Clinical trial NCT06065865: 'Effectively Intervening in Traumatized Parents and Young Children After Structural Domestic Violence: A Multiple Baseline Analysis'
Official title: 'Effectively Intervening in Traumatized Parents and Children After Structural Domestic Violence: A Multiple Baseline Analysis'
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Domestic Violence
PTSD
Keywords: domestic violence
trauma
attachment
individualized treatment
Lead sponsor: Universiteit Leiden
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The current study has a single case experimental design (SCED), more specifically, a non-concurrent multiple baseline design.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the effectiveness of an individualized treatment trajectory in which the order of trauma therapy for the parent (Eye movement desensitization and reprocessing (EMDR) therapy), trauma therapy for the child (EMDR therapy) and attachment-based therapy (Dutch short-term intervention for atypical parenting behavior (NIKA)) is tailored towards the complex needs of victimized parents and their young children (4-6 y/o) after domestic violence. The treatment trajectory is based on a guidance document that supports therapists to determine the optimal order of interventions based on a standardized set of factors. The primary goals of this study are:

1. To examine how post-traumatic stress disorder (PTSD)-symptoms of parent and child and parental sensitive and disruptive parenting behavior develop and interact over time, while they follow the individualized treatment trajectory.
2. To test whether the start of the treatment trajectory (e.g. the phase in which parents can receive NIKA and EMDR therapy and their child can receive EMDR therapy) leads to a decrease in disruptive parenting behavior towards the child, an increase in sensitive parenting behavior towards the child, and a decrease in PTSD symptoms of the parent in comparison to the baseline phase.
3. To test whether the start of the treatment trajectory (e.g. the phase in which children can receive EMDR therapy and their parent can receive NIKA and EMDR therapy) leads to a decrease in PTSD symptoms of the child in comparison to the baseline phase.

Detailed description: Rationale:

While the adverse effects of domestic violence on victimized parents and children have been extensively documented, there is still little knowledge on effective intervention approaches for these families. Both parents and children are at risk to develop trauma-related psychopathology after domestic violence. In addition, victimized parents are likely to show disrupted parenting due to their own traumatization (resulting from domestic violence and often also from their own traumatic childhood). This increases the risk for developing a disturbed attachment relationship for the child. Treatment should thus focus at improvement on three levels (parenting behavior and post-traumatic stress (PTSD) symptoms of the parent and the child), and can consist of trauma therapy for parent and child and attachment-based therapy. Since the symptoms in different families may exhibit in different ways, and can interact with each other in a different way, an individualized treatment trajectory that takes these interactions in account may be necessary to allow for maximum symptom reduction.

Study design:

The hypotheses will be tested using a single case experimental design (SCED) study, with a non-concurrent, randomized multiple baseline design. Families who receive treatment after experiencing severe domestic violence will be randomly assigned to a baseline length of 3, 4, 5, 6, 7 or 8 weeks (phase 1), and randomization will occur for two sets of five participants. After the end of the baseline phase, the intervention phase will start, during which dyads will follow an individualized treatment trajectory, consisting of different treatments (phase 2), including EMDR therapy for parent and child to reduce their PTSD symptoms and NIKA to reduce disrupted parenting behavior and increase sensitive parenting behavior. The dyads will participate in weekly appointments throughout the whole duration of the study (both baseline and treatment phase).

Study population:

This study will include 10 parent-child dyads who are residing at a community shelter location in the Netherlands after experiencing domestic violence. Parents with children aged between 4-6 years old will be included if both the parent and the child experience clinically important PTSD-symptoms (based on self-report of the parent). In case that not enough parent-child dyads can be recruited, based on the eligible age range of the child, the age range for the children will be widened, so that children aged between 3-6 years can participate.

Eligibility criteria: Inclusion Criteria:

* The non-offending parent and child are residing in a community shelter because of a combination of problems that includes severe domestic violence
* The child is aged between 4-6 years old (if there is more than 1 child in this age range in the family, the parent will be asked to report on the symptoms of both children, and the child with the most severe PTSD symptoms will participate)
* The parent experiences clinically important PTSD-symptoms, as defined by a PCL-score of ≥31
* The child experiences PTSD-symptoms on a clinical level, as defined by a CATS-score of ≥15

Exclusion Criteria:

* Parents with extreme mental health problems (e.g., psychosis) that directly affect their ability to participate in an intervention and require immediate intervention for the parent

Primary outcomes:
measure: Change in disrupted parenting behavior
timeFrame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
measure: Change in sensitive parenting behavior
timeFrame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
measure: Change in PTSD symptoms of the child
timeFrame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
measure: Change in PTSD symptoms of the parent
timeFrame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Secondary outcomes:
measure: Quality of life of the child
timeFrame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
measure: Satisfaction with the treatment trajectory
timeFrame: Only at the end of the research trajectory (post-test). Depending on the total length of the research trajectory, this will be between 14-25 weeks.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: HVO Querido
Study officials:
References: