The effects and process of the intervention “Individual Shantala Infant Massage” in preventive child healthcare to improve parent–child interaction: study protocol for a quasi-experimental study

Background Individual Shantala Infant Massage is an intervention that is offered by several Dutch Preventive Child Healthcare (PCH) organizations as optional preventive support, in addition to basic care as offered to all children. It targets vulnerable families and aims to enhance sensitive parenting and to reduce (effects of) parental stress. The intervention is carried out by a certified nurse. It consists of three structured home visits. Parents learn to massage their infant and receive parenting support. This study aims to investigate the effectiveness and the process of the intervention. The main hypothesis is that Individual Shantala Infant Massage leads to increased parental sensitive responsiveness, lower perceived and physiological parental stress, and improved child growth and development in the intervention group, compared to a control group where this intervention is not offered by PCH. Secondary research questions address effects on parenting confidence and parental concerns regarding the infant, the influence of background characteristics and the intervention process. Methods The study is a quasi-experimental non-randomized trial. The aim is to include 150 infant-parent dyads in both the intervention and the control group. This takes into account possible attrition and missing data as 105 dyads with complete data per group are sufficient for analysis. All participants complete questionnaires at T0 (pre-test, child age between six-sixteen weeks), T1 (post-intervention, or ± four weeks after T0), and T2 (follow-up at five months). At T2, a hair tuft is cut from the parents’ head to measure hair cortisol levels. Data on infant growth and development is obtained from PCH files. In the intervention group, additional data is collected to evaluate the intervention process: parents complete an evaluation questionnaire at T1, nurses keep semi-structured logbooks of intervention sessions and interviews are conducted with parents and professionals. Discussion Study results can contribute to the evidence base of infant massage as applied in Dutch PCH, and can inform parents, PCH practitioners, policy makers and researchers both inside and outside the Netherlands on feasibility and effectiveness of the infant massage intervention as applied in this format and setting. Trial registration ISRCTN registry: ISRCTN16929184. Date (retrospectively) registered: 29/03/2022.