Early years: THRIVE trial
Women vulnerable in pregnancy (e.g., mental health issues, abuse, addiction, been in care) are likely to be more anxious, depressed and produce higher levels of stress-related hormones than women who are not. Evidence is growing that depression, stress and anxiety in pregnant women can:
1. have adverse consequences that permanently affect the baby’s response to stress and
2. disrupt the mother’s ability to be sensitive to her baby.
Both these pathways are likely to harm mother-baby interactions. Since poor mother-baby interactions and maternal mental health strongly predict child maltreatment, prenatal rather than postnatal interventions may be more effective in preventing harm to infants due to their mother’s maladaptive coping in adverse circumstances.
We have received funding from the National Institute for Health Research (NIHR) to conduct a three-armed randomised controlled trial to compare the cost-effectiveness of two interventions in improving both mother-child interaction and maternal mental health: Enhanced Triple P for Baby (ETPB) and Mellow Bumps (MB).
The THRIVE trial is one of the first rigorous evaluations of parenting interventions designed to promote mother-infant wellbeing amongst vulnerable and hard to reach populations to be conducted in the UK. It will recruit 600 women identified as vulnerable in pregnancy due to mental health difficulties, substance misuse, domestic violence etc. and randomly allocate them to one of three arms: ETPB, MB or treatment as usual. The primary outcomes will be maternal mental health and the quality of mother-child interaction when the babies are 6 months old. Language development will be a secondary outcome when the children are 18 months.
A process evaluation will investigate: the fidelity of programme delivery; practitioners’ characteristics, perceptions and motivation; mothers’ engagement; fathers’ or partners’ perceptions of the interventions and the research, and their influence on mothers’ engagement; the importance of different intervention components; and contextual factors facilitating or inhibiting delivery and participation. Post-trial quantitative analysis will use the rich data on participant characteristics to investigate which mothers benefited most from the interventions. All practitioners will complete post-session protocol adherence checklists and a practitioner questionnaire, and ~8 key practitioners will be interviewed in depth. We will interview practitioner supervisors to try and independently gauge levels of practitioner motivation. All mothers will be asked to complete a brief evaluation questionnaire after each session. Ten mothers in each arm will be interviewed in-depth, and a further 20-30 will be interviewed to address emerging issues during the trial.
The interventions have important similarities and differences. Both aim to reduce maltreatment and improve socio-developmental outcomes for children; both work with women from 20 weeks of pregnancy; are run in groups of ~8 participants; are delivered in local community venues by two trained practitioners who each received 5 days training; include information on infant development; and incorporate cognitive behavioural therapy to improve mothers’ coping in a general and parenting context. Both are cheaper (~£650/family) than the Family Nurse Partnership, which is currently being evaluated in the UK and costs ~£3,000/family.
However, they have fundamental differences in focus that may influence how effective they are at reducing child maltreatment. They have different theoretical emphasis, length of perinatal phase, level of fathers’ involvement and content.
Enhanced Triple P for Baby
Triple P for Baby is designed to be universal, but the ‘enhanced’ level , ETPB, is design to address additional maternal vulnerability when identified. It has 4 antenatal group sessions and four postnatal telephone consultations with a further four sessions offered to address any additional maternal vulnerability in this group. ETPB sessions take from 30 minutes (telephone) to two hours (group) and the intervention is ~14 hours in total. ETPB‘s emphasis is on families and includes fathers. It incorporates social learning principles and has skills-based content around expectations of, and coping with, the new challenges of parenthood whilst maintaining a happy family.
MB is underpinned by attachment theory and designed to target mothers who are vulnerable in pregnancy. It involves seven antenatal group sessions (2 hours each) and focuses on mothers, although fathers are invited to one session. The content focuses on nurturing mothers’ self care, providing mothers with guided reflection, encouraging nurturing of the foetus/baby, engagement with the foetus/baby and synchrony in the mother-foetus/infant relationship.