Primary Objectives1. The primary objective of Study 1 is to evaluate the relationship of IPV and children*s symptoms and adjustment within a clinical sample of 75 families exposed to IPV and 50 comparison families, and to test whether this…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
emotionele en gedragsproblemen bij kinderen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To address the main study aim, the main parameters are the reductions in trauma
symptoms, internalizing and externalizing problems and improvements in
adjustment in children from baseline to post-test and 6-month follow-up. To
address our other study aims, the main parameters are observational, interview
and questionnaire measures of parental availability, parent-child relationship
variables, physiological assessment and children*s responses to IPV.
Secondary outcome
Not applicable
Background summary
Exposure to interparental violence (IPV) can be a traumatic experience for
children and is associated with poor developmental and adjustment outcomes.
Trauma focused-cognitive behavioral therapy (TF-CBT) has shown to be effective
for treating children*s psychological trauma in general, but appears to be less
effective for IPV. Given that IPV affects the whole family unit, a promising
direction is extending trauma-focused cognitive behavioral therapy with
components involving parents. Different ideas exist regarding the manner in
which parents can be effectively involved, and the mechanisms that explain the
effects of multi-component treatments. At present, it is unclear which
components can contribute to treatment effectiveness in TF-CBT based therapies
for children who have experienced IPV.
Study objective
Primary Objectives
1.
The primary objective of Study 1 is to evaluate the relationship of IPV and
children*s symptoms and adjustment within a clinical sample of 75 families
exposed to IPV and 50 comparison families, and to test whether this
relationship can be explained by the following factors
i) children*s emotional, cognitive, behavioral and physiological responses
ii) parental availability
iii) quality of the parent-child relationship and parenting
Research question 1:
A. Which factors mediate or moderate the effects of IPV on children*s symptoms
and adjustment and how are they inter-related?
Additionally, this study will compare children exposed to IPV and 50 matched
comparison families to identify differences in emotional, cognitive,
behavioral, and physiological functioning between these two groups.
B. Does the quality of the parent-child relationship, parental availability and
children*s emotional, cognitive, behavioral and physiological responses to
conflicts and violence differ between families who have been exposed to IPV vs.
those who have not been exposed?
Families in the comparison group will be matched with IPV-exposed families on
demographic variables, such as gender, SES, family structure and ethnicity.
2.
The primary objective of the Study 2 is to evaluate the effects of (i) the
parent preparatory program and (ii) the parent-child interaction component as
additions to the Horizon, a TF-CBT-based group therapy for parents and children
who have experienced IPV on child symptoms and adjustment.
Research question 2:
A. Is Horizon TF-CBT more effective when a 6 session preparatory program for
parents is offered?
B. Is Horizon TF-CBT more effective when a parent-child interaction component
is offered at the end of each therapy session?
C. Is Horizon TF-CBT more effective when both a preparatory program for parents
and a parent-child interaction component are offered?
Secondary objectives
A secondary goal within our RCT study (Study 2) is to investigate associated
changes between: 1) child symptoms and child adjustment, 2) child emotional,
behavioral, and cognitive responses, 3) parental availability and 4)
parent-child interaction.
Research question 3:
A. Are changes in child symptoms and adjustment after treatment associated with
changes in emotional, behavioral, and cognitive responses in children?
B. Are changes in child symptoms and adjustment after treatment associated with
changes in:
1. parental availability
2. parent-child interaction
C. Are changes in parental availability and parent-child interaction after
treatment associated with changes in children*s emotional, behavioral, and
cognitive responses?
Third, the goal is to examine whether the preparatory program and the
parent-child interaction component sessions achieved what they aimed to change
and whether these changes mediate child symptoms and adjustment, specifically:
Research question 4:
A. Does the preparatory program lead to increased parental availability, and
does this mediate reduction in symptoms and improvement in child adjustment
after treatment?
B. Does the parent-child interaction component lead to improved parenting
behavior to support the child, and does this mediate reduction in symptoms and
improvement in child adjustment after treatment?
C. If these changes in parental availability and improved parenting behavior
occur, the explorative question is whether these changes lead to a reduction in
symptoms and improvement in child adjustment after treatment by changing
emotional, behavioral and cognitive child responses.
Finally, we will control for variables that have been shown to potentially
affect the relations that are at the heart of our project: duration and
severity of the IPV (Kitzmann et al., 2003), parental psychopathology
(Levendosky et al., 2003) and new incidents of IPV.
Study design
There are two studies. Both studies use a multi-method approach combining both
observational and quantitative data collection within a cross-sectional design
(Study 1) and a randomized 2 by 2 factorial experimental design (Study 2). In
this multi center RCT study the workings of two parental compnents added to
TF-CBT will be tested. The resulting design is a 2 (preparatory program present
versus absent) x 2 (parent-child interaction present versus absent) factorial
randomized experimental design with a pre- and post-test and follow-up after
six months in which one-hundred children and their custodial parents will
participate.
Intervention
Horizon, a trauma-focused cognitive behavioral based therapy (TF-CBT)
consisting of 15 sessions of group therapy for children and a parallel
parenting program is offered to 100 children. In a factorial design, this group
will be randomly divided in 50 dyads with and 50 dyads without the preparatory
parent component (6 extra sessions) and in 50 dyads with and 50 dyads without
the parent-child interaction component.
The HORIZON 3 & 4 (Leeuwenburgh, Visser, & Lamers-Winkelman, 2006b; Visser et
al., 2006b) is a group intervention for children and their parent(s) for
children who have been exposed to IPV. The aim of the intervention is to help
children process the traumatic experiences of having been exposed to IPV. The
aim of the parent group is to guide parents to help their traumatized children
by processing the traumatic experiences and by adjusting to the IPV. Both
children and parents have a therapy book (Leeuwenburgh, Visser, &
Lamers-Winkelman, 2006a; Visser, Leeuwenburgh, & Lamers-Winkelman, 2006a). This
book is used weekly during the therapy sessions for information about the
topic, assignments, and drawings.
For the description of the intervention we distinguish three parts:
1. The Preparatory Program (PP) is for the parents and consists of six
sessions. The preparatory program aims to increase parental availability and
insightfulness in their children*s needs. Parents are coached to accurately
read the behavioral and emotional signals of their children*s needs and to
adequately respond to these signals. To enable them to do so, the therapists
coach parents to better differentiate between their own and their children*s
needs, to differentiate between their own violence history and the children*s
violence history, to differentiate between their own posttraumatic stress
responses and those of the children, to gain insight into the developmental
tasks appropriate to the age of the children, and to gain insight in the
developmental consequences of IPV on children.
2. The second part is the parallel parents and children groups and consists of
fifteen weekly sessions. Because the intervention is trauma-focused and based
on cognitive behavioral therapy principles, it includes the same components as
the TF-CBT that was described and studied by Cohen and Mannarino (2008).
Components of this intervention method are psycho-education, relaxation,
affective expression and modulation, cognitive coping and processing, trauma
narrative and parenting skills. These components are covered by the following
themes: psycho-education about therapy, violence and conflicts, and
posttraumatic stress; training of emotion regulation skills; addressing
incorrect attributions about conflict and violence; expressing and sharing the
IPV experiences; managing anger, guilt and shame handling nightmares; good and
bad sides of mother and father; and future safety. These weekly sessions have a
duration of 60 minutes.
3. The Parent Child Interaction Component (PCIC) takes place adjacent to the
parallel parent and child group. The parent group joins the children*s group
after one hour. During 30 minutes, parents and children are given the
opportunity to work on the way in which they interact with each other. The aim
of the PCIC for the parents is to learn to show more emotional supportive
behavior, more involvement (e.g., talking together), more praise, less harsh
discipline, and increased parental presence (e.g., time spent together). This
parenting behavior can be practiced and trained by the parents in exercises
during the parent-child interaction component. Parents will receive feedback on
their interaction behavior during the next session in the parallel parent
group. Children will receive feedback on their interaction behavior directly
during the session.
All children and parents in all four conditions will receive therapy as
described in part two of the above mentioned three components. This part of the
treatment was developed first by the authors. (The preparatory program and the
parent child interaction component were added later to the HORIZON therapy).
There is no waitlist or control intervention. After each session, the
therapists of both the parent program and the child program will evaluate the
session and share information about children*s as well as parent's progress.
Study burden and risks
The risk associated with our study is considered small. Our study focuses on
the effectiveness of parental components in the TF-CBT-based *Horizon* therapy
for children who have experienced IPV. TF-CBT is known to be effective in
reducing emotional and behavioural problems and PTSD symptoms in children who
have experienced trauma (Cohen et al., 2010; Cohen & Mannarino, 2008; Cohen,
Mannarino, & Murray, 2011). For more than 10 years, the TF-CBT-based group
therapy *Horizon* has been used to treat children who have experienced IPV. The
therapy is administered in several children and youth treatment centers in the
Netherlands and does not seem to involve risks for participants. The Horizon
therapy has the status 'theoretically sound' by the NJI
(http://www.nji.nl/eCache/DEF/1/22/611.html). The intervention will be
delivered by trained and supervised clinicians using a published treatment
manual (Leeuwenburg, Visser, & Lamers-Winkelman, 2006). Children and parents
who can participate in the current study are already referred to the respective
treatment centers (KJTC Haarlem, Fier Fryslan, De Rivierduinen) to participate
in the Horizon group therapy. For this study, the families will be randomly
assigned to one of four treatment conditions within this therapy. As a
consequence of the 2 by 2 factorial design, children and parents that
participate in the current study will always receive therapy. There are no
waitinglist or placebo control conditions. Further, previous research has not
provided evidence that the addition of a preparatory program or parent-child
interaction component makes TF-CBT more effective for children. Based on
theoretical considerations, we expect that the addition of the two components
could be beneficial for children, but our study has yet to confirm this
hypothesis. Given the potential deleterious outcomes of experiencing IPV for
children and their families and the scarcity of available treatments for this
group, the development and refinement of evidence-based therapies that address
IPV-related trauma is clearly warranted.
In addition to the therapy itself, we ask children and parents to fill out
questionnaires on three occasions and to participate in 2 observational tasks,
which will be combined with physiological assessments. There is also an
interview with the primary caregiver. The total assessment will take
approximately 2 hours and 45 minutes for parents and 2 hours for children at
T1. At T2 and T3 the assessment time will be around 1 hour. Observational tasks
simulate frequently occurring interactions between parent and children and were
not associated with burden for participants in previous research (Oppenheim et
al., 2007). The family interaction task has previously been approved for
research with children in youth mental health care (CCMO P04.0817c).
Physiological assessment using the VU-AMS has been used often with children
(Oosterman & Schuengel, 2007) and the assessment tools are non-invasive.
The potential burden of the participation in the research could be that
questionnaires probe into the children*s and parent*s experience of IPV.
However, the topic of IPV will also be addressed extensively in the therapy
itself. Questionnaires and observation tasks are therefore always administered
by research psychologists and research assistants, assisted by graduate
students who have at least an undergraduate degree in psychology, education or
a related discipline. However, the majority of the questionnaires (e.g.
Emotional Awareness Questionnaire, Cognitive Emotional Regulation
Questionnaire, Self Control Scale, Chaos, Hubbub and Order Scale, Fundamental
Needs, Security Scale, Children*s Generalized Trust Beliefs, Capitalization,
Protective Factors Survey, Inclusion of the Other in the Self Scale, Attitudes
about family violence) proposed in the current study were tested in a pilot
study by our group. In this pilot study, both parents and children reported
that these questions were relatively easy to answer and did not cause distress.
Moreover, the observational tasks (AEED and FIT) and part of the questionnaires
* including the questionnaire about severity and duration of IPV - of this
study are approved by the METC for the research project of Prof. Dr. F.
Lamers-Winkelman (protocol ID 80-82435-98-8010/3) on the effectiveness of a
psycho-educational prevention program for children who have experienced IPV.
Finally, assessments take place in clinical settings in close liaison with
therapists. Therefore, the risk with participating in this project is
considered small. Nevertheless, should a child or a parent seem adversely
affected by the questionnaires or observational tasks as observed by the
researchers or therapist, it may be decided to (temporarily) discontinue
participation in the project.
With respect to the study procedure, the intermediate assessment (session 1, 9
and 5) will take 10 minutes for parent and child. The administration of
observational tasks, questionnaires, and physiological assessment will take
place on a separate day before the treatment starts. The administration of
questionnaires will take place after the last treatment session to prevent it
from affecting the therapy and to minimally burden parents and children.
The study has not been done before and cannot be carried out with adults, but
only with children who have experienced IPV. The study is therefore
group-related.
Van der Boechorststraat 1
Amsterdam 1081 BT
NL
Van der Boechorststraat 1
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Study 1: Mediators and moderators of the effects of IPV on child adjustment study;IPV sample;* The child has been exposed to IPV (or violence between a parent and a cohabitant).
* The child is no longer exposed to IPV (or violence between a parent and a cohabitant).
* The child is between the age of 4 and 12.
* Both custodial parents gave written informed consent.;Comparison group
* The child has not experienced IPV or any other type of child abuse
* The child is between the age of 4 and 12
* Custodial parents gave written informed consent;Matching criteria:
* Child*s age
* Child*s gender
* SES
* Family structure (single-parent families and two-parent families)
* Ethnicity;Study 2: The effects of parental components in HORIZON treatment study;* The child has been referred to the HORIZON group therapy.
* The child has been exposed to IPV (or violence between a parent and a cohabitant).
* The child is no longer exposed to IPV (or violence between a parent and a cohabitant).
* The child is between the age of 4 and 12.
* Both custodial parents gave written informed consent.
Exclusion criteria
Study 1: Mediators and moderators of the effects of IPV on child adjustment study;* The child has an intellectual disability (approximately under IQ 80).
* The parent has an intellectual disability (approximately under IQ 80).
* The child and/or parent do not speak sufficient Dutch.
* One of the custodial parents or the child aged 12 or older does not give written informed consent to participate in the study.;Study 2: The effects of parental components in HORIZON treatment study
* The child has an intellectual disability (approximately under IQ 80).
* The child has serious behavioral problems that prevent him or her to function in a group.
* The parent has an intellectual disability (approximately under IQ 80).
* The child and/or parent do not speak sufficient Dutch.
* One of the custodial parents or the child aged 12 does not give written informed consent to participate in the study.
Design
Recruitment
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 | NL39277.029.12 |