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peer-reviewed article from the last 5 years that uses a randomized controlled trial study design. The subject of the study may be any topic professionally relevant or interesting to your practice. You may not select an article already posted by one of your colleagues for this Discussion. (Tip: When searching, you may use “randomized trial” as one of your search phrases.)
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(2023) 23:644
Knipschild et al. BMC Psychiatry
https://doi.org/10.1186/s12888-023-05073-4
BMC Psychiatry
STUDY PROTOCOL
Open Access
Treatment of multiple traumatized
adolescents by enhancing regulation skills
and reducing trauma related symptoms:
rationale, study design, and methods
of randomized controlled trial (the Mars‑study)
Rik Knipschild1*, Helen Klip1, Doenja van Leeuwaarden1, Mariken J. R. van Onna1, Ramon J. L. Lindauer2,3,
Wouter G. Staal1,4,5, Iva A. E. Bicanic6 and Ad de Jongh7,8,9,10,11
Abstract
Background There is ongoing debate regarding the treatment of severe and multiple traumatized children and adolescents with post-traumatic stress disorder (PTSD). Many clinicians favor a phase-based treatment approach (i.e.,
a stabilization phase prior to trauma-focused therapy) over immediate trauma-focused psychological treatment,
despite the lack of scientific evidence. Research on the effects of different treatment approaches is needed for children and adolescents with (symptoms of complex) PTSD resulting from repeated sexual and/or physical abuse
during childhood.
Objective This paper describes the rationale, study design, and methods of the MARS-study, a two-arm randomized
controlled trial (RCT) that aims to compare the results of phase-based treatment with those of immediate traumafocused treatment and determine whether immediate trauma-focused treatment is not worse than phase-based
treatment in reducing PTSD symptoms.
Methods Participants are individuals between 12 and 18 years who meet the diagnostic criteria for PTSD due
to repeated sexual abuse, physical abuse, or domestic violence during childhood. Participants will be blindly allocated
to either the phase-based or immediate trauma-focused treatment condition. In the phase-based treatment condition, participants receive 12 sessions of the Dutch version of Skill Training in Affective and Interpersonal Regulation
(STAIR-A), followed by 12 sessions of EMDR therapy. In the immediate trauma-focused condition, the participants
receive 12 sessions of EMDR therapy. The two groups are compared for several outcome variables before treatment,
mid-treatment (only in the phase-based treatment condition), after 12 trauma-focused treatment sessions (posttreatment), and six months post-treatment (follow-up). The main parameter is the presence and severity of PTSD
symptoms (Clinician-Administered PTSD Scale for Children and Adolescents, CAPS-CA). The secondary outcome variables are the severity of complex PTSD symptoms (Interpersonal Problems as measured by the Experiences in Close
*Correspondence:
Rik Knipschild
[email protected]
Full list of author information is available at the end of the article
© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
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Knipschild et al. BMC Psychiatry
(2023) 23:644
Page 2 of 12
Relationship-Revised, ECR-RC; Emotion Regulation as measured by the Difficulties in Emotion Regulation Scale,
DERS; Self Esteem as measured by the Rosenberg Self Esteem Scale, RSES), changes in anxiety and mood symptoms
(Revised Anxiety and Depression Scale; RCADS), changes in posttraumatic cognitions (Child Posttraumatic Cognitions
Inventory, CPTCI), changes in general psychopathology symptoms (Child Behavior Checklist, CBCL), and Quality of Life
(Youth Outcome Questionnaire, Y-OQ-30). Furthermore, parental stress (Opvoedingsvragenlijst, OBVL) and patienttherapist relationship (Feedback Informed Treatment, FIT) will be measured, whereas PTSD symptoms will be monitored in each session during both treatment conditions (Children’s Revised Impact of Event Scale, CRIES-13).
Discussion Treating (symptoms of complex) PTSD in children and adolescents with a history of repeated sexual
and/or physical abuse during childhood is of great importance. However, there is a lack of consensus among trauma
experts regarding the optimal treatment approach. The results of the current study may have important implications for selecting effective treatment options for clinicians working with children and adolescents who experience
the effects of exposure to multiple interpersonal traumatic events during childhood.
Trial registrations The study was registered on the “National Trial Register (NTR)” with the number NTR7024.
This registry was obtained from the International Clinical Trial Registry Platform (ICTRP) and can be accessed
through the ICTRP Search Portal (https://trialsearch.who.int/).
Keywords Trauma, PTSD, Complex PTSD, Adolescents, EMDR, STAIR, TRAP, Stabilization, Phase-based treatment
Background
A meta-analysis of children and adolescents exposed
to traumatic events indicated that 16% developed posttraumatic stress disorder (PTSD) [1]. Adolescents with
PTSD re-experience traumatic events, avoid memories
of the trauma, develop negative thoughts and moods,
and are hypervigilant about potential threats [2]. Adolescents who have been exposed to (repeated) sexual
abuse, maltreatment, and/or domestic violence are at
an even higher risk of developing PTSD symptoms [1].
Beyond the core symptoms of PTSD, adolescents are
prone to developing a range of additional challenges,
including poor self-esteem, difficulties in interpersonal
relationships, and struggles with emotion regulation.
Collectively, these symptoms are commonly referred to
as characteristics of the ICD-11 classification Complex
PTSD [3, 4].
Although unprocessed trauma can significantly
impact a child’s development, several studies have demonstrated the effectiveness of trauma-focused treatments, such as eye movement desensitization and
reprocessing (EMDR) therapy, trauma-focused cognitive behavioral therapy (TF-CBT), and Prolonged Exposure [5, 6], in treating childhood PTSD. As a result,
trauma-focused treatments are generally recommended
in national guidelines for children and adolescents [7]
and international guidelines from reputable organizations, such as the International Society for Traumatic
Stress Studies [8] and the National Institute for Health
and Clinical Excellence [9]. However, it is worth noting
that most studies underlying these guidelines have primarily focused on children and adolescents who developed PTSD due to a single traumatic event, leaving a
knowledge gap regarding the efficacy of trauma-focused
therapies for children and adolescents with Complex
PTSD and a lack of consensus on the preferred treatment approaches for this population.
A position paper by the International Society of Traumatic Stress Studies [10] highlighted the insufficient
evidence available to support a specific treatment for
Complex PTSD in children and adolescents. This dearth
of evidence has sparked long-standing debate among clinicians and researchers regarding the optimal approach
for treating Complex PTSD. Recognizing the potential
limitations of existing evidence-based treatments for
children and adolescents with Complex PTSD and severe
clinical presentations, the ISTSS argues that modifications to trauma-focused treatments may be necessary to
address the symptoms of Complex PTSD effectively [10].
Consequently, various phase-based treatment models
have been developed for children and adolescents with
Complex PTSD [11, 12]. These models generally prioritize the enhancement of emotional and interpersonal
regulation skills as well as strengthening self-esteem
before embarking on trauma-focused treatment. However, it is important to note that a comprehensive body
of compelling evidence supporting the efficacy of phasebased models for the treatment of Complex PTSD is lacking [13]. Critics of phase-based models state that research
on adults with Complex PTSD has shown that the incorporation of regulation skills training prior to traumafocused therapy unnecessarily prolongs therapy [14–16].
In addition, studies using trauma-focused treatment in
adolescents have demonstrated promising results in the
treatment of PTSD and Complex PTSD with a history of
(repeated) sexual abuse and maltreatment [17–20], albeit
Knipschild et al. BMC Psychiatry
(2023) 23:644
with inconsistent findings and variations in the adaptation of treatment models.
Hence, the limited number of studies investigating
the effectiveness of treatments for young individuals
with Complex PTSD underscores the need for further
research [10]. In their position paper published in 2019,
the ISTSS deemed treatment recommendations premature because of current knowledge gaps. This indicates
a pressing requirement for research exploring the effects
of trauma-focused treatment on adolescents with (symptoms of complex) PTSD resulting from (repeated) sexual abuse, maltreatment, and/or domestic violence. To
address this research gap, the present study describes an
RCT aimed at investigating the differences in treatment
effects between two treatment approaches (i.e., phasebased versus immediate trauma-focused) in adolescents
with (symptoms of complex) PTSD resulting from a history of repeated sexual and/or physical abuse during
childhood.
The primary objective of this study is to compare the
results of phase-based treatment with those of immediate trauma-focused (i.e., eye movement desensitization
and reprocessing; EMDR) therapy using a two-arm randomized controlled trial design. The first aim is to determine whether immediate trauma-focused treatment is
not worse than phase-based treatment in reducing PTSD
symptoms. If trauma-focused treatment is found to be
equally effective when applied, it could lead to significant reductions in treatment duration. Second, we aim
to investigate whether the phase-based therapy approach
yields superior outcomes compared to the direct traumafocused condition in terms of Complex PTSD symptoms,
including emotion regulation, interpersonal problems,
and self-esteem. Additionally, we will examine comorbid symptoms and dropout rates as secondary outcome
measures. The third objective of the current study is to
identify potential moderators and predictors of dropout
or treatment responses/non-responses under both treatment conditions. We hypothesize that the presence of
affect dysregulation and interpersonal problems at the
beginning of therapy will be associated with poorer outcomes in the direct trauma-focused condition. Finally,
we will examine the relationship between the reduction
of posttraumatic stress symptoms in adolescents and a
decrease in self-reported parental/caretaker stress. This
objective addresses the clinical assumption that managing parental stress should be prioritized before initiating
PTSD treatment in adolescents.
Method
Study design
This study entails a single-blind, randomized controlled trial with two arms: a phase-based treatment
Page 3 of 12
condition (TRAP followed by EMDR) and a traumafocused treatment condition (EMDR only). In the
TRAP-EMDR condition, participants receive 12 sessions of skills training (TRAP; the Dutch adolescents
version of the STAIRS protocol), followed by 12 sessions of EMDR therapy. In the other condition, the participants receive 12 EMDR sessions. The two groups
will be compared for several outcome variables before
treatment, immediately after 12 sessions (post-treatment), and six months post-treatment (follow-up) (see
Fig. 1). This study will be coordinated by the Karakter
Academic Center for Child and Adolescent Psychiatry
in the Netherlands. The study started in 2018, paused
for seven months in 2020 due to COVID-19, and continued in September 2020. This study is ongoing and is
expected to be completed by 2024.
Participants
Participants are individuals between 12 and 18 years
of age, meeting the criteria for PTSD (according to the
Diagnostic and Statistical Manual of Mental Disorders,
fifth edition), and victims of repeated sexual and/or
physical abuse and/or domestic violence in childhood.
Participants are recruited from different departments
of Karakter, a large mental health organization for children and adolescents in the Netherlands. This applies
the following inclusion criteria: (1) meeting the criteria for PTSD, assessed with the Clinical-Administered
PTSD Scale for Children and Adolescents (CAPS-CA);
(2) reporting a history of (repeated) physical and/or sexual abuse and/or domestic violence by a caretaker, family member, or person in authority; (3) the availability of
a non-offending adult caregiver for the treatment, as the
presence of a caregiver is part of the treatment design;
(4) motivation and ability of the participant and the caregiver to attend weekly treatment sessions; (5) safe living
circumstances to minimize the risk of retraumatization
during the study; and (6) participants and caregivers have
sufficient command of the Dutch language to participate
in the treatment.
Exclusion criteria are (1) acute suicidal behavior or suicidal ideations requiring immediate hospitalization; (2)
severe head trauma indicated by a score < 9 on the Glasgow Coma Scale as known from the participant’s medical
history, to avoid brain dysfunction or retrograde amnesia of the traumatic event due to head injury; (3) concurrent psychotherapy during the study; (4) current severe
mental disorder in the participant’s main caregiver (as
evaluated by the responsible clinician), such as psychosis,
severe episode of depression, or severe substance abuse,
to assure the ability of the caregiver to participate in the
treatment; (5) a sibling of the participant already participating in the study (to avoid the transference of treatment
Knipschild et al. BMC Psychiatry
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Page 4 of 12
Fig. 1 Flowchart of the MARS-study
effects if siblings are randomized in different conditions);
and (6) intellectual disabilities (IQ < 70).
Randomization
Once the informed consent form is signed and the baseline questionnaires (T0 and T1) are completed, the randomization procedure begins. Participants are randomly
assigned to either a control or an experimental group
with a 1:1 allocation according to a computer-generated
randomization schedule stratified by sex (male or female)
and psychiatric diagnoses and using permuted blocks
of random sizes. The block sizes will not be disclosed
to ensure concealment. Participants will be randomized
using randomization.com, an online randomization tool.
Allocation concealment will be ensured because the
person who performs randomization has no other role
in the study. This person will prepare the randomization
lists and seal the envelopes. The randomization code will
not be released until the participant is recruited into the
trial, which occurs after all baseline measurements have
been completed.
To ensure allocation concealment, the steps involved in
randomization, outcome measurements, and treatment
are separated. Participants who meet the inclusion criteria and provide consent for participation will be randomized. Research assistants responsible for recruitment
and outcome measurement will request randomization.
Knipschild et al. BMC Psychiatry
(2023) 23:644
Procedures
The recruitment of participants began in 2018 at Karakter, with a break in 2020 due to COVID-19. The recruitment is ongoing and is expected to be completed by 2024.
All adolescents referred to Karakter sent a brief screening questionnaire called the Child Trauma Screening
Questionnaire (CTSQ) [21]. This self-report questionnaire asks about traumatic life events, such as domestic
violence, sexual abuse, or physical abuse. The research
team screens the results from the CTSQ. If multiple traumatic life events are reported and the adolescent shows
elevated scores on questions related to post-traumatic
stress, the involved healthcare provider is contacted.
The healthcare provider is informed about the MARS
study and asked to consider participation in the study.
The inclusion and exclusion criteria are verified by the
medical staff involved with the participants. With the
agreement of the healthcare provider and parents/legal
guardians, the adolescent is invited to participate in a
clinical structured interview (CAPS-CA).
After the CAPS-CA interview, the diagnostic results
are discussed with the research team and treatment team
of the MARS-study. A conclusion is drawn regarding
whether the inclusion criteria for PTSD due to multiple
interpersonal traumas are met. An advisory consultation will be scheduled with the participants and parents/
guardians if the inclusion criteria are met. During this
consultation, the participant is informed about their
participation in the treatment study, informed consent
is reviewed, and an information sheet about the study is
provided. After the advisory consultation, the adolescents
and parents/guardians have two weeks to decide whether
to participate in the study. If the adolescents and their
parents/guardians agree to participate, the randomization procedure is initiated, and a treatment provider is
assigned within three weeks. The MARS-study requires
written informed consent from both parents and adolescents. In addition, general practitioners are informed
through postal letters.
Interventions
Skills training in affective and interpersonal regulation
(TRAP; dutch version of STAIR‑A)
In Phase I of the phase-based treatment, we use an
adapted version of the Skills Training in Affective and
Interpersonal Regulation for Adolescents [12]. The purpose of this treatment is to address problems with affect
and interpersonal regulation (as they negatively impact
daily life) and to effectively utilize trauma-focused treatment. The program consists of twelve sessions, with different topics (e.g., distress tolerance, different kinds of
role-plays, labelling and identifying feelings, enhancing adequate coping strategies, training self-soothing
Page 5 of 12
skills, etc.). All TRAP sessions have an identical format
and structure: psycho-education about the rationale and
goals of interventions, skills acquisition, skills application, and practice.
EMDR therapy
The protocol for EMDR therapy is an evidence-based
trauma treatment aimed at resolving symptoms resulting from disturbing or unprocessed life experiences [22].
Treatment starts with recalling the traumatic memory and
selecting the most disturbing part of this memory with
associated dysfunctional thoughts and feelings. While
concentrating on the traumatic memory, the participant’s
working memory is taxed by employing eye movements for
approximately 30 s. Repeatedly, the participant is asked to
report what comes to mind, which may be cognitive, emotional, somatic, or imagistic experiences. After some sets of
eye movements, the participant is asked to report a Subjective Unit of Disturbances (SUD) between 0 and 10, until
the disturbance related to the memory reaches an SUD of
zero and positive beliefs are rated strong on a VoC (Validity of Cognition, between 1 and 7). A wide array of studies
support the working memory account as a mechanism that
explains treatment effects. Recalling a traumatic episode
depends on limited working memory resources. If a second
task, taxing working memory, is executed during the recall
of traumatic memory, fewer resources will be available to
recall the traumatic episode. By performing both tasks
simultaneously, the memory becomes less vivid and emotional and is stored in this new way. Consequently, negative
cognitions lose credibility, and positive cognitions become
more credible [23].
Measurements
The study parameters are listed in Table 1. In order to collect data to answer the research questions, it will take the
adolescent each time (T1, (T2), T3, T4) about 90–120 min
to complete the interview and questionnaires. The total
estimated burden for parents/legal guardians to complete
the questionnaires will be approximately 120 min. Participants allocated to the TRAP + EMDR condition will
undergo a mid-treatment assessment (T2) to investigate
the effect of TRAP on both the primary and secondary
outcomes.
Screening for traumatic experiences
The child trauma screening questionnaire
The Child Trauma Screening Questionnaire (CTSQ) [21]
is a self-reported measure that contains a 14 items list
of traumatic life events and a 10 items list to index posttraumatic stress symptoms of re-experiencing and hyperarousal. Each life event can be answered with yes (scored as
1) or no (scored as 0). Scores > 4 indicate positive screening
Knipschild et al. BMC Psychiatry
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Table 1 Study parameters
Instrument
Informant
Nr. Items
TRAP + EMDR
T0
Screening
CTSQ
Adolescent
24 items
T1
T2
EMDR only
T3
ES
x
T0
T1
T2
T3
ES
x
Baseline
Demographic variables
Intake Questionnaire
Medical files
Dissociative Experiences
A-DES
Adolescent
30 items
CAPS-CA
Adolescent
interview
x
x
x
x
Primary outcome
PTSD-assessment
x
x
x
x
x
x
x
Secondary outcome
Interpersonal problems
ECR-RC-mother
Adolescent
12 items
x
x
x
x
x
x
x
Interpersonal problems
ECR-RC-father
Adolescent
12 items
x
x
x
x
x
x
x
Emotion regulation
DERS
Adolescent
x
x
x
x
x
x
x
Self Esteem
RSES
Adolescent
10 items
x
x
x
x
x
x
x
Anxiety and Mood
RCADS
Adolescent
47 items
x
x
x
x
x
x
x
Posttraumatic cognitions
CPTCI
Adolescent
25 items
x
x
x
x
x
x
x
Behavior problems
CBCL
Medical files
113 items
x
Behavior problems
Y-OQ-30
Parent
30 items
x
x
x
x
x
Parental Stress
OBVL
Parent
34 items
x
x
x
x
x
x
Monitoring PTSD
CRIES-13
Adolescent
13 items
x
x
Patient-therapist relationship
SRS/ORS
Adolescent
8 items
x
x
Other measurements
Adherence
Medical files
T0 screening, T1 baseline, T2 Mid treatment, T3 post-treatment, T4 6-month follow-up, ES each session
for trauma symptoms. The CTSQ has been shown to have
good convergent validity [21]. Internal consistency was
reported, with a Cronbach’s alpha of 0.69.
Primary outcome
The clinician‑administered ptsd scale for children
and adolescents
The Clinician-Administered PTSD Scale for Children
and Adolescents (CAPS-CA) [24] is a structured clinical
interview used to establish the diagnostic status of the
DSM-IV and DSM-V criteria for PTSD. The interviewer
can rate the frequency and intensity of each symptom
on a five-point Likert scale. Furthermore, each symptom
can be rated as present or absent, as proposed by Weathers, Ruscio, and Keane [25] to score a symptom as being
present. The CAPS-CA can be reliably administered by
different interviewers. The Dutch CAPS-CA showed as
good internal consistency, inter-rater reliability, convergent and divergent validity, and concurrent validity
as the original English version [26]. The CAPS-CA will
be administered three times (T1, T3, and T4) for adolescents in the EMDR-only group and four times in the
TRAP + EMDR group (T1, T2, T3, and T4). Adding the
CAPS-CA at T2 in the TRAP + EMDR condition will
provide information about the effects and necessity of
skills training TRAP as a standalone treatment.
Baseline
The adolescent dissociative experience scale
The Adolescent Dissociative Experiences Scale (A-DES)
[27] is a self-report scale used to measure the frequency
of dissociative experiences among adolescents. The
answers to the 30 items are marked on an 11-point scale
ranging from 0 (never) to 10 (always). The total A-DES
score is the mean of all item scores (range, 0–10). A mean
score of 4.0 (Armstrong et al., 1997) is a commonly used
cut-off for pathological dissociation. The A-DES has four
theoretically derived subscales: amnesia, depersonalization/derealization, absorption, imaginative involvement,
and passive influence. The A-DES has good internal consistency and test–retest stability and has proven to be
valid across different cultural settings. The A-DES will be
administered at T1.
Demographics
Demographic information of the participants will be collected from medical files and/or intake questionnaires.
The gathered information will consist of age, sex, family
structure, diagnoses of the child, school functioning, and
socioeconomic status (SES) of the family.
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Secondary outcomes
The experiences in close relationships scale‑revised child
version
The Experiences in Close Relationships Scale-Revised
Child version (ECR-RC) [28] is a self-report questionnaire on parent–child attachment that consists of 12
statements about the adolescents’ mother or father. Using
a scale from 1 (not at all) to 7 (very much), six items tap
into attachment anxiety (e.g., ‘I worry that my father/
mother does not really love me’), and six items tap into
attachment avoidance (e.g., ‘I prefer not to tell my father/
mother how I feel deep down’). The reliability and validity of the ECR-R–C have been demonstrated in several
independent samples. In terms of reliability, the ECRR–C showed high levels of internal consistency, and in
terms of validity, the ECR-R–C subscales correlated with
depressive symptoms, emotion regulation strategies, and
parenting dimensions [29, 30].
Page 7 of 12
six subscales). Items are rated on a 4-point Likert scale
ranging from 0 (“never”) to 3 (“always”). Additionally, the
Revised Child Anxiety and Depression Scale – Parent
Version (RCADS-P) similarly assesses parental reports
of youth symptoms of anxiety and depression across the
same six subscales.
Child post‑traumatic cognitions inventory
The Child Posttraumatic Cognitions Inventory (CPTC)
[35] is a self-report questionnaire that measures traumarelated cognition in children and adolescents. The questionnaire consists of 25 items that can be answered on a
four-point Likert scale (range from 1 (strongly disagree)
to 4 (strongly agree). The English version of the CPTCI
has been validated for children and adolescents aged
6–18 years. The Dutch CPTCI has good reliability and
validity [36], high internal consistency (Cronbach’s 0.86–
0.93), and good convergent validity.
Difficulties in emotion regulation scale
Child behavior checklist
Emotion dysregulation will be measured using the Difficulties in Emotion Regulation Scale (DERS) [31]. The
DERS is a 36-item self-report questionnaire that measures six domains of emotion regulation difficulties: nonacceptance of negative emotions, difficulties in engaging
in goal-directed behaviors, difficulties in accessing effective emotion regulation strategies, impulsivity, limited
emotional awareness, and limited emotional clarity.
The items were rated from 1 (almost never) to 5 (almost
always). Higher DERS scores indicate greater emotion
regulation difficulties. The DERS is a valid and reliable
instrument for assessing emotional dysregulation [31,
32].
The Dutch parent-report version of the Child Behavior
Checklist 6–18 years (CBCL) assesses a wide range of
children’s emotional and behavioral problems, aiming to
identify children at a high risk of psychiatric disorders.
The CBCL/6–18 comprises 120 items assessing behavioral and emotional problems. These items are answered on
a 3-point Likert-type scale (0 = not true, 1 = somewhat or
sometimes true, 2 = very true or often true) by parents.
The scores display eight problem scales: withdrawn (1),
somatic (2), anxious (3), social (4), thought (5), attention (6), rule-breaking (7), aggressive (8), and other problems. The sum of problem scales 1, 2, and 3 forms the
scale ‘internalizing behavior’; 7 and 8 form ‘externalizing
behavior.’ All subscales comprise the total problem scale.
Some items contribute to more than one problem scale.
The CBCL assesses a broad array of potential traumarelated symptoms, including those not captured by a
PTSD-specific measure. T-scores are computed from
raw scores; higher scores on the syndrome scale indicate
greater severity of problems. A T-score of 63 (90th percentile) demarcates the clinical range, indicating that the
child requires professional assistance. The CBCL/6–18
has well-established psychometric properties in clinical,
non-clinical, and cross-cultural populations [37].
Rosenberg self‑esteem scale
The Rosenberg Self-Esteem Scale (RSES) [33] will be used
to assess self-esteem. It is a widely used 10-item Likerttype scale that measures self-esteem. Items are answered
on a 4-point scale, from strongly agree to strongly disagree, measuring positive and negative feelings towards
the self. The Dutch version of the RSES is a one-dimensional scale with high internal consistency and congruent
validity, and a Cronbach’s alpha of 0.89 [33].
Revised child anxiety and depression scale
The Revised Child Anxiety and Depression Scale
(RCADS) is a 47-item youth self-report questionnaire
[34] with subscales including separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive–compulsive
disorder (OCD), and major depressive disorder (MDD).
It also yields a Total Anxiety Scale (sum of the five anxiety subscales) and a Total Internalizing Scale (sum of all
Youth outcome questionnaire
To assess the therapy outcome in terms of changes in
symptom level, we will use the Dutch translation of the
Youth Outcome Questionnaire [38]. The Y-OQ-30 has 30
items and can be completed in 10–15 min on a 5-point
Likert scale with a range of 0 (never) to 4 (always). The
Y-OQ-30 has six subscales: Somatic complaints, Social
Isolation, Aggression, Behaviour problems, Hyperactivity,
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and Depression/ Anxiety. The Y-OQ-30 is a valid and
reliable test for assessing changes [39].
Parental stress questionnaire
The OBVL (“Opvoedingsvragenlijst”) is a 34-item parent
report questionnaire that measures experienced parental
stress [40]. The questions are answered on a 4-point scale
(1 = does not apply, 2 = applies a little, 3 = applies fairly,
and 4 = applies completely). Scores on the subscale of
problems in the parent–child relationship range from 6
to 24, where a score of 14 or higher indicates severe problems, for which treatment is indicated. Scores on ‘parenting problems’ range from 7 to 28, with a score of 18 or
higher indicating severe problems [41]. The OBVL demonstrated good reliability and validity.
Other measurements
Children’s revised impact of event scale
The Children’s Revised Impact of Event Scale (CRIES-13)
[42] is a brief self-report questionnaire designed to screen
for PTSD in children aged 8 years and older. It consists of 13 questions assessing posttraumatic intrusions,
avoidance, and arousal. Children rated the frequency
with which they had experienced each item during the
past week using a four-point Likert scale (0 = not at all,
1 = rarely, 3 = sometimes, 5 = often). Psychometric properties have been previously reported [42], showing that
the CRIES-13 is a valid measure of posttraumatic stress.
In this study, the internal consistency of the CRIES13 was 0.89. In this study, the CRIES-13 will be used to
measure posttraumatic stress symptoms between each
session during the course of treatment.
Outcome rating scale and session rating scale
To collect client feedback, we will use two brief questionnaires, the Outcome Rating Scale (ORS) and Session
Rating Scale (SRS), which can be easily administered on
a regular basis during treatment [43]. This allows treatment sessions to be evaluated at any time to ascertain
whether individual treatments are ‘on the right track’ to
a successful outcome. The ORS is primarily focused on
the client’s well-being and is administered at the beginning of the treatment session. The SRS is administered
at the end of the session and deals with how the client
experienced the treatment session. The outcomes of the
questionnaires are reflected in a graph per interview to
allow the height of the score and progress to be visualized
during the sessions.
Sample size and power
This study implemented a non-inferiority trial. A noninferiority trial is a type of clinical research study that
aims to demonstrate that a (new) treatment is not worse
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than an existing treatment by a prespecified margin.
Because the non-inferiority
