Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Feeding Behavior; Preterm Infant; Mother-Infant Interaction; Stress

Treatments: Behavioral: Stress and Feeding (SAFE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03664154

HM20013532

Details and patient eligibility

About

A majority of mothers experience high stress levels and associated symptoms of anxiety, depressive symptoms, and sleep disruption during the NICU hospitalization and continuing after hospital discharge. Given preterm infant feeding is one of the most stressful things the new mother will face and given the harmful nature of stress on maternal and infant health, it is important an intervention focuses on both of these concerns: infant feeding and maternal stress. Therefore, the purpose of this research study is two-fold. First, the investigators will examine how practical and acceptable it is for mothers of preterm infants to participate in Stress And FEeding (SAFE) intervention and collect biological stress measures from mothers and their preterm infant's saliva (spit). The intervention is designed to reduce stress and improve maternal feeding interaction. The second purpose of this study is to examine changes before and after using the intervention on mother and infant outcomes over 16-weeks.

Full description

Descriptive statistics will be computed for demographic and outcome variables. The number of mother/infant dyads recruited but not enrolled will be tracked. If provided, reasons for non-participation will be noted. Enrolled dyads will be tracked and monitored for the number of times the interventions are used and completeness of study data. Acceptability and burden will be assessed by theme analysis of the responses to the interview by the mPI's using traditional strategies of reading and re-reading the transcripts, coding participant responses using their language, and developing categories and subcategories to create a structure for considering acceptability will be completed.. Finally, perceptions of usefulness and satisfaction of the mothers will be assessed by looking at frequencies of Likert responses.

Means and standard errors of the maternal stress and feeding behavior variables will be estimated and graphed across the data collection time points. Although the sample size is small, it is anticipated the mixed effects linear model will be used to assess and quantify changes across time. This model will include a random effect for participant and a fixed effect for time. The model is flexible enough to model potential cofactors, such as age at birth. The study will track the number of successfully obtained, transported, processed and stored samples and compare those number to the proposed maternal and infant cortisol collections.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Maternal Inclusion Criteria:

• English-speaking and reading
• Given birth to preterm infant < 35-weeks gestation
• Has access to internet
• Lives within 50-mile radius of hospital

Infant Inclusion Criteria:

• Born less than 35 week gestation
• No congenital anomalies that could interfere with feeding (e.g., diaphragmatic hernia, cleft lip/palate tracheoesophageal fistula, and cardiac anomalies

Maternal Exclusion Criteria:

• Chronic neuroendocrine or immunologic condition
• Currently using guided imagery or other mind-body techniques such as meditation
• Psychiatric disorder involving a history of dissociative disorders, borderline personalities, and psychotic pathology

Infant Exclusion Criteria:

• Grade III or IV intraventricular hemorrhage
• Surgical necrotizing enterocolitis

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Stress and Feeding (SAFE)

Experimental group

Description:

The SAFE intervention is grounded in a general theory of guided participation (GP) that posits learning will be facilitated by an emotionally regulated state of the mother. Efforts to help mothers manage stress will better position them to learn and attend to feeding their infants. GP links the two components: stress management (SM) and guided feeding (GF). SM provides skills to manage perceived stress and regulate emotion. GF provides education with skill building to help mothers become more sensitive and responsive to their infant. SAFE is delivered through a secure, password-protected responsive website with practice opportunities.

Treatment:

Behavioral: Stress and Feeding (SAFE)