Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology

April 14, 2017 updated by: Karen Uzark, University of Michigan

Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology Requiring Neonatal Surgery

This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates born with single ventricle physiology. Half of the participants will receive early palliative care team consultation, while the other half will receive usual care (no or late palliative care intervention). The investigators hypothesize maternal stress, anxiety, and depression will be lower in the palliative care intervention group compared with the control group, and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mothers of children with congenital heart disease are at increased risk of psychological morbidity including stress, anxiety, and depression. In particular, mothers of patients with single ventricle physiology who require neonatal surgery, face a great deal of stress related to the risk of serious complications including neonatal death. Previous studies have suggested that providing emotional psychosocial support may modify the development of significant psychosocial problems in parents of children with congenital heart disease. The pediatric palliative care team specializes in multiple elements of psychological and spiritual care for families of such children.

The purpose of this pilot study is to evaluate maternal psychological distress and to examine the potential impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates born with single ventricle physiology. Mothers will complete four questionnaires measuring anxiety, depression, and quality of life/family functioning at a prenatal follow up visit and again prior to neonatal surgical hospital stay discharge (or at 30 days). Infants will be randomly assigned (by date of birth) to receive early palliative care team consultation or usual care (no or late palliative care intervention).

The investigators hypothesize maternal stress, anxiety, and depression will be lower in the palliative care intervention group compared with the control group, and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan C.S. Mott Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mothers pregnant with fetuses with single ventricle physiology who are planned to undergo staged single ventricle palliative surgery with the first surgery occurring in the neonatal period.

Exclusion Criteria:

  • Mothers with neonates born at a gestational age of less than 32 weeks requiring admission and management in the Neonatal Intensive Care Unit.
  • Mothers with neonates diagnosed with major non-cardiac congenital anomalies requiring additional surgical management beyond cardiac surgery in the neonatal period.
  • Non-English-speaking mothers who are unable to adequately comprehend and respond to survey questions administered as part of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early palliative care team consultation
Early pediatric palliative care team consultation for single ventricle patients will occur in this group following birth but prior to the first stage palliative surgery.
Behavioral: Early palliative care team consultation
The palliative care team will evaluate the patient and family with the following core palliative care goals in mind: evaluating maternal understanding of their child's diagnosis and eliciting maternal concerns regarding their child's physical symptoms, identifying maternal social support systems and additional life stressors, identifying maternal expectations and hopes for their child's medical care, and assessing maternal fears surrounding their child's diagnosis and medical treatments. Palliative care team support and resources will then be provided in areas of necessity identified for the family. Palliative care team follow up will then be determined based on the level of need identified for each individual study participant.
No Intervention: Usual care
Usual care for single ventricle patients will be provided with palliative care team consultation occurring at any point (if it is determined the child and family would benefit from palliative care consultation) during the child's neonatal hospital stay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maternal State-Trait Anxiety Index scores
Time Frame: Up to 4 weeks
Mothers will complete the State-Trait Anxiety Index to assess current anxiety symptoms and trait-like anxiety symptoms (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.
Up to 4 weeks
Change in maternal Beck Depression Index II scores
Time Frame: Up to 4 weeks
Mothers will complete the Beck Depression Index II to assess severity of depressive symptoms (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.
Up to 4 weeks
Change in maternal Brief Cope Inventory survey scores
Time Frame: Up to 4 weeks
Mothers will complete the Brief Cope Inventory to assess a broad range of coping responses (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.
Up to 4 weeks
Change in maternal PedsQL Family Impact Module survey scores
Time Frame: Up to 4 weeks
Mothers will complete the PedsQL Family Impact Module to measure the impact of the child's cardiac diagnosis on the parents and family to indicate parent functioning and overall family functioning (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of neonate's intensive care unit (ICU) stay in days
Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Continuous days of initial ICU stay from time of admission
Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Length of neonate's total hospital stay in days
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Continuous acute care inpatient hospital days from day of admission until discharge
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Hayley S Hancock, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

October 12, 2015

Study Completion (Actual)

November 15, 2016

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00072957

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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