Lighthouse Parenting Nanai: a Mentalization-based Group Therapy for Caregivers with History of Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Diego Portales
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MBT Lighthouse Parenting Program
BehavioralLighthouse 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.
Psychoeducational cards
BehavioralThey 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Psychoeducation GroupActive comparator 1 intervention
Group B: MBT Lighthouse NANAIExperimental treatment 1 intervention
Trial outcomes
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%.
Time frame
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
1
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.
Time frame
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.2
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.
Time frame
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)
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov