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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564184
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Haukeland University Hospital
University Hospital, Akershus
Oslo University Hospital
Meir Medical Center
Clinica de La Mujer
University of Haifa
University of Gdansk
King's College London
Universidad de Ciencias Empresariales y Sociales
Szpital Miejski w Rudzie Śląskiej
SONO - Centro de Musicoterapia
Hospital Materno Infantil Ramón Sardá
Hospital Fernandez
Information provided by (Responsible Party):
Christian Gold, NORCE Norwegian Research Centre AS

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Preterm Birth Behavioral: MT during NICU Behavioral: MT after NICU Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2 factorial, multinational, single-blind trial
Masking: Single (Outcomes Assessor)
Masking Description: Data collectors (for self-reports) and assessors (for observational measures) will be trained in assessment procedures and blinded to participant allocation. This will be ensured by using assessors from a different ward and by asking participants not to reveal their treatment assignments. Success of blinding will be verified.
Primary Purpose: Treatment
Official Title: Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial
Actual Study Start Date : August 25, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.




Primary Outcome Measures :
  1. Bonding between primary caregiver and infant [ Time Frame: 6 months ]
    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).


Secondary Outcome Measures :
  1. Bonding between primary caregiver and infant [ Time Frame: 12 months ]
    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).

  2. Child development [ Time Frame: 24 months ]
    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

  3. Infant development [ Time Frame: 12 months ]
    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.

  4. Infant socio-emotional development [ Time Frame: 12 months ]
    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.

  5. Re-hospitalization [ Time Frame: 12 months ]
    Re-hospitalization excluding outpatient visits, based on electronic health records. This will be calculated as the time from initial discharge until first re-hospitalization.

  6. Maternal depression [ Time Frame: 12 months ]
    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.

  7. Parental anxiety [ Time Frame: 12 months ]
    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.

  8. Parental stress [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564184


Contacts
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Contact: Claire Ghetti, PhD +4746508095 claire.ghetti@norceresearch.no

Locations
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Argentina
Hospital Materno Infantil Ramón Sardá Not yet recruiting
Buenos Aires, Caba, Argentina, 1246
Contact: Marcela Lichtensztejn, MA    +011 45433540    marcela.lichtensztejn@gmail.com   
Sanatorio Mater Dei Not yet recruiting
Buenos Aires, Caba, Argentina, C1425DND
Contact: Marcela Lichtensztejn, MA    +011 45433540    marcela.lichtensztejn@gmail.com   
Hospital Fernandez Recruiting
Buenos Aires, Argentina
Contact: Marcela Lichtenszteijn, MA    +011 45433540    marcela.lichtensztejn@gmail.com   
Colombia
Clinica de la Mujer Not yet recruiting
Bogotá, Colombia
Contact: Mark Ettenberger, PhD    +57 3112847635    mark.ettenberger@sono.la   
Fundación Santa Fe de Bogotá Recruiting
Bogotá, Colombia
Contact: Mark Ettenberger, PhD    +57 3112847635    mark.ettenberger@sono.la   
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 4428164
Contact: Cochavit Elefant, PhD    +972 4828 8801    celefant@univ.haifa.ac.il   
Norway
Haukeland University Hospital, Barne-og ungdomsklinikken Recruiting
Bergen, Hordaland, Norway, 5006
Contact: Bente J Vederhus, PhD    +47 55971453    bente.johanne.vederhus@helse-bergen.no   
Akershus University Hospital Recruiting
Oslo, Lørenskog, Norway, 1478
Contact: Anne Lee Solevåg, MD, PhD    +47 67960000    a.l.solevag@medisin.uio.no   
Oslo University Hospital, Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Trond H Diseth, MD, PhD    +47 23074940    trond.diseth@ous-hf.no   
Poland
Szpital Miejski w Rudzie Śląskiej Recruiting
Ruda Śląska, Poland, 41-703
Contact: Łucja Bieleninik, PhD    +48 504091477    lucja.bieleninik@ug.eud.pl   
Sponsors and Collaborators
NORCE Norwegian Research Centre AS
Haukeland University Hospital
University Hospital, Akershus
Oslo University Hospital
Meir Medical Center
Clinica de La Mujer
University of Haifa
University of Gdansk
King's College London
Universidad de Ciencias Empresariales y Sociales
Szpital Miejski w Rudzie Śląskiej
SONO - Centro de Musicoterapia
Hospital Materno Infantil Ramón Sardá
Hospital Fernandez
Investigators
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Study Chair: Christian Gold, PhD NORCE Norwegian Research Centre
Principal Investigator: Claire Ghetti, PhD Grieg Academy, University of Bergen
Additional Information:
Publications:
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Responsible Party: Christian Gold, Research Professor, NORCE Norwegian Research Centre AS
ClinicalTrials.gov Identifier: NCT03564184    
Other Study ID Numbers: RCN 273534
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christian Gold, NORCE Norwegian Research Centre AS:
Parent-infant bonding
Music therapy
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications