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Table 3 Key assumptions, process interventions and indicators relating to the Theory of Change for the proposed intervention

From: Developing a complex intervention to support pregnant women with mild to moderate anxiety: application of the Medical Research Council framework

Assumptions
a
1. Midwives and midwifery support workers are motivated to apply to be trained and participate as intervention facilitators; Maternity mangers are willing to release midwives and midwifery supporters time to complete training and facilitate the intervention; Intervention facilitators are supported by specialist PMH teams and professional midwifery advocates
2. Community midwives are confident and competent to delivery anxiety screening tools; Community midwives feel confident to discuss perinatal mental health with women and create the right context for women to disclose their symptoms and access supportive services
3. Specialist perinatal mental health teams and psychological services support the intervention as a service for women with sub-threshold symptoms of anxiety
Specialist perinatal mental health teams and psychological services are willing to support intervention facilitators by providing training in supporting women with anxiety and provide advice and referral pathways for women who are identified as having more severe symptoms or requiring more specialist support
4. Women are willing to disclose their symptoms and women with mild to moderate symptoms of anxiety are willing to attend and engage with the intervention
Women who develop more severe symptoms or are identified by intervention facilitators are requiring specialist support are willing to be accept a referral to specialist PMH services for assessment and treatment
Interventions
iv
2. Recruitment and training of facilitators
1. Intervention co-ordinator trained to monitor the intervention fidelity, measure outcomes and support facilitators across maternity systems
3. Training of community midwives to effectively screen for symptoms of anxiety and refer women with mild to moderate anxiety to intervention facilitators
Intervention facilitators to raise awareness of the intervention in local community teams
4. Establish a multi-disciplinary stakeholder team to support the implementation of the intervention
5. Women who develop more severe symptoms or are identified by intervention facilitators are requiring specialist support are referred to specialist PMH services for assessment and treatment
Indicators
id
2. Facilitators assessment of the usefulness of training and preparedness to facilitate the intervention
3. 80% of community midwives are aware of the intervention and know how to refer women to intervention facilitators; 80% of women who are identified with mild to moderate symptoms of anxiety and are eligible for participation are referred to intervention facilitators
1. Intervention fidelity assessment reaches pre-agreed standards; Facilitators feel well supported in their roles; The intervention is implemented across maternity care systems
4. Women attend 75% of intervention sessions; Rates of appropriate referrals to specialist services
5. Women report an improvement in generalised and pregnancy-specific anxiety scores (pre-agreed % in improvement); Women’s evaluation of the acceptability and usefulness of the intervention; Improvement in infant outcomes; Improvement in perinatal mental health in the postnatal period (3, 6 and 12 months)