The study aims to answer the following research questions:1. How high/low are levels of symptomatology of depression and/or PTSD in traumatised refugee children in ASC?2. Do symptom levels decrease after a short-term trauma-focused intervention?3.…
ID
Bron
Verkorte titel
Aandoening
- Angststoornissen en -symptomen
- Levensstijlaangelegenheden
Synoniemen aandoening
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Key variables of this study are:
1. Posttraumatic stress symptoms (disorder)
2. Quality of life
3. General non-trauma specific stress reactions (such as bedwetting, eating
problems)
4. Behavioral and emotional symptoms
Secundaire uitkomstmaten
Drop-out, number of sessions, number of weeks, duration of intervention,
anxiety in parent(s).
Achtergrond van het onderzoek
Traumatized refugee children present a complex constellation of symptoms. Many
of them have been exposed to multiple stressful experiences, such as violence,
separation and migration, and are facing difficult living circumstances. Few
efficacy studies of treatments to this vulnerable group of children are
available (Henley & Robinson, 2011). The evidence for the use of the
psychotherapeutic intervention method EMDR in refugee children is still in its
infancy (Oras, De Ezpeleta & Ahmad, 2004) and limited when it comes to KIDNET
(Onyut, et al., 2005; Catani et al., 2009; Ruf et al., 2010). On the basis of
meta-analytic results, it is recommended to further explore trauma focused
interventions* incremental efficacy for refugee children in controlled studies
(Rodenburg et al., 2009). This project is a collaborative effort to study the
effects of EMDR and KIDNET as trauma-focused interventions for refugee children
in a RCT. Its significance is related to the limited knowledge that exists in
this field, with the theoretical gain that is expected, and with the relevance
because of a large and growing number of children in comparable circumstances
worldwide.
This study combines expertise in applying EMDR and KIDNET, in children
(Rodenburgh et al., 2009; De Roos et al., 2011; Neuner et al., 2008; Onyut et
al., 2005; Wanders et al., 2008) with expertise in working with this vulnerable
group. Effective interventions for mental health problems related to exposure
to traumatic events in children is lagging behind in comparison to adults.
Additionally, it is known that children may be burdened by psycho-traumatic
symptoms and hampered in their development (Van Ee, Kleber & Mooren, 2012).
Children of refugees and asylum-seekers offer an extra challenge for mental
health services. While violence and loss have frequently disrupted their lives,
they are also subjected to changing social surroundings due to flight, frequent
allocations and an uncertain future. At the same time, they have caregivers
undergoing similar levels or higher levels of stress causing various mental
health problems, which are thought to intertwine with mental health problems of
the child through limited parental availability and their rearing practices.
Complex posttraumatic disturbances may follow cumulative and chronic disrupting
life-events, such as war and subsequent migration and consist of severe chronic
symptoms as well as changes within the personality (Herman, 1993). The impact
on further development, including their ability to integrate, can be dramatic.
Therefore, it is important to offer interventions timely, efficiently and
effectively. Long-term consequences need to be prevented. This study aims at
optimizing their chances for recovery.
The theoretical questions that will be answered in this project are related to
the importance of traumatic memories and intrusions in children with more
complex symptoms of PTSD following traumatic experiences. Is trauma-focused
therapy (EMDR versus KIDNET) effective in alleviating and reducing PTSD? Is
this true for different age-groups: 6-8 and 12-18 years? Which factors are
predictive for treatment outcomes? Outcomes of this project will help us
understand how traumatic stress symptoms can be reduced in a high-risk group of
children. This project is a step towards disentangling these issues.
Lastly, the children included in this study are currently living in asylum
centers and awaiting the decision on their asylum application. A growing number
of refugees live in Western Countries, often in uncertainty of their future for
longer periods of time. This study can contribute to the discussion in the
mental health field if trauma focused therapy can be offered to this group as
they experience this uncertainty and live in non-optimal circumstances.
Ultimately, this study can open doors for a large group of children in need,
too often *unseen* in mental health institutions because of the lack of
understanding what trauma therapy can safely offer them in this period of their
lives.
Doel van het onderzoek
The study aims to answer the following research questions:
1. How high/low are levels of symptomatology of depression and/or PTSD in
traumatised refugee children in ASC?
2. Do symptom levels decrease after a short-term trauma-focused intervention?
3. Are EMDR and/or KIDNET effective in decreasing symptoms at the end of
treatment and/or follow-up?
4. Are EMDR and/or KIDNET effective in improving quality of life at the end of
treatment and/or follow-up?
The benefits of this project are several and related to implementation of
trauma-focused methods, examining systematically effects
of these types of interventions in high-risk groups and lastly dissemination of
knowledge and expertise (by publication and
presentation). This project will result in:
* starting clinical research expertise in the field of treatment of traumatized
refugee children.
* disseminating of findings to scientific and clinical professionals (through
publications, presentations).
* examining the merits of care as usual for this population and registration of
specific type of interventions.
Onderzoeksopzet
The design of the study is a randomized controlled trial using standardized
questionnaires as well as structured interviews and
performance data (quality of life); children between 8 and 18 years of age will
be randomly assigned to either EMDR, KIDNET or waitlist
control (N=30-30-30). They will be stratified in order to obtain two equal
sub-age-groups (8-12; 13-18 years). Sample size has been
based on power calculations incorporating small to moderate effect sizes and
risk of drop-out (software G*power (Faul, Erdfelder,
Lang, Buchner, 2007).
Children will be assessed at intake (before first treatment session), after the
last session (maximum of 8 sessions of 1 hour) and at
follow-up (3 months after the last session). Moreover, participants will fill
out the CRIES (Children*s Revised Impact of Event Scale)
each session to monitor changes closely. In the period between the last
treatment session and follow-up no prolonged treatment
will be offered, unless really needed. The EMDR therapy will be performed by
therapists who are trained at EMDR level-ll and in providing KIDNET. They will
receive monthly supervision by a registered supervisor. Treatment fidelity will
be checked to assess treatment adherence in both conditions.
Onderzoeksproduct en/of interventie
Participants of the study will be informed about the study and then randomly assigned to one of two interventions versus a (temporarily) wait-list condition: 1. Eye Movement Desensitization Reprocessing (EMDR), 2. Narrative Exposure Therapy (KIDNET), versus 3. Waiting list. Interventions Both research conditions will consist of 8 weekly sessions. The EMDR treatment condition starts with one preparatory session to establish a working alliance, conduct a case conceptualisation and to obtain agreement on treatment targets. (1) EMDR The trauma-focused EMDR condition continues with 7 sessions aimed at reducing disturbance associated with the most distressing traumatic memories, following the Dutch version of the EMDR protocol for children and adolescents (de Roos, Beer, De Jongh & ten Broeke; based on De Jongh & Ten Broeke, 2003; Shapiro, 2001). EMDR sessions last 75 minutes. (3) KIDNET The trauma-focused KIDNET condition continues with 7 sessions aimed at reducing disturbance associated with the most distressing traumatic memories, in chronological order (Neuner et al., 2008; Schauer et al., 2017). Kidney sessions last 75 minutes (same amount as EMDR). (3) Waiting list control condition (WL) Once trauma-focused treatment has been indicated, a child may be assigned to the waiting list. This implies that a child will have to wait 8 weeks before the start of EMDR or KIDNET (second randomization). Parental guidance In all conditions parent guidance will be offered > with a maximum of 4 sessions 1 hour, commonly with interpreter). There is consensus in the clinical field that parent guidance in the treatment of refugee children is needed. Psychoeducation is the dominant subject of the encounters with parents (e.g., information about the interventions; what kind of reactions can be expected in their children). The interventions (in terms of duration, kind and frequency) that parents receive will be registered. In the treatment of children there is great reluctance to prescribe medication; during this study it is therefore not to be expected that any medication will be needed as extra intervention. In the case of a crisis, a child-psychiatrist is available to be consulted > as is a normal procedure during treatment. Extra interventions will be noted (in the rare occasion medication will be prescribed, the child will be excluded from the study).
Inschatting van belasting en risico
No particular risks are being foreseen for participants. Data will be handled
confidentially and stalled anonymously. A subject identification code will be
used to link the research data to the subject. The key to the code will be kept
separate by the investigator. The handling of personal data will be according
to the Dutch Personal Data Protection Act (in Dutch: De Wet Bescherming
Persoonsgegevens, Wbp).
Children will be compensated for their participation with a coupon (euro 10)
per measurement after treatment (M2 and M3).
Publiek
Rijnzichtweg 35
Oegstgeest 2342 AX
NL
Wetenschappelijk
Rijnzichtweg 35
Oegstgeest 2342 AX
NL
Landen waar het onderzoek wordt uitgevoerd
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Zie D4a.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Zie D5a.
Opzet
Deelname
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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Register | ID |
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CCMO | NL40769.058.13 |
OMON | NL-OMON22679 |