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

NCT06889519 | Recruiting

• 2 other identifiers: Fondecyt32208443220844
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Maltreatment; Trauma, Psychological

Keywords

mentalization-based treatments; , cultural adaptation; child maltreatment; caregiving relationship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Parenting Stress from Baseline to 6-Month Follow-Up Using the Parenting Stress Index-Short Form (PSI-SF)

  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

  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 (1)

• Change in Parental Mentalizing from Baseline to 6-Month Follow-Up Using the Parental Development Interview - Reflective Functioning (PDI-RF)

  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.

Study Arms (2)

Psychoeducation Group

ACTIVE COMPARATOR

This group receives weekly psychoeducational information

Behavioral: Psychoeducational cards

MBT Lighthouse NANAI

EXPERIMENTAL

This group receives the psychosocial intervention MBT Lighthouse NANAI

Behavioral: MBT Lighthouse Parenting Program

Interventions

MBT Lighthouse Parenting Program BEHAVIORAL

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.

MBT Lighthouse NANAI

Psychoeducational cards BEHAVIORAL

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.

Psychoeducation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological parents of children (0-36 months old) with custody of their child.
• 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.
• Parents must be over the age of 18.

You may not qualify if:

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

Sponsors & Collaborators

• University Diego Portales: lead

Study Sites (1)

University Diego Portales

Santiago, Santiago Metropolitan, 6513491, Chile

RECRUITING

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Stefanella Costa Cordella, PhD

CONTACT

800-555-5555; costacordella@gmail.com

Stefanella Costa

CONTACT

998889682; costacordella@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this study, both the participants and the outcomes assessors are blinded to the treatment assignments. Participants are unaware of which one of the interventions are receiving. The outcomes assessors, who are responsible for evaluating the results of the intervention, do not have access to information about which intervention each participant received, ensuring that their assessments are unbiased.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2025
• Study Start: August 17, 2024
• Primary Completion: May 5, 2025
• Study Completion: October 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: July 2024 to July 2029
• 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.

Locations

CL (1)