Child MaltreatmentNCT06889519
Lighthouse Parenting Nanai: a Mentalization-based Group Therapy for Caregivers with History of Trauma
A study testing MBT Lighthouse Parenting Program and Psychoeducational cards in people with Child Maltreatment and Trauma, Psychological, run by University Diego Portales at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Maltreatment, Trauma, Psychological
- What is being tested?
- MBT Lighthouse Parenting Program and Psychoeducational cards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 17 Aug 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
University Diego Portales
Santiago, Santiago Metropolitan, 6513491
Stefanella Costa Stefanella Costa, PhD, +56998889682, costacordella@gmail.com
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Child Maltreatment, Trauma, Psychological
- Being tested
- MBT Lighthouse Parenting Program, Psychoeducational cards
- Keywords
- mentalization-based treatments, , cultural adaptation, child maltreatment, caregiving relationship
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBT Lighthouse Parenting ProgramBehavioural
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.
Psychoeducational cardsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation Group | Active comparator | This group receives weekly psychoeducational information Receives: Behavioral: Psychoeducational cards |
| MBT Lighthouse NANAI | Experimental | This group receives the psychosocial intervention MBT Lighthouse NANAI Receives: Behavioral: MBT Lighthouse Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
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: 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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start17 Aug 2024
- Primary completion5 May 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Diego Portales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanella Costa Cordella, University Diego Portales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889519
- Sponsor's protocol ID
- Fondecyt3220844
- Other IDs
- 3220844
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data dictionaries available to other researchers after the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06889519
- Acronym / sponsor ID
- Fondecyt3220844
- Conditions
- Child Maltreatment, Trauma, Psychological
- Keywords
- mentalization-based treatments, , cultural adaptation, child maltreatment, caregiving relationship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Diego PortalesUniversity, hospital or other
- Study start
- 17 Aug 2024 (actual)
- Primary completion
- 5 May 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation Group | Active comparator | Behavioral: Psychoeducational cardsThis group receives weekly psychoeducational information |
| MBT Lighthouse NANAI | Experimental | Behavioral: MBT Lighthouse Parenting ProgramThis group receives the psychosocial intervention MBT Lighthouse NANAI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBT Lighthouse Parenting ProgramLighthouse 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. | Behavioural | MBT Lighthouse NANAI |
| Psychoeducational cardsThey 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. | Behavioural | Psychoeducation Group |
Primary outcome
Feasibility of Conducting a Full-Scale Trial: Recruitment, Retention, and Protocol Acceptability Assessed Through Semi-Structured Interviews and Attendance Records
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).
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%.
2 secondary outcomes
Change in Parenting Stress from Baseline to 6-Month Follow-Up Using the Parenting Stress Index-Short Form (PSI-SF)
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.
Change in Quality of Life in Parents from Baseline to 6-Month Follow-Up Using the SF-36 Health Survey
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes. data dictionaries available to other researchers after the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBT Lighthouse Parenting Program and Psychoeducational cards in people with Child Maltreatment and Trauma, Psychological, run by University Diego Portales at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefanella Costa Cordella, PhD (800-555-5555, costacordella@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Conducting a Full-Scale Trial: Recruitment, Retention, and Protocol Acceptability Assessed Through Semi-Structured Interviews and Attendance Records (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.