## Protocol Section
### Identification Module
**NCT ID:** NCT06423092

**Brief Title:** Music Therapy Songwriting and Mental Health in Neonatel Intensive Care Unit (NICU) Parents

**Official Title:** Short-term Effectiveness of Music Therapy Songwriting on Mental Health Outcomes of At-risk Parents in the Neonatal Intensive Care Unit: an International Multicenter Mixed-methods Study.

#### Organization Study ID Info
**ID:** 166-23 UNV
#### Organization
**Class:** OTHER
**Full Name:** Sanitas University
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Sanitas University

#### Lead Sponsor

**Class:** OTHER

**Name:** Claudia Aristizábal

#### Responsible Party

**Investigator Affiliation:** Sanitas University

**Investigator Full Name:** Claudia Aristizábal

**Investigator Title:** Director

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health.

The main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.

**Detailed Description:** This study employs a multicenter, mixed-method approach, with a quantitative component that will be a pragmatic parallel controlled randomized clinical trial (RCT) and a qualitative component that will include phenomenological study. The quantitative component will assess depression and anxiety, which will be evaluated with the Edinburgh Postnatal Depression Scale (EPDS) and the Generalized Anxiety Disorder Scale (GAD-7), respectively. Secondary outcomes will be resilience, coping, stress, and mental well-being. These outcomes will be measured in the first week of hospitalization (baseline measure) and then in weeks 1, 2, and 3 of the intervention. Changes in scores will be assessed to identify the effect, and mediating variables will be determined by multivariate analysis. Semi-structured interviews will be conducted on the parents' experience of music therapy songwriting for the baby.

The study will provide data on the effect of music therapy songwriting on the mental health of parents of neonates with brain injuries (PTNB) versus standard care and will document the lived experience of music therapy songs. The results may inform the standardization of this strategy in neonatal intensive care units (NICUs) to support and accompany parents and decrease the impact on their mental health.

### Conditions Module

**Conditions:**

- Mental Health Impairment

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 102

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The music therapy songwriting is a method frequently employed in music therapy sessions. This method involves the collaborative creation of lyrics and/or music with the participants. The intervention will consist of nine sessions, each of which will last approximately 30 to 45 minutes. Three sessions will be conducted per week until a minimum of six and a maximum of nine sessions are achieved.

**Intervention Names:**

- Other: Music therapy songwriting

**Label:** Music therapy songwriting + standard care

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard care is the usual care provided to parents of newborns hospitalized in a neonatal intensive care unit (NICU). This care includes providing information about the baby's health status and recommendations during contact with the baby. Additionally, when a health professional identifies symptoms of mental health disturbance in the parents, they are referred to a mental health professional for appropriate management.

**Label:** Standard care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Music therapy songwriting + standard care

**Description:** Session 1: The goal of the first music therapy session is to know the parents musically and to provide information about song creation. This is achieved by exploring their favorite songs. Options for creating a song (original song or song parody) are presented and possibilities for creating lyrics are discussed.

Sessions 2-7: The structure of the song will be created and discussed with the parents. Parents will also be invited to include written messages from other family members in the lyrics if they wish. In each session, the developing welcome song is sung together with the parents, accompanied by the music therapist, who provides vocal or instrumental support.

The final sessions (Sessions 8-9) are dedicated to singing the final version of the song with the parents and their infant. Should the parents desire, a final recording of the song will also be made and the digital songbook will be created.

**Name:** Music therapy songwriting

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS).

**Measure:** Postpartum depression

**Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.

#### Secondary Outcomes

**Description:** Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).

**Measure:** Anxiety

**Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.

**Description:** The Warwick Edinburgh Mental Well-Being Scale (WEMWBS) will be employed to assess well-being.

**Measure:** Well-being

**Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.

**Description:** Resilience will be assessed with the Brief Resilience Scale (BRS).

**Measure:** Resilience

**Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.

**Description:** Stress will be assessed with the 10-item Perceived Stress Scale (PSS-10).

**Measure:** Stress

**Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.

**Description:** Stress response will be assessed with the Brief COPE Inventory (Brief-COPE).

**Measure:** Coping

**Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The study population consisted of parents/caregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected hospitalizations of at least three weeks. In the case of a twin pregnancy, the firstborn infant was randomly assigned to one of the intervention groups, while both infants received the same treatment according to the outcome of randomization.
* Mother a total score of ≥10 and/or father a total score of ≥7 on the EPDS (Edinburgh Postnatal Depression Scale)
* Mother and/or father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale)

Exclusion Criteria:

* Parents/caregivers with known auditory problems that prevent participation in MT.

Moreover parents/caregivers with a documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments.

* Parents/caregivers of premature infants in palliative or end-of-life care, infants with known hearing impairment, or infants in the custody of social services.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mark.ettenberger@gmx.at

**Name:** Mark Ettenberger, PhD

**Phone:** +57 311 284 7635

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Barranquilla

**Contacts:**

***Contact 1:***

- **Email:** mark.ettenberger@gmx.at

- **Name:** Mark Ettenberger, PhD

- **Phone:** +57 605 3319424

- **Role:** CONTACT

**Country:** Colombia

**Facility:** Clínica Iberoamérica en Colombia

**State:** Atlántico

**Location 2:**

**City:** Bogotá

**Contacts:**

***Contact 1:***

- **Email:** mark.ettenberger@gmx.at

- **Name:** Mark Ettenberger, PhD

- **Phone:** (+57) 601 745 5100

- **Role:** CONTACT

**Country:** Colombia

**Facility:** Clinica Pediátrica

**State:** Cundinamarca

**Location 3:**

**City:** Bogotá

**Contacts:**

***Contact 1:***

- **Email:** mark.ettenberger@gmx.at

- **Name:** Mark Ettenberger

- **Phone:** (+57) 6015948650

- **Role:** CONTACT

***Contact 2:***

- **Name:** Marcela Beltrán, MSc

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Mark Ettenberger, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Angélica Hernández, MSc

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Ana María Diaz, MSc

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Johana Benavides, MSc

- **Role:** SUB_INVESTIGATOR

**Country:** Colombia

**Facility:** Clínica Universitaria Colombia

**State:** Cundinamarca

**Location 4:**

**City:** Ibagué

**Contacts:**

***Contact 1:***

- **Email:** mark.ettenberger@gmx.at

- **Name:** Mark Ettenberger, PhD

- **Phone:** +57 60 1 646 6060

- **Role:** CONTACT

**Country:** Colombia

**Facility:** Clínica Keralty Ibagué

**State:** Tolima

**Location 5:**

**City:** Gdańsk

**Contacts:**

***Contact 1:***

- **Email:** lucja.bieleninik@ug.edu.pl

- **Name:** Łucja Bieleninik, PhD

- **Phone:** +48 58 523 30 00

- **Role:** CONTACT

***Contact 2:***

- **Name:** Łucja Bieleninik, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Ilona Poćwierz-Marciniak, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Poland

**Facility:** University of Gdańsk

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
