Evaluating the Mentalization-based Treatment Lighthouse Parenting Programme: Protocol of a Feasibility and Acceptability Quasi-Experimental Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Lighthouse Parenting Programme: The Lighthouse Parenting Programme is a 20-session Mentalization-based Treatment (MBT) for groups of parents, that aims to reduce child maltreatment potential by increasing caregivers' mentalizing capacity. Through the use of parental mentalization-related metaphors, therapists support parents in exploring their child's attachment experiences and their own, making sense of misunderstandings in the relationship with their child, inhibiting harmful responses and repairing ruptures (Byrne et al., 2018). Sessions include psychoeducation and reflective discussions. Each Lighthouse group is composed of 8 to 12 parents. Sessions are delivered weekly by two facilitators (including at least one qualified psychologist), lasting approximately 2 hours each. Facilitators will undergo a 6-day training course, including theoretical-experiential didactic activities, led by the author of the programme. Facilitators receive weekly group clinical supervision (1.30 - 2 hours) by an MBT specialist.

Treatment-as-usual (TAU): Treatment-as-Usual (TAU) refers to standard support delivered at the institutions in line with routine practice, such as individual psychological support and home-visiting. TAU can be variable and tailored to each participant, therefore, intervention characteristics will be monitored and registered throughout the trial.

Study summary

The goal of this study is to learn whether it is practical and acceptable to deliver the Lighthouse Parenting Programme and to carry out the planned research procedures with caregivers involved with Child Protection Services. The study will also gather early information to help plan a future, larger evaluation study.

The main questions it aims to answer are:

* Is it possible to recruit caregivers involved with Child Protection Services into this type of study?
* Can the Lighthouse Parenting Programme be delivered as intended by trained facilitators?
* Are the questionnaires and assessment procedures suitable for caregivers and sensitive to change over time?
* Is the Lighthouse Parenting Programme acceptable to caregivers and facilitators?
* Is participation in the study acceptable to caregivers?

Researchers will compare caregivers who take part in the Lighthouse Parenting Programme with caregivers who receive usual services to see whether there are early signs of change in parenting- and child-related outcomes that can inform future research.

Participants will take part in the Lighthouse Parenting Programme, consisting of 20 weekly group sessions focused on enhancing caregivers' capacity to understand their own and their child's mental states (mentalization), or will receive the usual services and supports provided by Child Protection Services. Participants will also complete questionnaires and interviews about their own experiences, parenting, and their child's wellbeing at different points during the study.

Eligibility

Primary outcome measure(s)

• Feasibility of the recruitment strategy — From recruitment (throughout the 2 months prior to baseline) to baseline assessments
  Feasibility of the recruitment strategy will be assessed based on the participant enrollment rate, that is the ratio of acceptance to enter the study by the number of service users invited. This will be tracked through recording the number of service users approached for recruitment and responses to invitations (whether accepting or not), including reasons for rejecting assessed through qualitative feedback from participants. Data will be systematically registered in Excel spreadsheets.
• Feasibility of data collection procedures: sensitivity to change of clinical outcome measures — From baseline to follow-up assessments (8 months after the treatment starts)
  Sensitivity to change of clinical outcome measures will be evaluated based on the analysis of within-group change over time, particularly the direction and magnitude (e.g., effect sizes, mean differences) of observed changes in relation to intervention targets. This assesses whether measures can detect expected change.
• Feasibility of data collection procedures: distributional properties of clinical outcome measures — From baseline to follow-up assessments (8 months after the treatment starts)
  Distributional properties of clinical outcome measures will be evaluated based on descriptive statistics of scores, including score distributions, variability (e.g., SD, range), floor effects and ceiling effects. Results will reflect how appropriately each measure behaves in the sample.
• Feasibility of data collection procedures: realiability of clinical outcome measures — From baseline to follow-up assessments (8 months after the treatment starts)
  Reliability of clinical outcome measures will be evaluated based on the internal consistency coefficients (e.g., Cronbach's alpha) of scales within the study sample.
• Feasibility of data collection procedures: construct coherence of clinical outcome measures — From baseline to follow-up assessments (8 months after the treatment starts)
  Construct coherence of clinical outcome measures will be evaluated based on correlations between theoretically related constructs. This evaluates whether measures behave as expected theoretically.
• Feasibility of data collection procedures: completion rates of clinical outcome measures — From baseline to follow-up assessments (8 months after the treatment starts)
  Completion rates of clinical outcome measures will be evaluated by calculating the percentage of participants that completed the psychological assessments at each time point. This reflects procedural feasibility of data collection.
• Feasibility of data collection procedures: missing data on clinical outcome measures — From baseline to follow-up assessments (8 months after the treatment starts)
  Missing data on clinical outcome measures will be evaluated based on missing data rates (percentage of missing data) and patterns (e.g., systematic vs random). This allows to explore the adequacy of clinical outcome measures and, if missing data is substancial and not at random, the factors that may be affecting measure suitability.
• Feasibility of the intervention delivery (based on fidelity to treatment) — From start to completion of treatment delivery (baseline to 5 months after the treatment starts)
  Fidelity to treatment (experimental condition only) will be assessed by a supervisor-informed rating system, specifically developed for this study and adapted from the existing tool used at the ERiC trial (Nick Midgley, Holly Dwyer Hall and Emma Morris, Anna Freud, unpublished 2024), evaluating the quality of the therapists' mentalizing stance on four different dimensions pertaining to key MBT principles, each rated on a 4-point Likert scale, assessed across supervision sessions. Scores ≥3 per dimension are considered satisfactory. Fidelity to treatment will also be evaluated based on the percentage of key treatment activities (experiential and psychoeducational) that facilitators were able to deliver - these will be tracked by facilitators' self-report of activities conducted in each session.
• Feasibility of the intervention delivery (based on participant attendance and retention) — Attendance: From start to completion of treatment delivery (baseline to 5 months after the treatment starts) Retention: From recruitment (throughout the 2 months prior to baseline) to follow-up assessments (8 months after the treatment starts)
  Attendance rates will be calculated based on the mean number of sessions attended by participants; retention rates will be calculated by the percentage of participants that have not dropped-out across different timepoints of the study; reasons for discontinuation will be assessed by qualitative feedback from participants; this data will be registered in Excel spreadsheets.
• Acceptability of the Lighthouse Parenting Programme: perpectives from participants in the experimental condition — At post-test assessments (5 months after the treatment starts)
  Acceptability of the Lighthouse Parenting Programme from participants' perspective will be assessed through semi-structured interviews with participants in the experimental condition focused on their experiences of the programme, their views on the intervention's appropriateness (cultural, clinical, contextual), and potential barriers or facilitators to attending and engaging with the programme
• Acceptability of the Lighthouse Parenting Programme: perpectives from facilitators — At post-test assessments (5 months after the treatment starts)
  Acceptability of the Lighthouse Parenting Programme from the facilitators' perspectives will be assessed through focus groups with facilitator dyads, focusing on their perceptions of the appropriateness of the intervention, barriers and facilitators to participant attendance and to the delivery of the programme
• Acceptability of study procedures: perspectives from participants — At post-test (5 months after treatment starts) and follow-up assessments (8 months after treatment starts)
  Acceptability of study procedures will be assessed through: 1\) Semi-structured interviews, exploring: participants' perspectives on the adequacy of study's procedures, including recruitment strategy and data collection measures (e.g., burden, clarity and relevance). Interviews will be conducted at post-test, given the risk of missing data at follow-up assessments. Participants who attend follow-up assessments will also respond to an additional interview question regarding the acceptability of the follow-up assessment procedures. Both retained participants and those who drop out will be invited to be interviewed. For participants who formally withdraw from the study, the timing of the interview will remain flexible, with priority given to conducting it as soon as possible after withdrawal.
• Acceptability of study procedures: perspectives from facilitators — At post-test assessments (5 months after the treatment starts)
  Acceptability of study procedures will be assessed through focus groups with facilitator dyads, focusing on adequacy e replicability of study's procedures

Trial sites (1)

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