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Table 2 Key questions for THRIVE’s realist process evaluation and how these will be examined

From: A realist process evaluation of Enhanced Triple P for Baby and Mellow Bumps, within a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE): study protocol for a randomized controlled trial

Key questions Data source
How faithfully are MB and ETPB implemented?
 How well do facilitators feel they understand programme content and theory? Observation of facilitator training and implementation, facilitator interviews, and facilitator self-reports on fidelity
 How consistent are programme materials/protocols in directing facilitators what to deliver? Observation of training and review of materials
 What directions are facilitators given about adhering/adapting/personalizing the programme? Observation of training and review of materials
 How confident are facilitators about delivering ETPB or MB? Observation of facilitator training and implementation, facilitator interviews, and facilitator self-reports on fidelity
 What programme content is consistently covered? What content, if any, is missed out and why? Facilitator self-reports on fidelity, supervisor interviews, and observation of selected groups during implementation
 What work do facilitators have to undertake in order to deliver the intervention? Interview at Time 2 (after facilitators gain experience of delivering groups)
 How consistent are facilitators at delivering groups to completion? Facilitator self-reports on fidelity, supervisor interviews, and observation of selected groups during implementation
 What role does peer-assisted support (ETPB) and supervision (MB) have in fidelity? Facilitator and supervisor interviews
 To what extent do facilitator pairings (two deliver each group) affect delivery? Facilitator self-reports on fidelity, supervisor interviews, and observation of selected groups during implementation
What are the mechanisms by which MB and ETPB work, if they do, and who do they work for and how?
 How does the programme’s theory of change explain the functioning of MB/ETPB? Meetings with intervention developers and the research team to agree theory of change models
 What information are facilitators given about programme theory and key mechanisms during training? Observation of training, review of materials, facilitator interviews, and facilitator questionnaires
 How do the programme materials/protocols explain programme theory and mechanisms? Review of materials and observation of training
 How well are key mechanisms understood by facilitators (at the point of training and later during implementation)? Observation of facilitator training and selected groups during implementation, facilitator interviews, and facilitator self-reports on fidelity
 What do facilitators think of the intervention and its key mechanisms? Facilitator interviews, questionnaires, and facilitator post-session evaluation
 How well do participants like the interventions? Observation of selected groups, participant interviews, and questionnaires (facilitator’s perspectives will also be considered)
 How do participants respond to knowledge on infant and child development in ETPB and MB? Participant interviews and questionnaires, and observation of selected groups (facilitator’s perspectives will also be considered)
 How do participants respond to parenting skills, partner skills content, and home-based practice in ETPB? Participant interviews and questionnaires, and observation of selected groups (facilitator’s perspectives will also be considered)
 How do participants respond to the nurturing aspects of MB, along with self-care, relaxation, and planned social activities in MB? Participant interviews and questionnaires, and observation of selected groups (facilitator’s perspectives will also be considered)
 How do participants respond to exploration of their past and present difficulties in MB? Participant interviews and questionnaires, and observation of selected groups (facilitator’s perspectives will also be considered)
 How does the experience of group sessions contribute to, or inhibit, the change mechanisms? Participant interviews at Time 2 (3–12 months following birth)
What contextual factors are necessary for the programmes to function, or might prevent them functioning?
 What factors affect identification of suitable mothers-to-be and the referral process? Interviews with referring practitioners, fieldworker observations, and interviews with managers
 What are facilitator’s professional backgrounds? Questionnaire and interviews with facilitators
 What is the facilitators’ knowledge of, views on, and interest in MB/ETPB? Any experience of delivering parenting interventions? Questionnaire and interviews with facilitators
 What is the facilitators’ interest in, empathy and respect for, individual biographies and circumstances of mothers? Interviews with facilitators and observation of training and selected groups during implementation
 What are facilitators’ views on parenting interventions and what are their own experiences of parenting and of being parented? Questionnaire and interviews with facilitators
 How do facilitators manage MB/ETPB with other commitments? Interviews with facilitators
 How do facilitator managers view involvement with THRIVE? Interviews with managers and facilitators
 To what extent do facilitator pairings affect facilitators’ experiences of delivering ETPB and MB? Interviews with facilitators and intervention developers/supervisors, post-session evaluation reports
 How do facilitators feel about their engagement with, and response from, participants? Interviews with facilitators and observation of selected groups during implementation
 What is the suitability of venues for programme? Observation of selected groups during implementation and post-session evaluation (facilitator and participant); interviews with participants and facilitators
 What are mothers’ backgrounds (key relationships; social context; nature of social and health care needs)? Mother-to-be questionnaires and interviews; observation of selected groups during implementation
 How does mother engage with group? Observation of selected groups during implementation and post-session evaluation (facilitator and participant); interviews with participants
 What benefits does social interaction within the group offer participants? Are there any unintended consequences? Observation of selected groups during implementation and post-session evaluation (facilitator and participant); interviews with participants
 How do intervention group dynamics affect the experience of participation/retention? Observation of selected groups during implementation and post-session evaluation (facilitator and participant); interviews with participants; interviews with non-attenders to explore reasons
 How do vulnerabilities (e.g. mental health, drug use or stress) affect engagement? Interviews with mothers-to-be and observation of groups; participant and facilitator post-session evaluation
 How do material circumstances affect retention/adherence, e.g. poverty? Interviews with mothers-to-be (attenders and non-attenders) and facilitator interviews Time 2
 How do families affect adherence? Interviews with mothers-to-be and observation of selected groups during implementation
  1. ETPB Enhanced Triple B for Baby, MB Mellow Bumps