Clinical trial NCT06143982: Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT
Official title: Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (Subclinical) PTSD: a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: PTSD
Trauma
Intensive treatment
BITT
Adolescents
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm, mutli-center, randomized controlled trial (RCT). Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the intervention group (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT). When allocated to the WLCG, participants receive BITT after a 3 months waiting period. 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.
Primary purpose: TREATMENT

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 (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 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.

Primary outcomes:
measure: Changes in Posttraumatic stress symptoms (CAPS-CA)
timeFrame: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Changes in Posttraumatic stress symptoms (KJTS)
timeFrame: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Secondary outcomes:
measure: Changes in Anger symptoms (PROMIS)
timeFrame: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Changes in Anger symptoms (SCID-5 Junior)
timeFrame: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Changes in Anxiety symptoms (PROMIS)
timeFrame: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Changes in Anxiety symptoms (SCID-5-Junior)
timeFrame: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Changes in Depression symptoms (PROMIS)
timeFrame: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Changes in Depression symptoms (SCID-5-Junior)
timeFrame: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Changes in Quality of life
timeFrame: Quality of life is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Changes in Risk-behavior and safety
timeFrame: Risk-behavior and safety is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Dropout rates
timeFrame: Dropout is measures at each day of the BITT week (in total 5 days).
measure: Cost-effectiveness
timeFrame: Cost-effectiveness is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
Other outcomes:
measure: Age (moderator)
timeFrame: Age is documented at pre-treatment (T0).
measure: Sex (moderator)
timeFrame: Sex is documented at pre-treatment (T0).
measure: Socioeconomic status (SES; moderator)
timeFrame: SES is documented at pre-treatment (T0).
measure: Type of trauma (moderator)
timeFrame: Type of trauma is measured at pre-treatment (T0).
measure: Number of traumatic events (moderator)
timeFrame: Number of traumatic events is measured at pre-treatment (T0).
measure: Comorbidity (anger symptoms; moderator)
timeFrame: Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Comorbidity (anxiety symptoms moderator)
timeFrame: Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Comorbidity (depression symptoms; moderator)
timeFrame: Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Parental PTSD (moderator)
timeFrame: Parental PTSD is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
measure: Treatment center (Participating centers: Levvel/Karakter/Mental Health Caribbean; moderator)
timeFrame: Treatment center (Levvel, Karakter, Mental Health Caribbean) is documented at pre-treatment (T0).
measure: Residency (urban/rural; moderator)
timeFrame: Residency is documented at pre-treatment (T0).
measure: Ethnicity
timeFrame: Ethnicity is documented at pre-treatment (T0).
Locations:
city: Kralendijk
country: Bonaire, Sint Eustatius and Saba
facility: Mental Health Caribbean
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC/Levvel
state: Noord-Holland
city: Almelo
country: Netherlands
facility: Karakter
state: Overijsel
Study officials:
affiliation: Amsterdam UMC, location AMC/Levvel
name: Ramón Lindauer, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: