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the mental health outcomes for adolescents suffering from PTSD.

How similar studies have performed: Other studies have shown promise with intensive trauma treatments, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Kralendijk and 2 other locations

• Mental Health Caribbean — Kralendijk, Bonaire, Sint Eustatius and Saba (RECRUITING)
• Amsterdam UMC, location AMC/Levvel — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
• Karakter — Almelo, Overijsel, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Ramón Lindauer, Prof. dr. — Amsterdam UMC, location AMC/Levvel
• Study coordinator: Myrna Westerveld, MSc

Conditions: Post-traumatic Stress Disorder, PTSD, Trauma, Intensive treatment, BITT, Adolescents