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| Name | Class |
|---|---|
| Anna Freud National Centre for Children and Families | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lighthouse Parenting Programme | Experimental | The experimental group will receive the Lighthouse Parenting Programme. |
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| Treatment-as-usal (TAU) | Active Comparator | The control group will receive Treatment-as-Usual (TAU). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lighthouse Parenting Programme | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the recruitment strategy | 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. | From recruitment (throughout the 2 months prior to baseline) to baseline assessments |
| Feasibility of data collection procedures: sensitivity to change of clinical outcome measures | 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. | From baseline to follow-up assessments (8 months after the treatment starts) |
| Feasibility of data collection procedures: distributional properties of clinical outcome measures | 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. | From baseline to follow-up assessments (8 months after the treatment starts) |
| Feasibility of data collection procedures: realiability of clinical outcome measures | 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. | From baseline to follow-up assessments (8 months after the treatment starts) |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic data | Sociodemographic data will be collected, including: age and sex of participant, marital status, level of education, employment status, family income, number of children, age and sex of children, measure of Child Protection applied and duration. | At baseline |
| Parental history of adverse childhood experiences |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Psychology and Education Sciences of the University of Porto | Porto | Porto District | 4200-135 | Portugal |
Individual participant data will not be shared. The study involves a sample recruited from small communities under highly sensitive conditions, namely referrals by Child Protection Services. Given the limited sample size and contextual specificity, there is a risk of participant re-identification even after anonymisation, particularly through the qualitative data (e.g., PDI-RF narratives). As the primary focus of the study is to assess acceptability and feasibility of intervention and research procedures, rather than examining treatment effectiveness, data sharing is not essential to achieving the study's objectives.
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A quasi-experimental study that will adopt a pretest-posttest nonequivalent groups design methodology.
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Participants will not be blinded to treatment condition. Facilitators delivering the interventions will collect pre-test, mid-treatment, and post-test data, by administering standardised questionnaires, which participants will complete autonomously, and conducting a clinical interview only at pre-test. As facilitators will be aware of participants' treatment allocation, they will not be blinded for data collection. The clinical interview, at post-test, will be conducted by assessors who are blinded to treatment allocation; however, given the nature of this measure, it is possible that treatment allocation may be interfered by researchers during data collection. The data analyst will remain blind to group allocation throughout the analysis of all clinical data (standardised questionnaires and clinical interview).
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| Treatment-as-usual (TAU) | Other | 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. |
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| Feasibility of data collection procedures: construct coherence of clinical outcome measures | Construct coherence of clinical outcome measures will be evaluated based on correlations between theoretically related constructs. This evaluates whether measures behave as expected theoretically. | From baseline to follow-up assessments (8 months after the treatment starts) |
| Feasibility of data collection procedures: completion rates of clinical outcome measures | 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. | From baseline to follow-up assessments (8 months after the treatment starts) |
| Feasibility of data collection procedures: missing data on clinical outcome measures | 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. | From baseline to follow-up assessments (8 months after the treatment starts) |
| Feasibility of the intervention delivery (based on fidelity to treatment) | 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. | From start to completion of treatment delivery (baseline to 5 months after the treatment starts) |
| Feasibility of the intervention delivery (based on participant attendance and retention) | 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. | 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) |
| Acceptability of the Lighthouse Parenting Programme: perpectives from participants in the experimental condition | 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 | At post-test assessments (5 months after the treatment starts) |
| Acceptability of the Lighthouse Parenting Programme: perpectives from facilitators | 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 | At post-test assessments (5 months after the treatment starts) |
| Acceptability of study procedures: perspectives from participants | 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. | At post-test (5 months after treatment starts) and follow-up assessments (8 months after treatment starts) |
| Acceptability of study procedures: perspectives from facilitators | Acceptability of study procedures will be assessed through focus groups with facilitator dyads, focusing on adequacy e replicability of study's procedures | At post-test assessments (5 months after the treatment starts) |
Parental history of adverse childhood experiences will be evaluated through the Adverse Childhood Experiences questionnaire (ACE; Felitti et al.1998; Portuguese version by Silva & Maia, 2008). The ACE assesses exposure to potentially traumatic experiences in childhood, such as abuse, neglect, and household adversity (29 items). Includes the following subscales: 1) Emotional abuse, 2) Physical abuse, 3) Sexual abuse, 4) Emotional neglect, 5) Physical neglect, 6) Divorce or parental separation, 7) Exposition to domestic violence, 8) Substance abuse in the family, 9) Mental health or suicide, 10) Incarceration of family member. |
| At baseline |
| Parental Reflective Functioning | Parental Reflective Functioning will be evaluated through the current gold standard measure Parent Development Interview - Reflective Functioning (PDI-RF; Slade et al., 2004). The PDI is an interview-based measure of parental reflective functioning, assessing the parent's capacity to understand their own and their child's mental states. The data analyst is certified by the PDI Institute (https://www.pditraininginstitute.com/) to code the PDI. | At baseline and post-test (5 months after the treatment starts) assessments |
| Child's psychological adjustment (parent-report) | Child's psychological adjustment will be assessed with the parent-report version of the Strengths and Difficulties Questionnaire (SDQ; Goodman et al., 1997, 1999; Portuguese version available at http://www.sdqinfo.com), a brief 25-item screening measure of children's emotional and behavioural symptoms as per reported by parents. The SDQ includes the following subscales: 1) Total Difficulties, 2) Emotional Symptoms, 3) Conduct Problems, 4) Inattention/ Hyperactivity, 5) Peer-Problems, and 6) Prosocial behaviour. | At baseline, post-test (5 months after the treatment starts) and follow-up (8 months after treatment starts) assessments |
| Parenting stress | Parenting stress will be evaluated with the Parenting Stress Scale (PSS; Berry & Jones, 1995; Portuguese version by Algarvio et al., 2018), a 14-item measure to assess perceived stress associated with parenting, balancing parenting demands with rewards and satisfaction. The PSS includes the following subscales: 1) Parental stressors, 2) Parental satisfaction, 3) Lack of control, and 4) Fears and anxieties. | At baseline, post-test (5 months after treatment starts) and follow-up (8 months after treatment starts) assessments |
| Parent cognitions | Parent cognitions will be assessed with the Parent Cognition Scale (PCS; Snarr et al., 2009; Portuguese version by Fernandes et al., 2019), a 30-item measure to assess parents' beliefs, interpretations, and attributions about their child's misbehaviour. The PCS includes two subscales: 1) Child-responsible attributions, and 2) Parent-causal attributions. As a theoretical mediator of change, this outcome will be assessed at two additional timepoints mid-treatment. | At baseline, during treatment (week 7 and week 14 into treatment), post-test (5 months after treatment starts) and follow-up (8 months after treatment starts) assessments |
| Parental emotion regulation difficulties | Parental emotion regulation difficulties will be assessed with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF; Kaufman et al., 2016; Portuguese version by Gouveia et al., 2018). The DERS-SF is a 18-item screening tool that measures difficulties in understanding, accepting, and managing emotions, including impulse control and emotion regulation strategies. It includes the following subscales: 1) Strategies, 2) Goals, 3) Impulse, 4) Clarity, 5) Awareness, 6) Non-Acceptance, and 7) Difficulties in emotion regulation [Total Score]. As a theoretical mediator of change, this outcome will be assessed at two additional timepoints mid-treatment. | At baseline, during treatment (week 7 and week 14 into treatment), post-test (5 months after treatment starts) and follow-up (8 months after treatment starts) assessments |