Discussion
sleeping behavior
PHYSIOLOGICAL STRESS, SECONDARY
Dutch PCH professionals have the opportunity to support vulnerable families in early life, since they are in regular contact with most parents of young children. However, there is a lack of available, easily accessible evidence-based interventions for this target group [This study protocol presents the design of a non-randomized trial to evaluate the effects and the intervention process of Individual Shantala Infant Massage in the daily practice of PCH. It is hypothesized that the intervention will lead to an increase in parental sensitive responsiveness, lower reported and physiological stress of the parent and improved child growth and development in the intervention group, compared to a control group where the intervention is not part of the standard PCH care offer. Secondary hypotheses are that the intervention will lead to increased parenting confidence and a decrease of parental concerns (e.g. about crying, feeding and sleeping behavior of the infant). An exploratory secondary research question is whether specific subgroups profit more or less from this intervention. The intervention process is evaluated based on logbooks of professionals, questionnaires for parents and interviews.This study has several strengths. First, it is conducted in the daily practice of the PCH, which enables us to investigate the intervention in ‘real life’ rather than in an experimental setting, which supports the generalizability of our findings. Second, the study has a mixed-method design, combining information from multiple sources, including questionnaires, a physiological measurement of parental stress, PCH data on child growth and development, and an evaluation questionnaire, logbooks of the intervention sessions and interviews with both parents and professionals. However, the study also has limitations that need to be noted. The study is non-randomized, which may affect the comparability of the groups. In order to reduce the potential effects of non-randomization, we use a pre-post design. Furthermore, we attempt to control for possible group differences by assessing the most important confounders. However, the possibility of residual confounding remains and should be taken into account when interpreting the results. We also expect to encounter some challenges. The target group of the intervention, and thereby of this study, consists of parents with a young baby who may be vulnerable. This is a group where inclusion may be difficult and drop-out is to be expected. We hope to overcome this challenge by recruiting participants through and in close collaboration with PCH professionals who already are in direct contact with these parents. Furthermore, we try to lower the threshold to participate by making the study information accessible and comprehensible, by minimizing the burden by selecting questionnaires that are as short and as simple as possible, and by maintaining low-key contact with participants.This is the first controlled effect and process evaluation of the intervention Individual Shantala Infant Massage. The study can contribute to the evidence base of individual infant massage as applied in Dutch preventive child healthcare practice. As a result, the intervention may be acknowledged at a higher level of effectiveness in the national intervention database. Study results can inform parents, PCH professionals, researchers, and policy makers, both inside and outside the Netherlands, on the feasibility and effectiveness of the Individual Shantala Infant Massage intervention. A strengthened evidence base and insights on implementation and required conditions can help to facilitate a broader implementation of this intervention by other PCH organizations in the future. This contributes to easily accessible support for vulnerable families in order to reduce (effects) of stress and to improve positive parenting and parent-infant relationships.