NCT04254718

Brief Summary

Our long-term goal is to reduce suffering and long-term negative consequences for families in the Neonatal Intensive Care Unit (NICU). The overall purpose of this study is to test feasibility of a legacy intervention for NICU parents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 12, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

January 31, 2020

Last Update Submit

September 27, 2021

Conditions

Bereavement

Keywords

NICU

Outcome Measures

Primary Outcomes (5)

  • Change in PROMIS Anxiety survey (short form)

    The PROMIS Anxiety (short form) survey measures the extent of anxiety. The range is 5-40, higher scores indicate higher anxiety

    Baseline and 1 month

  • Change in PROMIS Depression Survey (short form)

    The PROMIS Depression survey measures the extent of depression. The range is 5-40, with 5 being least depressed and 40 being the most depressed.

    Baseline and 1 month

  • Change in PROMIS Sleep Disturbance survey (short form)

    The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Scores range from 4-20. Low scores indicate better sleep and high scores indicate worse sleep.

    Baseline and 1 month

  • Change in PROMIS Meaning and Purpose survey (short form)

    The PROMIS Meaning and Purpose survey assess one's sense of life having purpose and that there are good reasons for living. Scores range from 6-30. Higher scores indicated perceptions of hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.

    Baseline and 1 month

  • Change in Benefit Finding Scale

    Benefit Finding Scale measures the degree of deriving positive growth from adversity. Scores range from 17-85 with high scores indicating more positive growth.

    Baseline and 1 month

Study Arms (1)

Digital Storytelling

EXPERIMENTAL

Legacy intervention via digital story for NICU parents

Behavioral: Digital Storytelling

Interventions

Digital StorytellingBEHAVIORAL

Creation of a digital story about the infant with video and music selected by parents

Digital Storytelling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of infants in the NICU who have received a palliative care consult and expected to die by 1 year of age based on provider report:
  • Parent caregivers (ages 18 years and up) of infants
  • Parents will be defined as the legal guardians who act in the role of the infant's primary and secondary parent caregivers based on parent self-report.
  • Able to speak and understand English
  • Absence of cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nolensville, Tennessee, 37135, United States

Location

Study Officials

  • Terrah Akard, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

October 12, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Locations

US(1)