Lighthouse Parenting Nanai: a Mentalization-based Group Therapy for Caregivers with History of Trauma

A Mentalization-based Intervention to Enhance the Quality of Caregiver-child Interaction and Reduce the Risk of Child Maltreatment: a Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma, Psychological; Child Maltreatment
• Intervention / Treatment: Behavioral: Psychoeducational cards; Behavioral: MBT Lighthouse Parenting Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefanella Costa Cordella, PhD; Phone Number: 800-555-5555; Email: costacordella@gmail.com
• Study Contact Backup: Name: Stefanella Costa; Phone Number: 998889682; Email: costacordella@gmail.com

Study Locations

• Chile
  • Santiago, Chile, 6513491
    • Recruiting
    • University Diego Portales
    • Contact: Stefanella Costa Stefanella Costa, PhD; Phone Number: +56998889682; Email: costacordella@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychoeducation Group; This group receives weekly psychoeducational information	Behavioral: Psychoeducational cards; They will receive weekly information on parenting in the first 3 years of life. They will have direct contact (via WhatsApp) with a child psychologist to ask questions about the material and to refer to specialized support if needed.
Experimental: MBT Lighthouse NANAI; This group receives the psychosocial intervention MBT Lighthouse NANAI	Behavioral: MBT Lighthouse Parenting Program; Lighthouse Parenting Programme, a 12-week intervention for parents, focusing on enhancing mentalizing abilities. It includes weekly group sessions (2hrs) led by 3 trained MBT psychotherapists for 8-12 parents, and fortnightly individual parenting sessions (1hr) with a practitioner. The programme, rooted in Mentalization-Based Treatment (MBT) skills, explores parents mentalizing and their childrens mentalizing and attachment styles through a variety of interactive methods, including multimedia resources and creative activities to stimulate mentalizing. Central to the programme is the metaphor of the parent as a lighthouse, guiding their child. Training for practitioners spanned 4 days, covering MBT and Lighthouse Parenting skills, with an emphasis on experiential learning and self-reflection. Ongoing weekly group supervision will ensure the quality and fidelity of the intervention. Delivered in person at University Diego Portales.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Conducting a Full-Scale Trial: Recruitment, Retention, and Protocol Acceptability Assessed Through Semi-Structured Interviews and Attendance Records	The feasibility of conducting a future full-scale trial will be assessed through the following measures: Participant Acceptability: Assessed via semi-structured interviews to capture participants' understanding, views, and experiences, including potential barriers or facilitators. Clinician Acceptability: Evaluated through in-depth interviews with clinicians, focusing on barriers, facilitators, and perceptions of the intervention. Adherence: Monitored through attendance records, with successful adherence defined as at least 65% of participants attending 40% or more of sessions. Recruitment and Retention: Recruitment tracked by the percentage of invited participants who consent to participate, with retention determined by the attrition rate, targeting no more than 20%.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parenting Stress from Baseline to 6-Month Follow-Up Using the Parenting Stress Index-Short Form (PSI-SF)	Parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF), a 36-item self-report questionnaire. The PSI-SF includes three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, with a Total Stress Score. The minimum score is 36, and the maximum score is 180, with higher scores indicating greater stress. The primary analysis will focus on changes from baseline to the 6-month follow-up after randomization.	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.
Change in Quality of Life in Parents from Baseline to 6-Month Follow-Up Using the SF-36 Health Survey	The quality of life in parents will be assessed using the SF-36 Health Survey, focusing on the Mental Component Summary (MCS) score. The SF-36 includes 36 items across eight domains, with a scoring range from 0 to 100 for each domain, where higher scores represent better health-related quality of life. The primary analysis will track changes in the MCS score from baseline to the 6-month follow-up after randomization.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parental Mentalizing from Baseline to 6-Month Follow-Up Using the Parental Development Interview - Reflective Functioning (PDI-RF)	Parental mentalizing will be assessed using the Parental Development Interview - Reflective Functioning (PDI-RF), a semi-structured interview that evaluates a parent's capacity to reflect on their own and their child's mental states. Scores range from 1 to 9, with higher scores indicating greater reflective functioning. The study will examine changes in PDI-RF scores from baseline to the 6-month follow-up.	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.

Collaborators and Investigators

• Sponsor: University Diego Portales

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2024
• Primary Completion (Estimated): May 5, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: child maltreatment; mentalization-based treatments; , cultural adaptation; caregiving relationship
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Psychological Trauma
• Other Study ID Numbers: Fondecyt3220844; 3220844 (Other Grant/Funding Number: ANID (National Agency for Research and Development of Chile))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data dictionaries available to other researchers after the end of the study
• IPD Sharing Time Frame: July 2024 to July 2029
• IPD Sharing Access Criteria: a proposal that describes planned analyses must be submitted and a data sharing agreement must be signed, contacting the principal investigator by e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No