Flow-chart illustrating the design Longitudinal impact of music therapy on premature infants and their caregivers: Study protocol for a feasibility randomized controlled trial Łucja Bieleninik1, Claire Ghetti2, Hanne Cecilie Braarud3, Christian Gold1 1Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway 2 Grieg Academy Music Therapy Research Centre, University of Bergen, Bergen, Norway 3 Uni Research Health, Regional Centre for Child and Youth Mental Health and Child Welfare, Bergen, Norway LongSTEP Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers Study design Flow-chart illustrating the design This study is a factorial (2x2), two-arm, single-centre, assessor-blind pragmatic randomised controlled trial (pRCT) to evaluate the longitudinal effect of music therapy (MT) in neonatal intensive care unit (NICU) and/or after discharge to home on premature infants and their primary caregivers across a 12-month time period. This will enable testing the independent effect of each combination – MT during NICU hospitalization, MT after discharge from hospital, or both, or neither – as well as interactions between them. MT will be delivered during NICU hospitalization and post-discharge across a 6-month time period. This trial will determine whether MT as delivered by a qualified music therapist during NICU hospitalization and/or after discharge to home is superior to standard care in improving long-term outcomes for families. Note. CA – corrected age; CG – control group; IG – intervention group. Objectives Outcomes ADBB –Alarm Distress Baby Scale; ASQ: SE – Ages and Stages Questionnaire: Social-Emotional; BSID – Bayley Scales of Infant and Toddler Development; EPDS – Edinburgh Postnatal Depression Scale; Med – medical outcomes; PBQ – Postpartum Bonding Questionnaire; PSI – Parenting Stress Index. Primary objective: 1. To determine the feasibility of music therapy during NICU hospitalization and post-discharge from hospital in relation to acceptability, start point, end point, and dosage. Secondary objectives: 1. To determine the appropriate eligibility criteria of the sample entering the feasibility trial for its representation of the target population. 2. To determine willingness of participants to be randomised. 3. To estimate recruitment and retention rates. 4. To estimate the completeness of outcome data. 5. To calculate sample size for a subsequent definitive multi-center trial based on measured changes in performance for both the control and two intervention groups. Summary 1. The proposed project marks the first feasibility trial of music therapy’s effectiveness for preterm infants and caregivers in Norway. 2. The project serves as the first crucial step towards a definitive high quality international multi-centre study that would provide a more generalizable, rigorously designed, and adequately powered trial. 3. The pragmatic nature of this feasibility trial and its high clinical applicability are reflected in several dimensions. 4. The project will strengthen interdisciplinary collaboration, and findings will have an important impact for infants from an at-risk group, their primary caregivers, music therapists, and for practitioners working with them. Contact to Łucja Bieleninik: lucja.bieleninik@uni.no