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

Not Applicable

Completed

• Conditions: Single Ventricle Defect; Stress, Psychological; Heart Defects, Congenital; Hypoplastic Left Heart Syndrome
• Interventions: Behavioral: Early palliative care team consultation

• Registration Number: NCT02462434
• Lead Sponsor: University of Michigan

Brief Summary

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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-04
• Primary Completion: 2015-10-12
• Study Completion: 2016-11-15
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-14
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early palliative care team consultation	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.

Primary Outcome Measures

Name	Time	Method
Change in maternal Brief Cope Inventory survey scores	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.
Change in maternal State-Trait Anxiety Index scores	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.
Change in maternal PedsQL Family Impact Module survey scores	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.
Change in maternal Beck Depression Index II scores	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.

Secondary Outcome Measures

Name	Time	Method
Length of neonate's intensive care unit (ICU) stay in days	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
Length of neonate's total hospital stay in days	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

Trial Locations

Locations (1)

University of Michigan C.S. Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States