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Background Need-oriented family support programs are examples of voluntary-based interventions increasingly recognized by the public sector as an important contribution to health and social care provision. Voluntary interventions are attractive because of their focus on activism, inclusion, and participation, but also their low cost and easy accessibility. There is an increasing demand for documentation of the effectiveness of family support programs. Methodologically sound studies are, however, limited and findings are generally inconsistent. This trial aims to assess the effectiveness of the volunteer-based intervention Family Club Denmark on parental stress, mental health, development and well-being of parents and children and to get insight into the experiences of both volunteers and families. Methods This is a prospective quasi-experimental trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group. Participants are families with children aged 2–12 years who wish to participate in the program. Participants are allocated to intervention primarily after a first-come-first-serve principle, and further families will join the wait-list and be offered participation after around 6 months. Quantitative data are collected through web surveys at three time-points: at baseline, post-intervention (6 months after baseline), and follow-up (12 months after baseline). The primary outcome is mental health. Secondary outcomes include parenting behavior, parenting stress, self-efficacy and self-worth, family routines and child well-being. Qualitative data are collected through observations, focus groups, and interviews. Discussion This trial is among the first experimental studies of a group-based third sector need-oriented family support program offered to a wide array of families. The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines. Furthermore, the trial will provide knowledge on volunteer, parent, and child experiences with participating in the intervention and knowledge on how to conduct experimental trails in a complex volunteer environment. Trial registration ClinicalTrials.govNCT03657888 (registered 29.08.2018).

Background Inequality in health can have profound short- and long-term effects on a child’s life. Infants develop in a responsive environment, and the relationship between mother and infant begins to develop during pregnancy. The mother’s ability to bond with the fetus and newborn child may be challenged by mental health issues which can cause impaired functioning and poorer health outcomes. Families with complex problems need interdisciplinary interventions starting in early pregnancy to be prepared for motherhood and to ensure healthy child development. This study aims to examine the effects of an early and coordinated intervention (the Family Clinic and Municipality (FACAM) intervention) offered to vulnerable pregnant women during pregnancy and the child’s first year of life on the mother-child relationship, maternal social functioning, mental health, reflective functioning, well-being, parental stress, and the development and well-being of the child. Methods The study is a prospective randomized controlled trial where we will randomize 320 pregnant women enrolled to receive antenatal care at the family clinic at Odense University Hospital, to either FACAM intervention or usual care. The FACAM intervention consists of extra support by a health nurse or family therapist during pregnancy and until the child starts school. The intervention is most intensive in the first 12 months and also includes attachment-based support provided either individually or in groups. The participants are assessed at baseline, and when the infant is 3 and 12 months old. The primary outcome is maternal sensitivity measured by the Coding Interactive Behavior (CIB) instrument. Secondary outcomes include prenatal parental reflective functioning, mental well-being, depressive symptoms, breastfeeding duration, maternal satisfaction, child development, parent competence, parental stress, and activities with the child. Discussion The trial is expected to contribute knowledge about the effect of early coordinated support in antenatal and postnatal care for vulnerable pregnant women and their families. Trial registration ClinicalTrials.gov NCT03659721. Registered on September 6, 2018

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