The aim of the study is:1) To test the effectiveness and cost-effectiveness of KIT for adolescents with (s)PTSD and comorbid symptoms. 2) To compare the outcomes from the current study with outcomes we have collected in two previous randomized…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
The majority of children and adolescents experience one or more traumatic life
events while growing up. Up to one in five of these youngsters suffers from
posttraumatic stress disorder (PTSD) symptoms. An even larger group suffers
from subclinical (s)PTSD. (S)PTSD can cause extreme suffering and impairment in
functioning, comparable to full-blown PTSD. Moreover, (s)PTSD coincides with
high numbers of comorbid somatic and psychiatric illnesses and high-risk
behavior (self-harm and suicidality. Untreated (s)PTSD often maintains or
worsens comorbid psychopathology. (s)PTSD can be treated effectively in youth
through weekly sessions of eye movement desensitization and reprocessing (EMDR)
or trauma-focused cognitive behavioral therapy (TF-CBT). Despite availability
of these treatments, a large group does not receive EMDR or TF-CBT. This may be
because patients and clinicians do not recognize or underestimate the impact of
(s)PTSD. Also, clinicians seem hesitant to address trauma symptoms due to fear
of deterioration of present high-risk behavior. Moreover, current trauma
treatment trajectories take at least several months. This treatment delay
and/or prolonged treatment trajectories interfere with healthy development
(e.g. school dropout, reduced social contacts and/or hobbies) and lead to high
dropout rates in treatment. These findings underline the need for innovative
and brief trauma treatment strategies. A first pilot study has shown that Brief
Intensive Traumatreatment (in Dutch Korte Intensieve Traumabehandeling (KIT))
(BI-TFT ) can be a safe, effective treatment for youth with (s)PTSD. Based upon
these first positive experiences we have developed a one-week KIT-program for
adolescents.
Study objective
The aim of the study is:
1) To test the effectiveness and cost-effectiveness of KIT for adolescents with
(s)PTSD and comorbid symptoms.
2) To compare the outcomes from the current study with outcomes we have
collected in two previous randomized controlled trials (RCTs), comparing
regular (and thus prolonged) TF-CBT and EMDR in adolescents with (s)PTSD (n=70)
on effectiveness, cost-effectiveness, and drop-out rates.
3) To test the effectiveness of a KIT for Papiamento-speaking adolescents with
(s)PTSD and comorbid symptoms.
4) To describe cultural differences in PTSD between Papiamento-speaking
adolescents in the Dutch Caribbean and adolescents in the Netherlands.
Study design
The current study is a multi-center, single-blinded RCT which will be conducted
at the Amsterdam UMC. Adolescents (12-18 years old) with (s)PTSD will be
randomly allocated by an independent researcher to the KIT (n=50) versus a
waitlist control group (WLCG; n=50), stratified by age . Measurements are done
at comparable time intervals for both groups: at pre-treatment (T0), directly
after KIT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up. The
WLCG follows the KIT after the 3 months follow-up.
The sub study will be conducted using a single case experimental design (SCED).
The SCED will consist of multiple phases: phase A (baseline; 2 weeks), phase B
(BITT; 5 days); phase C (post-treatment follow-up; 9 days); phase D (3-month
follow-up; 9 days). Throughout the different phases, participants will complete
short daily assessments. In addition, participants will complete larger
assessments before phase A and after phase C.
Intervention
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 in the morning and EMDR in the
afternoon), two 60-minutes psychomotor therapy sessions a day, one 90-minutes
psychoeducation session for parents a day, and a 90-minutes family therapy
session at the end of the week (sharing the trauma narrative).
Study burden and risks
Currently, a large group of adolescents with (s)PTSD does not receive adequate
treatment. Participation in this study provides an extras treatment
opportunity. Furthermore, current trauma treatment takes at least several
months. The current study intends to significantly reduce the burden on
adolescents and their parents by offering effective treatment in a short period
of time. The risks associated with the current study are comparable to those
of standard treatment and the burden is presumably less to regular therapy
considering its brief duration. To prevent extra risks, a so called *crisis
prevention plan* will be developed together with all participants (and their
caregiver(s)) before the treatment (KIT or WLCG) phase. This is in line with
regular care for youngsters vulnerable to crisis and high-risk behaviour. A
first pilot study has shown that brief intensive trauma treatment can be a
safe, effective treatment for adolescents with (s)PTSD. Assessments are,
overall, comparable to those in regular care thus form no extra burden.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
- unable 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.
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL81121.018.22 |