The STAP-study: Skills training and traumafocused treatment in multiple interpersonal traumatized adolescents with PTSD.

Epidemiological research shows that 34 out of 1000 Dutch children are victims
of child abuse (Alink et al., 2012). This number implies that annually more
than 100.000 children deal with chronic stress due to domestic violence,
physical abuse, emotional neglect and/or sexual abuse. As a result, these
children face an increased risk of developing medical problems later in life
such as obesitas, diabetes, cardiovascular problems, sexually transmitted
diseases, and COPD (Dube et al., 2003). They also more often face psychiatric
problems such as mood and anxiety disorders, psychosis, personality disorders,
posttraumatic stress-disorder (PTSD), somatic disorders, and developmental
disorders such as ADHD (Fergusson, McLeod & Horwood, 2013). In addition,
several studies show that children who are a victim of child abuse show a
higher rate of drop out at school (Porche et al., 2011). They also develop more
often problems with substance use abuse (Fergusson, McLeod & Horwood, 2013) and
face difficulties in participating in society. The distress that results from
child abuse is proven to be harmful for the child*s development, and therefore,
ending these situations and treating the impact of chronic trauma is pivotal.

Child abuse related PTSD is prevalent in youth utilizing inpatient and
outpatient mental health services (Mueser & Taub, 2008). As described, child
abuse is also associated with increased rates of major depression, anxiety
disorder, suicidal ideation, suicide attempts, alcohol dependence, and drug
dependence later in life (Fergusson, McLeod & Horwood, 2013). It has been found
that trauma-related problems are not identified and addressed well in early
adolescence; changing cognitive, behavioral and emotional patterns become
increasingly difficult later in life (Ford, 2009). Furthermore, the adverse
childhood experiences-studies (Felliti et al., 1998) found the higher the
Adverse Childhood Experiences (ACE) score, defined as the amount of ACE*s, the
greater the risk of experiencing poor physical and mental health, and negative
social consequences later in life. On top of this, child abuse victims are at
increased risk for revictimization (Benjet et al., 2015). Theory and research
suggest that PTSD may mediate the relationship between child abuse and later
interpersonal violence. Revictimization is one of the most troubling outcomes
associated with child abuse, because later victimization is likely to compound
or exacerbate the effects of prior abuse experiences (see Classen, Palesh, &
Aggarwal, 2005, for a review). To help break the cycle, PTSD should be treated
as early as possible with the most effective methods available.

Recent RCT*s show that both EMDR Therapy and Trauma-focused Cognitive
Behavioral Therapy (TF-CBT) are effective in the treatment of children and
adolescents with PTSD (Diehle et al., 2014). Both interventions are included in
the National Guidelines of Anxiety Disorders (Nationale Richtlijn
Angststoornissen, Balkom et al., 2013). Nevertheless, in practice, direct
trauma treatment with a primary focus on reducing PTSD symptoms, for child
abuse victims is indicated in a highly restrained order (Bicanic, de Roos,
Beer, & Struik, 2016) for various reasons such as fear of therapists to
possibly dysregulate their patients when exposing them to traumatic memories.
This has recently led to the development of several phase-based treatment
models. Meaning that patients are first taught to stabilize themselves through
skills training before focusing on reprocessing the trauma (Cloitre et al.,
2012; Gudino et al., 2014, Dorrepaal e.a., 2015) which is in line with several
international guidelines, such as the International Society for Traumatic
Stress Studies (2012) and the European Society for Trauma and Dissociation
(2015). However, convincing evidence for there is lacking (Bicanic et al.,
2015; De Jongh et al., 2016).

Stabilizing patients through skills training may have some disadvantages. For
example, this may entail an elevated risk that patients suffer longer than
necessary from symptoms that could have been treated effectively with a
traditional evidence-based trauma-focused therapy (see De Jongh et al., 2016).
Furthermore, if the first phase of the phase-based treatment protocol is indeed
redundant, incorporation of a skills training would unnecessarily lengthen
therapy, thereby increasing the likelihood of dropping-out, particularly if
this, in the patient*s view, no longer contributes to the intended treatment
results. In addition, patients may get the impression that the therapist is
unwilling or unable to listen to the patient*s story for fear of being exposed
to details of patients* traumatic memories, which may adversely affect the
therapeutic relationship and self-confidence of the patient.

Moreover, some assumptions in favor of phase-based trauma treatment do not
match with recent findings from research in adult trauma treatment. For
example, there is evidence to suggest that adults with abuse related PTSD in
combination with a psychotic disorder (van den Berg et al., 2015), a
personality disorder (Raabe et al., 2015) or dissociative symptoms (Van Minnen
et al., 2016) can be treated effectively and safely by trauma-focused
interventions without a preparatory period of skills training. These findings
resulted in a discussion about the validity of the international guidelines for
treating complex PTSD (see De Jongh et al., 2016).

With the urge to 1) break the cycle of revictimization in traumatized
adolescents and having knowledge that 2) intervening as early as possible will
prevent further damage to quality of life due to the effects of chronic stress
on somatic and psychological functioning and the predicted 3) difficulties of
changing cognitive, behavioral and emotional patterns later in life, the three
most important aspects to write the proposal are described. With these aspects
in mind the search for effective treatments to reduce posttraumatic stress
symptoms in adolescents with child abuse related PTSD (as early as possible)
makes sense. Therefore, the debate as to whether or not to offer adolescents a
12-session skills training before encountering trauma-focused treatment is
worthwhile researching.

In conclusion, there is a lack of knowledge concerning the safety and efficacy
of treatment for adolescents with PTSD as a result of child abuse. Therefore,
the aim of the proposed project is to compare a phase-based treatment (skills
training followed by trauma-focused therapy) with a trauma-focused therapy
(without prior skills training), to evaluate their relative effectiveness.

The randomized controlled trial (RCT) will be performed at Karakter Child and
Adolescent*s Psychiatric Hospital and will be implemented at all locations,
spread out over three provinces in The Netherlands. The project aims:
1. To explore the necessity and efficacy of a preparatory skills training in
the treatment of patients suffering from PTSD due to multiple interpersonal
traumatization. The main objective is to demonstrate that the new therapy
(EMDR-only) is non-inferior to the standard phase-based therapy (STAIR-EMDR)
based on the change of the Clinician-Administered PTSD Scale for Children and
Adolescents (CAPS-CA). If EMDR proves to be as effective as EMDR preceded by
STAIR-A, it opens the way to a significantly reduced treatment duration.
2. To investigate whether a phase-based treatment approach will lead to a
significantly better outcome than the direct trauma-focused condition in terms
of symptoms of Complex PTSD (emotion regulation, interpersonal problems and
self-esteem), comorbid symptoms and drop-out rate. An additional aim is to
investigate potential moderators and predictors of drop-out or treatment
(non-)response. To this end, we hypothesize that signs of affect dysregulation
and having interpersonal problems at the start of therapy will be related to
worse outcome in the direct traumafocused condition (e.g., Cloitre, Petkova,
Su, & Weiss, 2016; Dorrepaal et al., 2014).
3. To explorer gender differences related to treatment response. We know that
there are significant differences in the ways that female and male adolescents
think, act, and relate. Furthermore, treatment results may very well depend on
the gender of the patient. In all analyses, we will take a close look at the
results with regard to gender differences.
4. To investigate whether reduction of posttraumatic stress symptoms in the
adolescent is related to reduction in self-reported parental/caretaker stress,
since one common clinical assumption states that therapists should focus on
managing parental stress before starting PTSD treatment with adolescents.

This study entails a randomized controlled trial with two arms; a phase-based
treatment condition (STAIR followed by EMDR) versus a trauma-focused treatment
condition (EMDR only). In the STAIR-EMDR condition, patients receive 12
sessions of skills training (STAIR-A), followed by 12 sessions of EMDR therapy.
In the other condition, patients receive 12 sessions of EMDR therapy. All
sessions take 90 minutes and are provided by the same therapist for every
patient. The two groups will be compared on a number of outcome variables
before treatment, after six sessions, post-treatment and three months and six
months post-treatment (follow up).

Participants in condition 1 will receive 12 sessions of STAIR-A followed by 12
sessions EMDR. Participants in condition 2 will receive 12 sessions of EMDR.

The risks for children and parents are minimal, since both groups recieve
treatment as usual.
Regading the burden for patients: assessment of psychopathology is common in a
pretreatment phase. Measuring therapeutic effects after CBT/EMDR treatment is
also common. However, the burden in participating in this study is somewhat
more intensive due to multiple (and repeated) measurements, which aren't common
in clinical pratices.