Family Club Denmark: A Quasi-Randomized Study of a Volunteer-Based Intervention to Support Vulnerable Families.

Volunteer interventions play a vital role in supporting families by offering accessible and community-based resources outside the formal professional sector. This study examines the impact of the volunteer intervention known as Family Club Denmark (FCD) on the well-being of parents and children. FCD aims to provide families with positive experiences and support relationship building. The intervention, open to families from diverse social backgrounds, comprises volunteer-led family clubs where parents and children aged 2-12 years engage in activities and meals. We allocated 510 families (363 vulnerable families) to FCD or placed them on a waiting list based on a first-come, first-served principle. We conducted baseline, post-intervention, and follow-up assessments through questionnaires, observations, and interviews. On average, families participated in 5.8 sessions, with both families and volunteers reporting high satisfaction. When compared to control families, we find that vulnerable FCD parents feel more confident playing with their children (p = 0.04, [0.01; 0.40], d = 0.25), require less assistance in playing with their children (p = 0.01, [-0.34; -0.05], d = 0.33), and report that their children have a more challenging time forming friendships (p = 0.01, [-0.51; -0.09], d = 0.29). However, we did not find significant effects on mental health, parenting stress, self-efficacy, self-worth, family routines, or child well-being. We observed similar results for the full sample. The discovery that parents feel more confident playing with their children after participating in FCD highlights the vital role of volunteer-based interventions in enhancing parental engagement and fostering positive parent-child interactions. Trial registration: ClinicalTrials.gov NCT03657888 (registered 29 August 2018).

Effects on Child Development and Parent-Child Interaction of the FACAM Intervention: A Randomized Controlled Study of an Interdisciplinary Intervention to Support Women in Vulnerable Positions through Pregnancy and Early Motherhood.

Health inequality can have a profound impact on a child's life. Maternal mental health challenges can hinder bonding, leading to impaired functioning and poorer child outcomes. To provide extra support for vulnerable pregnant women, the FACAM intervention offers the services of a health nurse or family therapist from pregnancy until the child starts school. This study examined the effects of FACAM intervention on pregnant women in vulnerable positions and their children until the child turned two years old. We randomly assigned 331 pregnant women to either FACAM intervention or care as usual and assessed them at baseline and when the infant was 3-6, 12-13.5, and 24 months old. The primary outcome was maternal sensitivity measured by Coding Interactive Behavior (CIB). Secondary outcomes included the parent-child relationship, child social-emotional development, child developmental progress, parent-child interaction, and child development. Our findings indicate that care-as-usual children were significantly more involved than FACAM children when the child was 4-6 months old (b = -0.25, [-0.42; -0.08] d = -0.42). However, we suspect this result is due to a biased dropout. We did not find any significant differences in any other outcomes. Therefore, the study suggests that the FACAM intervention is not superior to care as usual regarding child development and parent-child interaction outcomes.

Minding the Baby versus usual care: study protocol for a quasi-cluster-randomized controlled study in Denmark of an early interdisciplinary home-visiting intervention for families at increased risk for adversity.

BACKGROUND: Inequality in health can have profound effects on a child's opportunities later in life. To prevent these downstream effects in families at increased risk of adversity, programs are needed to provide support and improve well-being across several domains. The present trial is aimed at assessing the effectiveness of the Minding the Baby® (MTB) home visiting intervention in improving the mother-child relationship, parental reflective functioning, well-being, and mental health, as well as child development and well-being in families at known risk of adverse health, relational, and developmental outcomes. METHODS: The study is a pragmatic, prospective, quasi-cluster-randomized controlled trial in which seven Danish municipalities were randomized to MTB training in either 2018 or 2019. A total of 250 pregnant women at increased risk of adversity will be recruited (75 care as usual families and 175 intervention families). Care as usual families will be recruited before and after the MTB training. The MTB intervention is an attachment-based, interdisciplinary home visiting intervention offered from the third trimester of pregnancy until the child is 2 years old. The participants are assessed at baseline, and when the infant is 3, 12, and 24 months old. The primary outcome is maternal sensitivity measured by the Coding Interactive Behavior scale applied to video recordings of mother-infant interactions. Secondary outcomes include parent-child interaction, parental reflective functioning, parental mental health, maternal satisfaction, parental stress, and child development and well-being. The treatment effect is estimated as a fixed effect using a binary indicator of MTB treatment, and cluster-robust standard errors based on wild bootstrap are used for inference. DISCUSSION: This is the first trial of MTB in a Scandinavian context and will include the largest sample yet in a trial of MTB. The trial is expected to contribute to knowledge about the effect of early support for pregnant women, their infants, and their families at increased risk of adversity. TRIAL REGISTRATION: ClinicalTrials.gov NCT03495895 . The study was registered on April 12, 2018.

The FACAM study: protocol for a randomized controlled study of an early interdisciplinary intervention to support women in vulnerable positions through pregnancy and the first 5 years of motherhood.

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.

Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families: study protocol for a quasi-experimental trial.

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).