Background
Aim 1: Understanding the theory of programmes and how they work
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1. Interventions are theories and will therefore have theories of change | |
2. These theories are embedded in social systems | |
3. They are active and effects are produced by, and require, the active engagement of actors | |
4. They are also parts of open systems; there may be unanticipated events, political change, inter-programme and intra-programme interactions that influence how interventions bring about change | |
Aim 2: To understand and explain how, why, and for whom programmes work when implemented
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5. Identify intervention mechanisms; emphasis on how an intervention works | |
6. The importance of context; conditions in which the intervention is introduced and which are relevant to its functioning | |
7. Outcome patterns; intended and unintended consequences | |
8. Context-mechanism-outcome pattern configurations (CMOs) explaining the theory of how programmes activate mechanisms, amongst whom, and in what conditions. It is the synergy of CMO pattern configurations that is of interest, as opposed to merely separately identifying and describing ‘mechanisms’, ‘contexts’, and ‘outcomes’ Adapted from Pawson and Tilley [26] |
Methods
Stage I of process evaluation design: understanding the theory of how ETPB and MB work
Developing theory of change models
Enhanced Triple P for Baby (ETPB)
Mellow Bumps (MB)
Stage II of process evaluation design: key questions
Key questions | Data source |
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How faithfully are MB and ETPB implemented?
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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?
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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?
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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 |
Recruitment to the RCT
Data collection
Tell me about your professional background and how your experience relates to current role | |
What attracted you to this role? | |
Previous experience of working with vulnerable families | |
How do you envisage working with mothers-to-be and their partners likely to be recruited to THRIVE? | |
Previous experience of delivering parenting groups | |
What do you hope to get out of training? | |
How do you feel about delivering MB or ETPB? | |
Any prior knowledge of, or experience of delivering, MB or Triple P? | |
Views of manager with regard to taking on this new role |
Describe experiences of delivering the intervention | |
Explore understanding what the sessions consist of and how this developed | |
Explore how closely the course content was adhered to | |
Did you face any challenges when running the group sessions? | |
Would you change anything about the interventions? If so, what and why? | |
Were there any barriers to women/partners engaging in the sessions? If so, what? | |
Who do they think group/individual sessions worked best for? | |
Explore training and any refresher sessions. Did it equip you to deliver the groups? What work did you have to do following training to enable you to deliver the interventions? | |
Experience of peer supervision (ETPB) or a supervisory process (MB) |
Relevant background information (e.g. relationship with partner; own parents; friends; other children) and circumstances surrounding the pregnancy | |
Contact with services (care as usual) and support during pregnancy | |
Understanding how they came to be referred to trial, the nature of additional needs, feelings about being referred | |
Experience of attending sessions (e.g. atmosphere of groups; content, understanding of what key mechanisms were/what was supposed to be achieved) | |
Relationships with participants and facilitators | |
Has the nature of the group added to or taken away from content (dynamics; mix of vulnerabilities)? | |
Partner/family response to participation | |
To what extent has the intervention helped? In what ways? Any negative consequences? | |
Hopes for motherhood |
How has life been since last interview (and since baby was born)? | |
Any changes/major life events since last interview | |
Contact with services since birth (care as usual) | |
Reflections on participating in the intervention | |
Explore the legacy of the intervention | |
Talk about any changes in the following as a result of the intervention (e.g. self-esteem; self-confidence generally and as a parent; anxiety generally and as a parent; self-accepting generally and as a parent; feelings of guilt generally and as a parent) | |
Did the intervention improve/prompt change (e.g. knowledge/understanding of infant needs; attitudes regarding being a parent/child rearing (how); parenting skills; responding to baby’s needs; behaviour regarding partner (and his/her behaviour towards you); feelings; self-awareness; nature of social contact with group members; on-going or new support? Any feelings arising about own childhood and how parented?) |
Participants will be asked to give their written consent for interviews to be audio recorded | |
Interviews will be conducted at a time convenient for participants, usually in their home | |
Interviews will be transcribed verbatim, anonymised, and cross-checked for quality | |
Field notes will be written immediately following interviews to note unrecorded discussion and reflect on key themes | |
The main themes will be independently coded across a sample of interviews by two researchers using Nvivo 10 | |
A coding frame will be agreed by two researchers | |
All data will be coded using this coding frame and further additions/adaptions will be discussed | |
Themes will be summarized using the one sheet of paper method (OSOPs) [40] Analysis of themes will be developed through writing and wider discussion with the process team |
Setting up | |
Getting there (transport), reception on arrival, comfort of room and facilities | |
What session is being delivered: content and materials, including how closely this complies with MB/ETPB packs/content of training | |
Who is delivering session? | |
How many mothers-to-be (and partners) in attendance? | |
Style of facilitator | |
How mothers-to-be/parents interact with each other | |
Facilitator/mother-to-be/parent interaction | |
Level and nature of participation | |
Facilitator style | |
Key mechanisms. How do participants react to these? | |
Response to any home-based tasks that may have been set between sessions | |
Atmosphere/dynamics of the group | |
What happens when the class ends? | |
Researcher’s role, as negotiated with facilitators and participants |