Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers (LongSTEP)

Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial

Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.

Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.

Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Behavioral: MT during NICU; Behavioral: MT after NICU; Other: Standard care

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Fernandez
  • Caba
    • Buenos Aires, Caba, Argentina, 1246
      • Hospital Materno Infantil Ramón Sardá
    • Buenos Aires, Caba, Argentina, C1425DND
      • Sanatorio Mater Dei
• Colombia
  • Bogotá, Colombia
    • Fundacion Santa Fe de Bogota
  • Bogotá, Colombia
    • Clinica de la Mujer
• Israel
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital, Rikshospitalet
  • Hordaland
    • Bergen, Hordaland, Norway, 5006
      • Haukeland University Hospital, Barne-og ungdomsklinikken
  • Lørenskog
    • Oslo, Lørenskog, Norway, 1478
      • Akershus University Hospital
• Poland
  • Ruda Śląska, Poland, 41-703
    • Szpital Miejski w Rudzie Śląskiej

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (infants):

• born below 35 weeks gestational age
• determined by medical staff to have achieved sufficient medical stability to start MT
• likely to be hospitalized longer than 2 weeks from time of recruitment

Inclusion Criteria (parents):

• willing to engage in at least 2 of 3 MT sessions per week during NICU and/or in 5 of 7 MT post-discharge sessions, if randomized to receive MT
• live with reasonable commuting distance from the treating NICU
• sufficient understanding of the respective national language(s) to answer questionnaires and participate in MT

Exclusion Criteria (parents):

• documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MT during and after NICU; Consists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care.	Behavioral: MT during NICU; Music therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care.; Behavioral: MT after NICU; Music therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs.; Other: Standard care; Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
EXPERIMENTAL: MT during NICU; Consists of music therapy during NICU hospitalization, along with standard care.	Behavioral: MT during NICU; Music therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care.; Other: Standard care; Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
EXPERIMENTAL: MT after NICU; Consists of music therapy after discharge from initial NICU hospitalization, along with standard care.	Behavioral: MT after NICU; Music therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs.; Other: Standard care; Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
EXPERIMENTAL: No MT; Consists of standard care.	Other: Standard care; Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bonding between primary caregiver and infant	Total score of the Postpartum Bonding Questionnaire (PBQ), a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bonding between primary caregiver and infant	Total score of the Postpartum Bonding Questionnaire (PBQ), a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).	12 months
Child development	Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III), standardized with a population mean of 100 (SD 15), with higher scores indicating better development	24 months
Infant development	Ages and Stages Questionnaire, 3rd edition (ASQ-3), an age-specific parent-reported screening questionnaire consisting of 30 items, total sum score ranging from 0 to 300, with higher scores indicating better development.	12 months
Infant socio-emotional development	Ages and Stages Questionnaire Social-Emotional (ASQ:SE), a parent-completed questionnaire with 19 or 22 Likert-scaled items (each 0-5-10), plus additional items for whether an item is of concern to the parent (each 0-5), resulting in a score ranging from 0-285 or 0-300, at 6 and 12 months respectively. Lower scores indicate better socio-emotional development.	12 months
Re-hospitalization	Re-hospitalization excluding outpatient visits, based on electronic health records. This will be calculated as the time from initial discharge until first re-hospitalization.	12 months
Maternal depression	Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report instrument assessing mothers' postpartum depressive symptoms, excluding somatic symptoms of depression that are common in new mothers (such as loss of energy, feeling tired, changes in appetite and sexual drive). Sum scores can range from 0 to 30, with high scores indicating more depressive symptoms.	12 months
Parental anxiety	Generalized Anxiety Disorder Assessment (GAD-7), a self-report 7-item questionnaire serving as a screening tool and severity measure for generalized anxiety disorder. Sum scores can range from 0 to 21, with higher scores indicating higher anxiety.	12 months
Parental stress	Parental Stress Scale (PSS), a self-report 18-item questionnaire that assesses stress associated with parenting. Sum scores can range from 18 to 90, with higher scores indicating higher stress.	12 months

Collaborators and Investigators

• Sponsor: NORCE Norwegian Research Centre AS
• Collaborators: King's College London; Oslo University Hospital; Meir Medical Center; Haukeland University Hospital; University Hospital, Akershus; University of Haifa; Hospital Fernandez; University of Gdansk; Clinica de La Mujer; Universidad de Ciencias Empresariales y Sociales; Szpital Miejski w Rudzie Śląskiej; SONO - Centro de Musicoterapia; Hospital Materno Infantil Ramón Sardá
• Investigators: Study Chair: Christian Gold, PhD, NORCE Norwegian Research Centre; Principal Investigator: Claire Ghetti, PhD, Grieg Academy, University of Bergen

Publications and helpful links

General Publications

• Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
• Ghetti C, Bieleninik L, Hysing M, Kvestad I, Assmus J, Romeo R, Ettenberger M, Arnon S, Vederhus BJ, Soderstrom Gaden T, Gold C. Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial. BMJ Open. 2019 Sep 3;9(8):e025062. doi: 10.1136/bmjopen-2018-025062.
• Gaden TS, Ghetti C, Kvestad I, Bieleninik L, Stordal AS, Assmus J, Arnon S, Elefant C, Epstein S, Ettenberger M, Lichtensztejn M, Lindvall MW, Mangersnes J, Roed CJ, Vederhus BJ, Gold C. Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. Pediatrics. 2022 Feb 1;149(2):e2021052797. doi: 10.1542/peds.2021-052797.

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 25, 2018
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): August 31, 2022

Study Registration Dates

• First Submitted: June 10, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (ACTUAL): June 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Music therapy; Parent-infant bonding
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: RCN 273534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To promote transparency and applicability of trial results and to facilitate re- analysis by other researchers while also protecting anonymity, de-identified individual patient data will be made available through the Norwegian Centre for Research Data (NSD).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No