Trials / Recruiting
RecruitingNCT06065865
'Effectively Intervening in Traumatized Parents and Young Children After Structural Domestic Violence: A Multiple Baseline Analysis'
'Effectively Intervening in Traumatized Parents and Children After Structural Domestic Violence: A Multiple Baseline Analysis'
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Universiteit Leiden · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Guidance document | The main intervention of interest is the guidance document, which is explained under 'Arms'. Within the treatment trajectory, that is based on the guidance document, the participants can receive a combination of NIKA, and parent and child can both get EMDR-therapy. The therapies are combined in one treatment trajectory. NIKA consists of 5 weekly sessions during which participants are videotaped by a trained therapist. The therapist will provide personalized feedback to the parent, which is focused on reducing disrupted parenting behavior and increasing sensitive parenting behavior. EMDR is a brief trauma therapy (in this trial a maximum of six 90-min sessions for the parent and a maximum of six 60-min sessions for the child) aimed at reducing the negative load of the memories of traumatic events. Both parent and child can receive this therapy. During the weekly sessions, the participant is asked to bring the traumatic event to mind while the therapist provides a distracting task. |
Timeline
- Start date
- 2024-05-23
- Primary completion
- 2025-10-01
- Completion
- 2025-10-01
- First posted
- 2023-10-04
- Last updated
- 2025-04-01
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06065865. Inclusion in this directory is not an endorsement.