'Effectively Intervening in Traumatized Parents and Young Children After Structural Domestic Violence: A Multiple Baseline Analysis'

NCT06065865 | Recruiting DMC

• 1 other identifier: NL84677.018.23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Domestic Violence; PTSD

Keywords

domestic violence; trauma; attachment; individualized treatment

Outcome Measures

Primary Outcomes (4)

• Change in disrupted parenting behavior

  Behavioral observations from the dyads are videotaped and coded with the 'Atypical Maternal Behavior Instrument for Assessment and Classification'; AMBIANCE (Bronfman et al., 2009-2014). The AMBIANCE is used to score parental behavior on five dimensions. Based on the scores on these dimensions, an overall score of the level of disruption is determined. The overall score is determined in a range between 1-7, where a higher score indicates more disruptive parenting behavior.

  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.

• Change in sensitive parenting behavior

  Behavioral observations from the dyads are videotaped and coded with the 'Ainsworth Maternal Sensitivity Scale' (Ainsworth et al., 1974). Based on this scale, an overall score is given for the sensitivity of the parent towards the child. The score is given on a range between 1-9, where a higher score indicates a higher level of sensitive behavior of the parent towards the child.

  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.

• Change in PTSD symptoms of the child

  Measured with the 'Child and Adolescent Trauma Screen'; CATS (Sachser et al., 2017). The CATS consists of 16 items, and every item can be scored on a scale of 0-3. Participants can score on a range between 0-48, where a higher score indicates that the child has more PTSD-symptoms.

  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.

• Change in PTSD symptoms of the parent

  Measured with the 'PTSD checklist for DSM-5'; PCL-5 (Boeschoten et al., 2014). The PCL-5 consists of 16 items, and every item can be scored on a scale of 0-4. Participants can score on a range between 0-80, where a higher score indicates that the parent has more PTSD-symptoms.

  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 (2)

• Quality of life of the child

  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.

• Satisfaction with the treatment trajectory

  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.

Study Arms (1)

Guidance document

EXPERIMENTAL

The intervention that is investigated in this study is a guidance document, which is used to individualize the treatment trajectory for the parent-child dyad. This guidance document includes different factors that are important in deciding on the order of different types of therapy within one treatment trajectory. The document will guide the therapist in tailoring the treatment trajectory towards the needs of the dyad. The treatment trajectory can consist of EMDR-therapy for the parent, EMDR therapy for the child and NIKA for the parent-child relationship. The guidance document will guide the therapist in deciding on the order of the different therapies.

Behavioral: Guidance document

Interventions

Guidance document BEHAVIORAL

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.

Guidance document

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Leiden: lead

Study Sites (1)

HVO Querido

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Willemien van den Dorpel

CONTACT

+317 1527 3667; w.m.van.den.dorpel@fsw.leidenuniv.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: The current study has a single case experimental design (SCED), more specifically, a non-concurrent multiple baseline design.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 4, 2023
• Study Start: May 23, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)