Clinical trial NCT06889519: Lighthouse Parenting Nanai: a Mentalization-based Group Therapy for Caregivers with History of Trauma
Official title: A Mentalization-based Intervention to Enhance the Quality of Caregiver-child Interaction and Reduce the Risk of Child Maltreatment: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Maltreatment
Trauma, Psychological
Keywords: mentalization-based treatments
, cultural adaptation
child maltreatment
caregiving relationship
Lead sponsor: University Diego Portales
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this feasibility randomized controlled trial is to evaluate the effectiveness and acceptability of the Lighthouse Mentalization-Based Treatment Parenting Program (Lighthouse MBT-P) as an intervention for parents at risk of maltreating their children. The study focuses on parents with a history of childhood trauma, aiming to improve parent-child relationships, reduce parenting stress, and ultimately decrease the risk of child maltreatment.

The goal of this study is to test how well the Lighthouse Mentalization-Based Treatment Parenting Program (Lighthouse MBT-P) works for parents who may be at risk of harming their children. The program aims to help parents understand and manage their own and their children's emotions better. By improving these skills, the program hopes to reduce stress in parenting and lower the chances of child abuse or neglect.

The main questions this study will answer are:

* Can parents follow and complete the Lighthouse MBT-P program?
* Does the program help lower stress in parenting and improve relationships between parents and their children?

Participants in this study will:

* Attend weekly group sessions for 12 weeks. These sessions will teach them how to better understand and manage emotions.
* Take part in discussions led by trained psychologists.

Researchers will compare the results of parents who take part in the Lighthouse MBT-P program with those who receive standard parenting support to see which approach works better.

Detailed description: This study is a feasibility randomized controlled trial designed to assess the Lighthouse Mentalization-Based Treatment Parenting Program (Lighthouse MBT-P) for parents who are at risk of maltreating their children. The Lighthouse MBT-P program is specifically tailored for parents with a history of trauma and aims to enhance their mentalizing abilities-helping them better understand and reflect on their own and their children's emotions and thoughts. By improving these skills, the program intends to strengthen parent-child relationships, reduce parenting stress, and ultimately decrease the risk of child maltreatment.

Study Design:

The study is being conducted at Diego Portales University in Santiago, Chile, with a total of 60 participants who will be randomly assigned to one of two groups: the intervention group receiving the Lighthouse MBT-P program and a control group receiving standard psychoeducational support. The intervention will consist of weekly 2-hour group sessions over 12 weeks, where participants will engage in psychoeducation and reflective discussions, facilitated by trained psychologists. These sessions aim to provide parents with the tools to improve their emotional regulation, understand their children's needs better, and develop healthier parenting practices.

Study Phases:

Cultural Adaptation: The Lighthouse MBT-P program has been culturally adapted to ensure its relevance and effectiveness within the Chilean context. This phase involved consultations with local experts, community stakeholders, and pilot testing with a small group of parents to refine the intervention content and delivery methods.

Clinician Training: Therapists who will deliver the Lighthouse MBT-P program have completed a comprehensive training program, including a three-day workshop and ongoing bi-weekly supervision by an MBT specialist. This training ensures that the intervention will be delivered consistently and effectively, adhering to the principles of mentalization-based treatment.

Intervention Delivery: The intervention group will participate in the Lighthouse MBT-P sessions, focusing on enhancing parental mentalizing abilities. The content will cover topics such as emotional regulation, understanding children's behaviors, and managing stress in parenting. Sessions will be conducted online, allowing for greater accessibility for participants.

Data Collection: Data will be collected at multiple time points, including baseline, post-intervention, and follow-up, to assess the feasibility and acceptability of the program, as well as preliminary indicators of its effectiveness in reducing parenting stress and improving parent-child relationships.

Analysis and Interpretation: The data collected will be analyzed using both quantitative and qualitative methods to determine the feasibility of the program and to identify any barriers or facilitators to its implementation. The results will inform decisions about whether to proceed with a full-scale randomized controlled trial and guide any necessary adjustments to the program.

Significance:

This study addresses a critical gap in the availability of trauma-informed, attachment-based interventions for parents at risk of child maltreatment in Chile. By evaluating the feasibility of the Lighthouse MBT-P program, this research aims to provide a foundation for larger-scale interventions that could significantly impact the prevention of child maltreatment and improve the well-being of vulnerable families.

Eligibility criteria: Inclusion Criteria:

1. Biological parents of children (0-36 months old) with custody of their child.
2. Parents who have gone through adverse childhood experiences, have a history of parental substance abuse or incarceration, have current exposure to relationship violence, or social isolation, or have lost custody of a child in the past.
3. Parents must be over the age of 18.

Exclusion Criteria:

1. Parents who are unable to provide informed consent due to mental or cognitive impairment,
2. Parents not fluent in Spanish.
3. Child's diagnosis of autistic spectrum disorder or severe cognitive delay.

Primary outcomes:
measure: Feasibility of Conducting a Full-Scale Trial: Recruitment, Retention, and Protocol Acceptability Assessed Through Semi-Structured Interviews and Attendance Records
timeFrame: Measured continuously from the start of recruitment through the end of the intervention period (12 weeks for control group, 26 weeks for intervention group).
Secondary outcomes:
measure: Change in Parenting Stress from Baseline to 6-Month Follow-Up Using the Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Measured at three specific points: baseline (pre-intervention), end of treatment (12 weeks for control group/26 weeks for intervention group), and 6-month follow-up.
measure: Change in Quality of Life in Parents from Baseline to 6-Month Follow-Up Using the SF-36 Health Survey
timeFrame: Measured at three specific points: baseline (pre-intervention), end of treatment (12 weeks for control group/26 weeks for intervention group), and 6-month follow-up.
Other outcomes:
measure: Change in Parental Mentalizing from Baseline to 6-Month Follow-Up Using the Parental Development Interview - Reflective Functioning (PDI-RF)
timeFrame: Measured at three specific points: baseline (pre-intervention), end of treatment (12 weeks for control group/26 weeks for intervention group), and 6-month follow-up.
Locations:
city: Santiago
country: Chile
facility: University Diego Portales
Study officials:
References: